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Guideline Summary
Guideline Title
2011 ACCF/AHA/SCAI guideline for percutaneous coronary artery intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.
Bibliographic Source(s)
American College of Cardiology Foundation, American Heart Association Task Force on Practice Guidelines, Society for Cardiovascular Angiography and Interventions, Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44–122. [879 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates previous versions:

King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O'Neill WW, Schaff HV, Whitlow PL, ACC/AHA/SCAI, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol 2008 Jan 15;51(2):172-209.

Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Assoc Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to update the 2001 guidelines for PCI). Bethesda (MD): American College of Cardiology Foundation (ACCF); 2005. 122 p.

Scope

Disease/Condition(s)

Coronary artery disease, including:

  • Silent ischemic heart disease (SIHD)
  • Unstable angina/non-ST-elevation myocardial infarction (NSTEMI)
  • ST-elevation myocardial infarction (STEMI)
Guideline Category
Evaluation
Management
Risk Assessment
Treatment
Clinical Specialty
Cardiology
Family Practice
Geriatrics
Internal Medicine
Surgery
Intended Users
Physicians
Guideline Objective(s)
  • To assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions
  • To define practices that meet the needs of most patients in most circumstances
  • To assist physicians in selecting the best management strategy for an individual patient
Target Population

Patients with coronary artery disease

Interventions and Practices Considered
  1. Coronary artery disease revascularization:
    • Coronary artery bypass grafts
    • Percutaneous coronary interventions (PCI), including drug-eluting stents, rotational atherectomy, embolic protection devices, vascular closure devices, hemodynamic support device insertion, cutting balloon angioplasty, laser angioplasty, aspirational thrombectomy
    • Heart Team approach
    • Medical therapy
    • Hybrid coronary revascularization
  2. Preprocedural considerations:
    • Assessment of risk for acute kidney injury
    • Anaphylactic reaction considerations
    • Evaluation of bleeding risk
  3. Procedural considerations:
    • Radial artery access
    • PCI in specific situations (unstable angina/non-ST-segment elevation myocardial infarction [UA/NSTEMI], cardiogenic shock, before noncardiac surgery)
    • Use of adjunctive diagnosis devices (fractional flow reserve [FFR], intravascular ultrasound [IVUS])
    • Use of adjunctive therapeutic devices (coronary atherectomy, thrombectomy, laser angioplasty, cutting balloon angioplasty, embolic protection devices)
    • Percutaneous hemodynamic support devices
    • Interventional pharmacotherapy, including oral antiplatelet therapy, intravenous antiplatelet therapy, anticoagulant therapy, no-reflow pharmacological therapies
    • PCI in specific anatomic situations (chronic total occlusions [CTO], saphenous vein grafts [SVGs], bifurcation lesions, aorto-ostial stenoses, calcified lesions)
    • PCI in specific patient populations (elderly, diabetics, women, chronic kidney disease, cardiac allografts)
    • Myocardial infarction assessment
    • Use of vascular closure devices
  4. Postprocedural considerations:
    • Antiplatelet therapy
    • Management of restenosis
    • Clinical follow-up: exercise testing, rehabilitation
  5. Insurance of institutional and operator competency in performing PCI (quality assurance programs, high-volume operators in high-volume institutions, availability of onsite cardiac surgical back-up or access to cardiac surgical back-up, radiation safety)
Major Outcomes Considered
  • Success rates of percutaneous coronary intervention (PCI) procedures as defined by angiographic, procedural, and clinical criteria (relief of signs and symptoms, rate of restenosis)
  • Rates of procedural complications of PCI, such as: death, myocardial infarction, emergency coronary artery bypass graft (CABG), stroke, vascular access site complications, and contrast agent nephropathy
  • Long-term (5- and 10-year) survival rates and event-free survival rates
  • Medication interactions/reactions
  • Occurrence and severity of restenosis
  • Risk of bleeding
  • Cardiogenic shock

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

An extensive evidence review was conducted through November 2010, as well as selected other references through August 2011. Searches were limited to studies, reviews, and other evidence conducted in human subjects and that were published in English. Key search words included but were not limited to the following: ad hoc angioplasty, angioplasty, balloon angioplasty, clinical trial, coronary stenting, delayed angioplasty, meta-analysis, percutaneous transluminal coronary angioplasty, randomized controlled trial (RCT), percutaneous coronary intervention (PCI) and angina, angina reduction, antiplatelet therapy, bare-metal stents, cardiac rehabilitation, chronic stable angina, complication, coronary bifurcation lesion, coronary calcified lesion, coronary chronic total occlusion (CTO), coronary ostial lesions, coronary stent (BMS and drug-eluting stents [DES]; and BMS versus DES), diabetes, distal embolization, distal protection, elderly, ethics, late stent thrombosis, medical therapy, microembolization, mortality, multiple lesions, multi-vessel, myocardial infarction (MI), non–ST-elevation myocardial infarction (NSTEMI), no-reflow, optical coherence tomography, proton pump inhibitor (PPI), return to work, same-day angioplasty and/or stenting, slow flow, stable ischemic heart disease (SIHD), staged angioplasty, STEMI, survival, and unstable angina (UA). Additional searches cross-referenced these topics with the following subtopics: anticoagulant therapy, contrast nephropathy, PCI-related vascular complications, unprotected left main PCI, multivessel coronary artery disease (CAD), adjunctive percutaneous interventional devices, percutaneous hemodynamic support devices, and secondary prevention.

Additionally, the committee reviewed documents related to the subject matter previously published by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA). References selected and published in this document are representative and not all-inclusive.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Applying Classification of Recommendations and Level of Evidence

  Size of Treatment Effect
  CLASS I

Benefit >>> Risk

Procedure/Treatment
SHOULD be performed/administered
CLASS IIa

Benefit >> Risk
Additional studies with focused objectives needed


IT IS REASONABLE to perform procedure/administer treatment
CLASS IIb

Benefit ≥ Risk
Additional studies with broad objectives needed; additional registry data would be helpful


Procedure/Treatment
MAY BE CONSIDERED
CLASS III No Benefit
or Class III Harm
  Procedure/Test Treatment
COR III:
No Benefit
Not helpful No proven benefit
COR III:
Harm
Excess Cost without Benefit or Harmful Harmful to Patients
Estimate of Certainty (Precision) of Treatment Effect LEVEL A

Multiple populations evaluated*

Data derived from multiple randomized clinical trials or meta-analyses
  • Recommendation that procedure or treatment is useful/effective
  • Sufficient evidence from multiple randomized trials or meta-analyses
  • Recommendation in favor of treatment or procedure being useful/effective
  • Some conflicting evidence from multiple randomized trials or meta-analyses
  • Recommendation's usefulness/efficacy less well established
  • Greater conflicting evidence from multiple randomized trials or meta-analyses
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Sufficient evidence from multiple randomized trials or meta-analyses
LEVEL B

Limited populations evaluated*

Data derived from a single randomized clinical trials or nonrandomized studies
  • Recommendation that procedure or treatment is useful/effective
  • Evidence from single randomized trial or nonrandomized studies
  • Recommendation in favor of treatment or procedure being useful/effective
  • Some conflicting evidence from single randomized trial or nonrandomized studies
  • Recommendation's usefulness/efficacy less well established
  • Greater conflicting evidence from single randomized trial or nonrandomized studies
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Evidence from single randomized trial or nonrandomized studies
LEVEL C

Very limited populations evaluated*

Only consensus opinion of experts, case studies or standard of care
  • Recommendation that procedure or treatment is useful/effective
  • Only expert opinion, case studies, or standard of care
  • Recommendation in favor of treatment or procedure being useful/effective
  • Only diverging expert opinion, case studies, or standard of care
  • Recommendation's usefulness/efficacy less well established
  • Only diverging expert opinion, case studies, or standard of care
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Only expert opinion, case studies, or standard-of-care

A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.

*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm will be provided in the guideline, along with confidence intervals (CIs) and data related to the relative treatment effects such as odds ratio (OR), relative risk, hazard ratio (HR), or incidence rate ratio.

In analyzing the data and developing recommendations and supporting text, the writing committee uses evidence-based methodologies developed by the Task Force. The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective or in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing committee reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C according to specific definitions (see the "Rating Scheme for the Strength of the Evidence" field). Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing committee is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1 (see the "Rating Scheme for the Strength of the Evidence" field), which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Class III recommendations to delineate if the recommendation is determined to be of "no benefit" or is associated with "harm" to the patient. In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another have been added for COR I and IIa, LOE A or B only.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Experts in the subject under consideration are selected by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) to examine subject-specific data and write guidelines in partnership with representatives from other medical organizations and specialty groups. Writing committees are asked to perform a formal literature review; weigh the strength of evidence for or against particular tests, treatments, or procedures; and include estimates of expected outcomes where such data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein. In analyzing the data and developing recommendations and supporting text, the writing committee uses evidence-based methodologies developed by the Task Force.

Rating Scheme for the Strength of the Recommendations

See the "Rating Scheme for the Strength of the Evidence" field, above.

Cost Analysis

Published cost analyses were reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

This document was reviewed by 2 official reviewers nominated by the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and Society for Cardiac Angiography and Interventions (SCAI), as well as 21 individual content reviewers (including members of the ACCF Interventional Scientific Council and ACCF Surgeons' Scientific Council). All information on reviewers' relationship with industry was distributed to the writing committee and is published in Appendix 2 of the original guideline document.

This document was approved by the American College of Cardiology Foundation Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in July 2011, and the Society for Cardiovascular Angiography and Interventions in August 2011.

Recommendations

Major Recommendations

Definitions for the weight of the evidence (A-C) and classes of recommendations (I-III) are provided at the end of the "Major Recommendations" field.

Coronary Artery Disease (CAD) Revascularization

Heart Team Approach to Revascularization Decisions

Class I

  1. A Heart Team approach to revascularization is recommended in patients with unprotected left main or complex CAD (Serruys et al., 2009; Feit et al., 2000; King et al., 1997). (Level of Evidence: C)

Class IIa

  1. Calculation of the Society of Thoracic Surgeons (STS) and the SYNTAX scores is reasonable in patients with unprotected left main and complex CAD (Morice et al., 2010; Serruys et al., 2009; Chakravarty et al., 2011; Grover et al., 2001; Kim et al., 2010; Shahian et al., 2009; Shahian et al., 2010; Welke et al., 2007). (Level of Evidence: B)

Revascularization to Improve Survival

Left Main CAD Revascularization

Class I

  1. Coronary artery bypass graft (CABG) to improve survival is recommended for patients with significant (≥50% diameter stenosis) left main coronary artery stenosis (Caracciolo et al., 1995; Chaitman et al., 1981; Dzavik et al., 2001; Takaro et al., 1976; Takaro et al., 1982; Taylor et al., 1989; Yusuf et al., 1994). (Level of Evidence: B)

Class IIa

  1. Percutaneous coronary intervention (PCI) to improve survival is reasonable as an alternative to coronary artery bypass grafting (CABG) in selected stable patients with significant (≥50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low risk of PCI procedural complications and a high likelihood of good long-term outcome (e.g., a low SYNTAX score [≤22], ostial or trunk left main CAD); and 2) clinical characteristics that predict a significantly increased risk of adverse surgical outcomes (e.g., STS-predicted risk of operative mortality ≥5%) (Morice et al., 2010; Chakravarty et al., 2011; Kim et al., 2010; Buszman et al., 2008; Capodanno et al., 2011; Hannan et al., 2008; Ellis et al., 1997; Biondi-Zoccai et al., 2008; Boudriot et al., 2011; Brener et al., 2008; Chieffo et al., 2010; Chieffo et al., 2006; Lee, et al., 2006; Makikallio et al., 2008; Naik et al., 2009; Palmerini et al., 2006; Park et al., 2010; Rodes-Cabau et al., 2008; Sanmartin et al., 2007; Kappetein et al., 2011; Seung et al., 2008; White et al., 2008). (Level of Evidence: B)
  2. PCI to improve survival is reasonable in patients with unstable angina/non ST-elevation myocardial infarction (UA/NSTEMI) when an unprotected left main coronary artery is the culprit lesion and the patient is not a candidate for CABG (Morice et al., 2010; Brener et al., 2008; Chieffo et al., 2010; Chieffo et al., 2006; Lee et al., 2006; Rodes-Cabau et al., 2008; Sanmartin et al., 2007; Seung et al., 2008; White et al., 2008; Montalescot et al., "Unprotected," 2009). (Level of Evidence: B)
  3. PCI to improve survival is reasonable in patients with acute ST-Elevation Myocardial Infarction (STEMI) when an unprotected left main coronary artery is the culprit lesion, distal coronary flow is less than Thrombolysis In Myocardial Infarction (TIMI) grade 3, and PCI can be performed more rapidly and safely than CABG (Ellis et al., 1997; Lee et al., 2008; Lee et al., 2010). (Level of Evidence: C)

Class IIb

  1. PCI to improve survival may be reasonable as an alternative to CABG in selected stable patients with significant (≥50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low to intermediate risk of PCI procedural complications and an intermediate to high likelihood of good long-term outcome (e.g., low-intermediate SYNTAX score of <33, bifurcation left main CAD); and 2) clinical characteristics that predict an increased risk of adverse surgical outcomes (e.g., moderate-severe chronic obstructive pulmonary disease, disability from previous stroke, or previous cardiac surgery; STS-predicted risk of operative mortality >2%) (Morice et al., 2010; Chakravarty et al., 2011; Kim et al., 2010; Buszman et al., 2008; Capodanno et al., 2011; Hannan et al., 2008; Ellis et al., 1997; Biondi-Zoccai et al., 2008; Boudriot et al., 2011; Brener et al., 2008; Chieffo et al., 2010; Chieffo et al., 2006; Lee et al., 2006; Makikallio et al., 2008; Naik et al., 2009; Palmerini et al., 2006; Park et al., 2010; Rodes-Cabau et al., 2008; Sanmartin et al., 2007; Kappetein et al., 2011; Seung et al., 2008; White et al., 2008; Park et al., 2011). (Level of Evidence: B)

Class III: HARM

  1. PCI to improve survival should not be performed in stable patients with significant (≥50% diameter stenosis) unprotected left main CAD who have unfavorable anatomy for PCI and who are good candidates for CABG (Morice et al., 2010; Chakravarty et al., 2011; Kim et al., 2010; Caracciolo et al., 1995; Chaitman et al., 1981; Dzavik et al., 2001; Takaro et al., 1976; Takaro et al., 1982; Taylor et al., 1989; Yusuf et al., 1994; Capodanno et al., 2011; Hannan et al., 2008). (Level of Evidence: B)

Non–Left Main CAD Revascularization

Class I

  1. CABG to improve survival is beneficial in patients with significant (≥70% diameter) stenoses in 3 major coronary arteries (with or without involvement of the proximal left anterior descending [LAD] artery) or in the proximal LAD plus 1 other major coronary artery (Dzavik et al., 2001; Yusuf et al., 1994; Jones et al., 1996; Myers et al., 1989; Varnauskas, 1988; Smith et al., 2006). (Level of Evidence: B)
  2. CABG or PCI to improve survival is beneficial in survivors of sudden cardiac death with presumed ischemia-mediated ventricular tachycardia caused by significant (≥70% diameter) stenosis in a major coronary artery. (CABG Level of Evidence: B [Borger van der Burg et al., 2003; Every et al., 1992; Kaiser et al., 1975]; PCI Level of Evidence: C [Borger van der Burg et al., 2003])

Class IIa

  1. CABG to improve survival is reasonable in patients with significant (≥70% diameter) stenoses in 2 major coronary arteries with severe or extensive myocardial ischemia (e.g., high-risk criteria on stress testing, abnormal intracoronary hemodynamic evaluation, or >20% perfusion defect by myocardial perfusion stress imaging) or target vessels supplying a large area of viable myocardium (Di Carli et al., 1998; Hachamovitch et al., 2003; Sorajja et al., 2005; Davies et al., 1997). (Level of Evidence: B)
  2. CABG to improve survival is reasonable in patients with mild- moderate left ventricular (LV) systolic dysfunction (ejection fraction [EF] 35% to 50%) and significant (≥70% diameter stenosis) multi vessel CAD or proximal LAD coronary artery stenosis, when viable myocardium is present in the region of intended revascularization (Yusuf et al., 1994; Alderman et al., 1983; O'Connor et al., 2002; Phillips, O'Connor, & Rogers, 2007; Tarakji et al., 2006; Tsuyuki et al., 2006). (Level of Evidence: B)
  3. CABG with a left internal mammary artery (LIMA) graft to improve survival is reasonable in patients with significant (≥70% diameter) stenosis in the proximal LAD artery and evidence of extensive ischemia (Yusuf et al., 1994; Smith et al., 2006; Cameron et al., 1996; Loop et al., 1986). (Level of Evidence: B)
  4. It is reasonable to choose CABG over PCI to improve survival in patients with complex 3-vessel CAD (e.g., SYNTAX score >22), with or without involvement of the proximal LAD artery who are good candidates for CABG (Hannan et al., 2008; Kappetein et al., 2011; Smith et al., 2006; Brener et al., 2004; Hannan et al., "Long-term," 2005). (Level of Evidence: B)
  5. CABG is probably recommended in preference to PCI to improve survival in patients with multivessel CAD and diabetes mellitus, particularly if a LIMA graft can be anastomosed to the LAD artery (Sorajja et al., 2005; "Influence of diabetes," 1997; The BARI Investigators, 2007; Banning et al., 2010; Hoffman et al., 2003; Hueb et al., 2007; Malenka et al., 2005; Niles et al., 2001; Weintraub et al., 1998). (Level of Evidence: B)

Class IIb

  1. The usefulness of CABG to improve survival is uncertain in patients with significant (≥70%) diameter stenoses in 2 major coronary arteries not involving the proximal LAD artery and without extensive ischemia (Smith et al., 2006). (Level of Evidence: C)
  2. The usefulness of PCI to improve survival is uncertain in patients with 2- or 3-vessel CAD (with or without involvement of the proximal LAD artery) or 1-vessel proximal LAD disease (Dzavik et al., 2001; Jones et al., 1996; Smith et al., 2006; Boden et al., 2007). (Level of Evidence: B)
  3. CABG might be considered with the primary or sole intent of improving survival in patients with silent ischemic heart disease (SIHD) with severe LV systolic dysfunction (EF <35%) whether or not viable myocardium is present (Yusuf et al., 1994; Alderman et al., 1983; O'Connor et al., 2002; Phillips, O'Connor, & Rogers, 2007; Tarakji et al., 2006; Tsuyuki et al., 2006; Bonow et al., 2011; Velazquez et al., 2011). (Level of Evidence: B)
  4. The usefulness of CABG or PCI to improve survival is uncertain in patients with previous CABG and extensive anterior wall ischemia on noninvasive testing (Brener et al., 2006; Gurfinkel et al., 2007; Lytle et al., 1993; Morrison et al., 2001; Pfautsch et al., 1999; Sergeant et al., 1998; Stephan et al., 1996; Subramanian et al., 2009; Weintraub et al., 1997). (Level of Evidence: B)

Class III: HARM

  1. CABG or PCI should not be performed with the primary or sole intent to improve survival in patients with SIHD with 1 or more coronary stenoses that are not anatomically or functionally significant (e.g., 70% diameter non–left main coronary artery stenosis, fractional flow reserve [FFR] >0.80, no or only mild ischemia on noninvasive testing), involve only the left circumflex or right coronary artery, or subtend only a small area of viable myocardium (Yusuf et al., 1994; Jones et al., 1996; Di Carli et al., 1998; Hachamovitch et al., 2003; Shaw et al., 2008; Cashin et al., 1984; Pijls et al., 1996; Tonino et al., 2009; Sawada et al., 2003). (Level of Evidence: B)

Revascularization to Improve Symptoms

Class I

  1. CABG or PCI to improve symptoms is beneficial in patients with 1 or more significant (≥70% diameter) coronary artery stenoses amenable to revascularization and unacceptable angina despite guideline-directed medical treatment (GDMT) (Boden et al., 2007; TIME Investigators, 2001; Benzer, Hofer, & Oldridge, 2003; Bonaros et al., 2005; Bucher et al., 2000; Favarato et al., 2007; Hueb et al., 2010; Pocock et al., 1996; Pocock et al., 2000; Weintraub et al., 2008; Wijeysundera et al., 2010). (Level of Evidence: A)

Class IIa

  1. CABG or PCI to improve symptoms is reasonable in patients with 1 or more significant (≥70% diameter) coronary artery stenoses and unacceptable angina for whom GDMT cannot be implemented because of medication contraindications, adverse effects, or patient preferences. (Level of Evidence: C)
  2. PCI to improve symptoms is reasonable in patients with previous CABG, 1 or more significant (≥70% diameter) coronary artery stenoses associated with ischemia, and unacceptable angina despite GDMT (Gurfinkel et al., 2007; Pfautsch et al., 1999; Subramanian et al., 2009). (Level of Evidence: C)
  3. It is reasonable to choose CABG over PCI to improve symptoms in patients with complex 3-vessel CAD (e.g., SYNTAX score >22), with or without involvement of the proximal LAD artery who are good candidates for CABG (Hannan et al., 2008; Kappetein et al., 2011; Smith et al., 2006; Hannan et al., "Long-term," 2005). (Level of Evidence: B)

Class IIb

  1. CABG to improve symptoms might be reasonable for patients with previous CABG, 1 or more significant (≥70% diameter) coronary artery stenoses not amenable to PCI, and unacceptable angina despite GDMT (Weintraub et al., 1997). (Level of Evidence: C)
  2. Transmyocardial laser revascularization (TMR) performed as an adjunct to CABG to improve symptoms may be reasonable in patients with viable ischemic myocardium that is perfused by arteries that are not amenable to grafting (Schofield et al., 1999; Aaberge et al., 2000; Burkhoff et al., 1999; Allen et al., 2000; Stamou et al., 2002). (Level of Evidence: B)

Class III: HARM

  1. CABG or PCI to improve symptoms should not be performed in patients who do not meet anatomic (≥50% diameter left main or ≥70% non–left main stenosis diameter) or physiological (e.g., abnormal FFR) criteria for revascularization. (Level of Evidence: C)

Dual Antiplatelet Therapy (DAPT) Compliance and Stent Thrombosis

Class III: HARM

  1. PCI with coronary stenting (bare-metal stent [BMS] or drug-eluting stent [DES]) should not be performed if the patient is not likely to be able to tolerate and comply with DAPT for the appropriate duration of treatment based on the type of stent implanted (Grines et al., 2007; Leon et al., 1998; Mauri et al., "Stent," 2007; McFadden, et al., 2004). (Level of Evidence: B)

Hybrid Coronary Revascularization

Class IIa

  1. Hybrid coronary revascularization (defined as the planned combination of LIMA-to-LAD artery grafting and PCI of ≥1 non-LAD coronary arteries) is reasonable in patients with 1 or more of the following (Bonatti et al., 2008; Gilard et al., 2007; Holzhey et al., 2008; Kon et al., 2008; Reicher et al., 2008; Vassiliades et al., 2006; Zhao et al., 2009) (Level of Evidence: B):
    1. Limitations to traditional CABG, such as heavily calcified proximal aorta or poor target vessels for CABG (but amenable to PCI);
    2. Lack of suitable graft conduits;
    3. Unfavorable LAD artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion [CTO].

Class IIb

  1. Hybrid coronary revascularization (defined as the planned combination of LIMA-to-LAD artery grafting and PCI of ≥1 non-LAD coronary arteries) may be reasonable as an alternative to multivessel PCI or CABG in an attempt to improve the overall risk-benefit ratio of the procedures. (Level of Evidence: C)

Preprocedural Considerations

Radiation Safety

Class I

  1. Cardiac catheterization laboratories should routinely record relevant available patient procedural radiation dose data (e.g., total air kerma at the international reference point [Ka,r], air kerma air product [PKA], fluoroscopy time, number of cine images), and should define thresholds with corresponding follow-up protocols for patients who receive a high procedural radiation dose. (Level of Evidence: C)

Contrast-Induced Acute Kidney Injury (AKI)

Class I

  1. Patients should be assessed for risk of contrast-induced AKI before PCI (Mehran et al., 2004; Moscucci et al., 2006). (Level of Evidence: C)
  2. Patients undergoing cardiac catheterization with contrast media should receive adequate preparatory hydration (Bader et al., 2004; Mueller et al., 2002; Solomon et al., 1994; Trivedi et al., 2003). (Level of Evidence: B)
  3. In patients with chronic kidney disease (CKD) (creatinine clearance <60 mL/min), the volume of contrast media should be minimized (Marenzi et al., 2009; McCullough et al., 1997; Russo et al., 1995). (Level of Evidence: B)

Class III: NO BENEFIT

  1. Administration of N-acetyl-L-cysteine is not useful for the prevention of contrast-induced AKI (Gonzales et al., 2007; Ozcan et al., 2007; Thiele et al., 2010; Webb et al., 2004; ACT Investigators et al., 2011). (Level of Evidence: A)

Anaphylactoid Reactions

Class I

  1. Patients with prior evidence of an anaphylactoid reaction to contrast media should receive appropriate steroid and antihistamine prophylaxis before repeat contrast administration (Levine et al., 2003; Klein et al., 2009; Tramer et al., 2006; Greenberger, Patterson, & Tapio, 1985). (Level of Evidence: B)

Class III: NO BENEFIT

  1. In patients with a prior history of allergic reactions to shellfish or seafood, anaphylactoid prophylaxis for contrast reaction is not beneficial (Shehadi, 1975; Gill et al., 2009; Swoboda et al., 2002). (Level of Evidence: C)

Statin Treatment

Class IIa

  1. Administration of a high-dose statin is reasonable before PCI to reduce the risk of periprocedural MI. (Level of Evidence: A for statin-naïve patients [Briguori et al., 2004; Briguori et al., 2009; Pasceri et al., 2004; Patti et al., 2007; Yun et al., 2009; Zhang et al., 2010; Winchester et al., 2010]; Level of Evidence: B for those on chronic statin therapy [Di Sciascio et al., 2009])

PCI in Hospitals Without On-Site Surgical Backup

Class IIa

  1. Primary PCI is reasonable in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished (Aversano et al., 2002; Dehmer et al., 2007). (Level of Evidence: B)

Class IIb

  1. Elective PCI might be considered in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished and rigorous clinical and angiographic criteria are used for proper patient selection (Dehmer et al., 2007; Melberg et al., 2006; Singh et al., 2011). (Level of Evidence: B)

Class III: HARM

  1. Primary or elective PCI should not be performed in hospitals without on-site cardiac surgery capabilities without a proven plan for rapid transport to a cardiac surgery operating room in a nearby hospital or without appropriate hemodynamic support capability for transfer. (Level of Evidence: C)

Procedural Considerations

Vascular Access

Class IIa

  1. The use of radial artery access can be useful to decrease access site complications (Jolly et al., "Radial," 2009; Rao et al., 2010; Brueck et al., 2009; Jaffe et al., 2007; Louvard, et al., 2004; Pristipino et al., 2009; Rao et al., 2008; Hamon et al., 2009; Jolly et al., 2011). (Level of Evidence: A)

PCI in Specific Clinical Situations

UA/NSTEMI

Class I

  1. An early invasive strategy (i.e., diagnostic angiography with intent to perform revascularization) is indicated in UA/NSTEMI patients who have refractory angina or hemodynamic or electrical instability (without serious comorbidities or contraindications to such procedures) (Fox et al., 2010; Bavry et al., 2006; Cannon et al., 2001). (Level of Evidence: B)
  2. An early invasive strategy (i.e., diagnostic angiography with intent to perform revascularization) is indicated in initially stabilized UA/ NSTEMI patients (without serious comorbidities or contraindications to such procedures) who have an elevated risk for clinical events (Fox et al., 2010; Cannon et al., 2001; "Invasive compared with non-invasive," 1999; Mehta et al., 2009). (Level of Evidence: A)
  3. The selection of PCI or CABG as the means of revascularization in the patient with ACS should generally be based on the same considerations as those without ACS (Jones et al., 1996; Rodriguez et al., 2005; Fox et al., 2010; Valgimigli et al., 2007). (Level of Evidence: B)

Class III: NO BENEFIT

  1. An early invasive strategy (i.e., diagnostic angiography with intent to perform revascularization) is not recommended in patients with extensive comorbidities (e.g., liver or pulmonary failure, cancer) in whom (Level of Evidence: C)
    1. The risks of revascularization and comorbid conditions are likely to outweigh the benefits of revascularization, 
    2. There is a low likelihood of ACS despite acute chest pain, or
    3. Consent to revascularization will not be granted regardless of the findings.

ST-Elevation Myocardial Infarction

Coronary Angiography Strategies in STEMI

Class I

  1. A strategy of immediate coronary angiography with intent to perform PCI (or emergency CABG) in patients with STEMI is recommended for
    1. Patients who are candidates for primary PCI (Aversano et al., 2002; Keeley, Boura, & Grines, 2003; Zijlstra et al., 1993; Keeley & Grines, 2004; Keeley & Hills, 2007). (Level of Evidence: A)
    2. Patients with severe heart failure or cardiogenic shock who are suitable candidates for revascularization (Wu et al., 2002; Hochman et al., 1999). (Level of Evidence: B)

Class IIa

  1. A strategy of immediate coronary angiography (or transfer for immediate coronary angiography) with intent to perform PCI is reasonable for patients with STEMI, a moderate to large area of myocardium at risk, and evidence of failed fibrinolysis (Gershlick et al., 2005; Wijeysundera et al., 2007). (Level of Evidence: B)
  2. A strategy of coronary angiography (or transfer for coronary angiography) 3 to 24 hours after initiating fibrinolytic therapy with intent to perform PCI is reasonable for hemodynamically stable patients with STEMI and evidence for successful fibrinolysis when angiography and revascularization can be performed as soon as logistically feasible in this time frame (Bohmer et al., 2010; Di Mario et al., 2008; Fernandez-Aviles et al., 2004; Borgia et al., 2010; Cantor et al., 2009). (Level of Evidence: A)

Class IIb

  1. A strategy of coronary angiography performed before hospital discharge might be reasonable in table patients with STEMI who did not undergo cardiac catheterization within 24 hours of STEMI onset. (Level of Evidence: C)

Class III: NO BENEFIT

  1. A strategy of coronary angiography with intent to perform PCI is not recommended in patients with STEMI in whom the risks of revascularization are likely to outweigh the benefits or when the patient or designee does not want invasive care. (Level of Evidence: C)

Primary PCI of the Infarct Artery

Class I

  1. Primary PCI should be performed in patients within 12 hours of onset of STEMI (Keeley, Boura, & Grines, 2003; Zijlstra et al., 1993; Keeley & Grines, 2004; Keeley & Hills, 2007). (Level of Evidence: A)
  2. Primary PCI should be performed in patients with STEMI presenting to a hospital with PCI capability within 90 minutes of first medical contact as a systems goal (Lambert et al., 2010; Terkelsen et al., 2010). (Level of Evidence: B)
  3. Primary PCI should be performed in patients with STEMI presenting to a hospital without PCI capability within 120 minutes of first medical contact as a systems goal (Aguirre et al., 2008; Blankenship et al., 2011; Henry et al., 2007). (Level of Evidence: B)
  4. Primary PCI should be performed in patients with STEMI who develop severe heart failure or cardiogenic shock and are suitable candidates for revascularization as soon as possible, irrespective of time delay (Wu et al., 2002; Hochman et al., 1999). (Level of Evidence: B)
  5. Primary PCI should be performed as soon as possible in patients with STEMI and contraindications to fibrinolytic therapy with ischemic symptoms for less than 12 hours (Zahn et al., 1999; Grzybowski et al., 2003). (Level of Evidence: B)

Class IIa

  1. Primary PCI is reasonable in patients with STEMI if there is clinical and/or electrocardiographic evidence of ongoing ischemia between 12 and 24 hours after symptom onset ("Indications for fibrinolytic therapy," 1994; Schomig et al., 2005; Gierlotka et al., 2011). (Level of Evidence: B)

Class IIb

  1. Primary PCI might be considered in asymptomatic patients with STEMI and higher risk presenting between 12 and 24 hours after symptom onset. (Level of Evidence: C)

Class III: HARM

  1. PCI should not be performed in a noninfarct artery at the time of primary PCI in patients with STEMI without hemodynamic compromise (Toma et al., 2010; Widimsky & Holmes, 2011; Politi et al., 2010; Vlaar et al., 2011; Kornowski et al., 2011). (Level of Evidence: B)

Delayed or Elective PCI in Patients with STEMI

Class IIa

  1. PCI is reasonable in patients with STEMI and clinical evidence for fibrinolytic failure or infarct artery reocclusion (Gershlick et al., 2005; Wijeysundera et al., 2007). (Level of Evidence: B)
  2. PCI is reasonable in patients with STEMI and a patent infarct artery 3 to 24 hours after fibrinolytic therapy (Borgia et al., 2010; Cantor et al., 2009). (Level of Evidence: B)
  3. PCI is reasonable in patients with STEMI who demonstrate ischemia on noninvasive testing (Erne et al., 2007; Madsen et al., 1997). (Level of Evidence: B)

Class IIb

  1. PCI of a hemodynamically significant stenosis in a patent infarct artery greater than 24 hours after STEMI may be considered as part of an invasive strategy (Stenestrand & Wallentin, 2002; Alter et al., 2003; Zeymer et al., 2003; Gupta et al., 2003; Gibson et al., 2003). (Level of Evidence: B)

Class III: NO BENEFIT

  1. PCI of a totally occluded infarct artery greater than 24 hours after STEMI should not be performed in asymptomatic patients with 1- or 2-vessel disease if patients are hemodynamically and electrically stable and do not have evidence of severe ischemia (Ioannidis & Katritsis, 2007; Steg et al., 2004; Hochman et al., "Coronary," 2006).(Level of Evidence: B)

Cardiogenic Shock

Class I

  1. PCI is recommended for patients with acute MI who develop cardiogenic shock and are suitable candidates (Hochman et al., 1999; Hochman et al., 2001; Hochman et al., "Early," 2006; Urban et al., 1999). (Level of Evidence: B)
  2. A hemodynamic support device is recommended for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy (Hochman et al., 1999; Sanborn et al., 2000; Chen et al., 2003; Barron et al., 2001; Reynolds & Hochman, 2008). (Level of Evidence: B)

Revascularization Before Noncardiac Surgery

Class IIa

  1. For patients who require PCI and are scheduled for elective noncardiac surgery in the subsequent 12 months, a strategy of balloon angioplasty, or BMS implantation followed by 4 to 6 weeks of DAPT, is reasonable (Berger et al., 1999; Cruden et al., 2010; American College of Cardiology Foundation/American Heart Association Task Force, et al., 2009; Kaluza et al., 2000; Reddy & Vaitkus, 2005; Sharma et al., 2004; Wilson et al., 2003). (Level of Evidence: B)
  2. For patients with DES who must undergo urgent surgical procedures that mandate the discontinuation of DAPT, it is reasonable to continue aspirin if possible and restart the P2Y12 inhibitor as soon as possible in the immediate postoperative period (American College of Cardiology Foundation/American Heart Association Task Force et al., 2009). (Level of Evidence: C)

Class III: HARM

  1. Routine prophylactic coronary revascularization should not be performed in patients with stable CAD before noncardiac surgery (McFalls et al., 2004; Schouten et al., 2009). (Level of Evidence: B)
  2. Elective noncardiac surgery should not be performed in the 4 to 6 weeks after balloon angioplasty or BMS implantation or the 12 months after DES implantation in patients in whom the P2Y12 inhibitor will need to be discontinued perioperatively (Grines et al., 2007; Sharma et al., 2004; Kaluza et al., 2000; Win et al., 2007). (Level of Evidence: B)

Coronary Stents

Class I

  1. Before implantation of DES, the interventional cardiologist should discuss with the patient the need for and duration of DAPT and the ability of the patient to comply with and tolerate DAPT (Eisenstein et al., 2007). (Level of Evidence: C)
  2. DES are useful as an alternative to BMS to reduce the risk of restenosis in cases in which the risk of restenosis is increased and the patient is likely to be able to tolerate and comply with prolonged DAPT (Level of Evidence: A for elective PCI [Mauri et al., 2008; Mehilli et al., 2011; Moses et al., 2003; Stone et al., 2004; Stone et al., 2009]; Level of Evidence: C for UA/NSTEMI [Mauri et al., 2008]; Level of Evidence: A for STEMI [Mauri et al., 2008; Stone et al., 2009; Pan et al., 2010; Hao et al., 2010; Suh et al., 2011]) .
  3. Balloon angioplasty or BMS should be used in patients with high bleeding risk, inability to comply with 12 months of DAPT, or anticipated invasive or surgical procedures within the next 12 months, during which time DAPT may be interrupted (Grines et al., 2007; Park et al., 2006; Spertus et al., 2006; Nasser, Kapeliovich, & Markiewicz, 2005). (Level of Evidence: B)

Class III: HARM

  1. PCI with coronary stenting should not be performed if the patient is not likely to be able to tolerate and comply with DAPT (Grines et al., 2007; Leon et al., 1998; Mauri et al., "Stent," 2007; McFadden et al., 2004). (Level of Evidence: B)
  2. DES should not be implanted if the patient is not likely to be able to tolerate and comply with prolonged DAPT or this cannot be determined before stent implantation (Grines et al., 2007; Park et al., 2006; Spertus et al., 2006; Nasser, Kapeliovich, & Markiewicz, 2005). (Level of Evidence: B)

Adjunctive Diagnostic Devices

Fractional Flow Reserve (FFR)

Class IIa

  1. FFR is reasonable to assess angiographic intermediate coronary lesions (50% to 70% diameter stenosis) and can be useful for guiding revascularization decisions in patients with SIHD (Tonino et al., 2010; Tonino et al., 2009; Hamilos et al., 2009; Pijls et al., 2007; Pijls et al., 2010). (Level of Evidence: A)

Intravascular Ultrasound (IVUS)

Class IIa

  1. IVUS is reasonable for the assessment of angiographically indeterminant left main CAD (Briguori et al., 2001; Fassa et al., 2005; Kang et al., 2011). (Level of Evidence: B)
  2. IVUS and coronary angiography are reasonable 4 to 6 weeks and 1 year after cardiac transplantation to exclude donor CAD, detect rapidly progressive cardiac allograft vasculopathy, and provide prognostic information (Costanzo et al., 2010; Kobashigawa et al., 2005; Kapadia et al., 1998). (Level of Evidence: B)
  3. IVUS is reasonable to determine the mechanism of stent restenosis (Dangas et al., 2010). (Level of Evidence: C)

Class IIb

  1. IVUS may be reasonable for the assessment of non–left main coronary arteries with angiographically intermediate coronary stenoses (50% to 70% diameter stenosis) (Briguori et al., 2001; Takagi et al., 1999; Magni et al., 2009). (Level of Evidence: B)
  2. IVUS may be considered for guidance of coronary stent implantation, particularly in cases of left main coronary artery stenting (Fassa et al., 2005; Dangas et al., 2010; Park et al., 2009). (Level of Evidence: B)
  3. IVUS may be reasonable to determine the mechanism of stent thrombosis (Dangas et al., 2010). (Level of Evidence: C)

Class III: NO BENEFIT

  1. IVUS for routine lesion assessment is not recommended when revascularization with PCI or CABG is not being contemplated. (Level of Evidence: C)

Adjunctive Therapeutic Devices

Coronary Atherectomy

Class IIa

  1. Rotational atherectomy is reasonable for fibrotic or heavily calcified lesions that might not be crossed by a balloon catheter or adequately dilated before stent implantation (Moussa et al., 1997; Vaquerizo et al., 2010). (Level of Evidence: C)

Class III: NO BENEFIT

  1. Rotational atherectomy should not be performed routinely for de novo lesions or in-stent restenosis (Bittl et al., 2004; Mauri et al., 2003; Reifart et al., 1997; vom Dahl et al., 2002). (Level of Evidence: A)

Thrombectomy

Class IIa

  1. Aspiration thrombectomy is reasonable for patients undergoing primary PCI (Sardella et al., 2009; Vlaar et al., 2008; Bavry, Kumbhani, & Bhatt, 2008). (Level of Evidence: B)

Laser Angioplasty

Class IIb

  1. Laser angioplasty might be considered for fibrotic or moderately calcified lesions that cannot be crossed or dilated with conventional balloon angioplasty (Noble & Bilodeau, 2008). (Level of Evidence: C)

Class III: NO BENEFIT

  1. Laser angioplasty should not be used routinely during PCI (Bittl et al., 2004; Reifart et al., 1997; Stone et al., 1997). (Level of Evidence: A)

Cutting Balloon Angioplasty

Class IIb

  1. Cutting balloon angioplasty might be considered to avoid slippage-induced coronary artery trauma during PCI for in-stent restenosis or ostial lesions in side branches (Albiero et al., 2004). (Level of Evidence: C)

Class III: NO BENEFIT

  1. Cutting balloon angioplasty should not be performed routinely during PCI (Bittl et al., 2004; Albiero et al., 2004; Mauri et al., 2002). (Level of Evidence: A)

Embolic Protection Devices

Class I

  1. Embolic protection devices (EPDs) should be used during saphenous vein graft (SVG) PCI when technically feasible (Baim et al., 2002; Coolong et al., 2008; Mauri et al., 2007; Stone et al., 2003). (Level of Evidence: B)

Percutaneous Hemodynamic Support Devices

Class IIb

  1. Elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients. (Level of Evidence: C)

Interventional Pharmacotherapy

Oral Antiplatelet Therapy

Class I

  1. Patients already taking daily aspirin therapy should take 81 mg to 325 mg before PCI (Barnathan et al., 1987; Jolly et al., 2009; Popma et al., 2004; Schwartz et al., 1988). (Level of Evidence: B)
  2. Patients not on aspirin therapy should be given nonenteric aspirin 325 mg before PCI (Barnathan et al., 1987; Popma et al., 2004; Schwartz et al., 1988). (Level of Evidence: B)
  3. After PCI, use of aspirin should be continued indefinitely (Schomig et al., 1996; Antithrombotic Trialists' Collaboration, 2002; American Heart Association (AHA) et al., 2006; Antithrombotic Trialists' (ATT) Collaboration et al., 2009) (Level of Evidence: A)
  4. A loading dose of a P2Y12 receptor inhibitor should be given to patients undergoing PCI with stenting (Gurbel et al., 2005; Sabatine et al., 2005; van der Heijden et al., 2004; Wiviott et al., 2007; Wallentin et al., 2009) (Level of Evidence: A). Options include
    1. Clopidogrel 600 mg (acute coronary syndrome [ACS] and non-ACS patients) (Gurbel et al., 2005; Sabatine et al., 2005; van der Heijden et al., 2004) (Level of Evidence: B)
    2. Prasugrel 60 mg (ACS patients) (Wiviott et al., 2007) (Level of Evidence: B)
    3. Ticagrelor 180 mg (ACS patients) (Wallentin et al., 2009) (Level of Evidence: B)
  5. The loading dose of clopidogrel for patients undergoing PCI after fibrinolytic therapy should be 300 mg within 24 hours and 600 mg more than 24 hours after receiving fibrinolytic therapy (Sabatine et al., 2005; Chen et al., 2005) (Level of Evidence: C)
  6. Patients should be counseled on the need for and risks of DAPT before placement of intracoronary stents, especially DES, and alternative therapies should be pursued if patients are unwilling or unable to comply with the recommended duration of DAPT (Grines et al., 2007). (Level of Evidence: C)
  7. The duration of P2Y12 inhibitor therapy after stent implantation should generally be as follows:
    1. In patients receiving a stent (BMS or DES) during PCI for ACS, P2Y12 inhibitor therapy should be given for at least 12 months. Options include clopidogrel 75 mg daily (Mehta et al., 2001), prasugrel 10 mg daily (Wiviott et al., 2007), and ticagrelor 90 mg twice daily (Wallentin et al., 2009). (Level of Evidence: B)
    2. In patients receiving DES for a non-ACS indication, clopidogrel 75 mg daily should be given for at least 12 months if patients are not at high risk of bleeding (Grines et al., 2007; Eisenstein et al., 2007; Brar et al., 2008). (Level of Evidence: B)
    3. In patients receiving BMS for a non-ACS indication, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks) (Grines et al., 2007; Steinhubl et al., 2002). (Level of Evidence: B)

Class IIa

  1. After PCI, it is reasonable to use aspirin 81 mg per day in preference to higher maintenance doses (Jolly et al., "Effects," 2009; Patrono et al., 2008; Steinhubl et al., 2009; Serebruany et al., 2005; Peters et al., 2003). (Level of Evidence: B)
  2. If the risk of morbidity from bleeding outweighs the anticipated benefit afforded by a recommended duration of P2Y12 inhibitor therapy after stent implantation, earlier discontinuation (e.g., <12 months) of P2Y12 inhibitor therapy is reasonable. (Level of Evidence: C)

Class IIb

  1. Continuation of DAPT beyond 12 months may be considered in patients undergoing DES implantation (Wiviott et al., 2007; Wallentin et al., 2009). (Level of Evidence: C)

Class III: HARM

  1. Prasugrel should not be administered to patients with a prior history of stroke or transient ischemic attack (Wiviott et al., 2007). (Level of Evidence: B)

IV Antiplatelet Therapy

STEMI

Class IIa

  1. In patients undergoing primary PCI treated with unfractionated heparin (UFH), it is reasonable to administer a glycoprotein (GP) IIb/IIIa inhibitor (abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban), whether or not patients were pretreated with clopidogrel (Antoniucci et al., 2004; Neumann et al., 2000; Stone et al., 2002; Montalescot et al., 2001; De Luca et al., 2005; Mehilli et al., 2009; De Luca et al., "Risk," 2009). (For GP IIb/IIIa inhibitor administration in patients not pretreated with clopidogrel, Level of Evidence: A; for GP IIb/IIIa inhibitor administration in patients pretreated with clopidogrel, Level of Evidence: C)

Class IIb

  1. In patients undergoing primary PCI with abciximab, it may be reasonable to administer intracoronary abciximab (Mehilli et al., 2009; Bellandi et al., 2004; Romagnoli et al., 2005; Iversen, Galatius, & Jensen, 2008; Wohrle et al., 2008; Kakkar et al., 2004; Wohrle et al., 2003; Bertrand et al., 2010; Deibele et al., 2006; Yang et al., 2007; Deibele et al., 2010; Hansen et al., 2010; Galache Osuna et al., 2006; Wu et al., 2008; Marciniak et al., 2002). (Level of Evidence: B)

Class III: NO BENEFIT

  1. Routine precatheterization laboratory (e.g., ambulance or emergency department) administration of GP IIb/IIIa inhibitors as part of an upstream strategy for patients with STEMI undergoing PCI is not beneficial (Montalescot et al., 2004; Maioli et al., 2007; Keeley, Boura, & Grines, 2006; Van't Hof et al., 2008; ten Berg et al., 2010; Ellis et al., 2009; Ellis et al., 2008; El Khoury et al., 2010). (Level of Evidence: B)

UA/NSTEMI

Class I

  1. In UA/NSTEMI patients with high-risk features (e.g., elevated troponin level) not treated with bivalirudin and not adequately pretreated with clopidogrel, it is useful at the time of PCI to administer a GP IIb/IIIa inhibitor (abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban) in patients treated with UFH ("Platelet glycoprotein," 1997; Boersma et al., 1999; Hamm et al., 1999; Kastrati et al., 2006; Roffi et al., 2001; "Use of monoclonal," 1994). (Level of Evidence: A)

Class IIa

  1. In UA/NSTEMI patients with high-risk features (e.g., elevated troponin level) treated with UFH and adequately pretreated with clopidogrel, it is reasonable at the time of PCI to administer a GP IIb/IIIa inhibitor (abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban) (Kastrati et al., 2006; Valgimigli et al., 2004). (Level of Evidence: B)

Stable Ischemic Heart Disease

Class IIa

  1. In patients undergoing elective PCI treated with UFH and not pretreated with clopidogrel, it is reasonable to administer a GP IIb/IIIa inhibitor (abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban) (Valgimigli et al., 2004; "Randomised placebo-controlled," 1998; ESPIRIT Investigators, 2000). (Level of Evidence: B)

Class IIb

  1. In patients undergoing elective PCI with stent implantation treated with UFH and adequately pretreated with clopidogrel, it might be reasonable to administer a GP IIb/IIIa inhibitor (abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban) (Valgimigli et al., 2004; Kastrati et al., 2004; Mehilli et al., 2004; Hausleiter et al., 2004). (Level of Evidence: B)

Anticoagulant Therapy

Use of Parenteral Anticoagulants During PCI

Class I

  1. An anticoagulant should be administered to patients undergoing PCI. (Level of Evidence: C)

Unfractionated Heparin

Class I

  1. Administration of intravenous (IV) UFH is useful in patients undergoing PCI. (Level of Evidence: C)

Enoxaparin

Class I

  1. An additional dose of 0.3 mg/kg IV enoxaparin should be administered at the time of PCI to patients who have received fewer than 2 therapeutic subcutaneous doses (e.g., 1 mg/kg) or received the last subcutaneous enoxaparin dose 8 to 12 hours before PCI (Ferguson et al., 2004; Cohen et al., 2010; Collet et al., 2004; Levine & Ferrando, 2004; Martin et al., 2004). (Level of Evidence: B)

Class IIb

  1. Performance of PCI with enoxaparin may be reasonable in patients either treated with "upstream" subcutaneous enoxaparin for UA/NSTEMI or who have not received prior antithrombin therapy and are administered IV enoxaparin at the time of PCI (Brieger et al., 2011; Choussat et al., 2002; Collet et al., 2001; Ferguson et al., 2004; Montalescot et al., "Enoxaparin," 2009). (Level of Evidence: B)

Class III: HARM

  1. UFH should not be given to patients already receiving therapeutic subcutaneous enoxaparin (Ferguson et al., 2004; Drouet, Bal dit Sollier, & Martin, 2009). (Level of Evidence: B)

Bivalirudin and Argatroban

Class I

  1. For patients undergoing PCI, bivalirudin is useful as an anticoagulant with or without prior treatment with UFH (De Luca et al., 2009; Lincoff et al., 2008; Kastrati et al., 2008; Lincoff et al., 2003; Lincoff et al., 2004; Mehran et al., 2009; Schulz et al., 2010; Stone et al., 2006; Stone et al., "Bivalirudin," 2008; Dangas et al., 2009). (Level of Evidence: B)
  2. For patients with heparin-induced thrombocytopenia, it is recommended that bivalirudin or argatroban be used to replace UFH (Lewis et al., 2002; Mahaffey et al., 2003). (Level of Evidence: B)

Fondaparinux

Class III: HARM

  1. Fondaparinux should not be used as the sole anticoagulant to support PCI. An additional anticoagulant with anti-IIa activity should be administered because of the risk of catheter thrombosis (Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, 2006; Yusuf et al., 2006). (Level of Evidence: C)

No-Reflow Pharmacological Therapies

Class IIa

  1. Administration of an intracoronary vasodilator (adenosine, calcium channel blocker, or nitroprusside) is reasonable to treat PCI-related no-reflow that occurs during primary or elective PCI (Amit et al., 2006; Assali et al., 2000; Barcin et al., 2004; Fischell et al., 2008; Hillegass et al., 2001; Huang et al., 2006; Ito et al., 1999; Kaplan et al., 1996; Marzilli et al., 2000; Ono et al., 2004; Piana et al., 1994; Ross et al., 2005; Sdringola et al., 2000; Stoel et al., 2008; Werner et al., 2002; Weyrens et al., 1995). (Level of Evidence: B)

PCI in Specific Anatomic Situations

Chronic Total Occlusion

Class IIa

  1. PCI of a CTO in patients with appropriate clinical indications and suitable anatomy is reasonable when performed by operators with appropriate expertise (Olivari et al., 2003; Suero et al., 2001; de Labriolle et al., 2008; Rathore et al., 2009; Stone et al., 2005). (Level of Evidence: B)

Saphenous Vein Grafts

Class I

  1. Embolic protection devices (EPDs) should be used during saphenous vein grafts (SVGs) PCI when technically feasible (Baim et al., 2002; Coolong et al., 2008; Mauri et al., 2007; Stone et al., 2003). (Level of Evidence: B)

Class III: NO BENEFIT

  1. Platelet GP IIb/IIIa inhibitors are not beneficial as adjunctive therapy during SVG PCI (Eisenstein et al., 2007; Brar et al., 2008; Roffi et al., 2002; Ellis et al., 1998). (Level of Evidence: B)

Class III: HARM

  1. PCI is not recommended for chronic SVG occlusions (Al-Lamee et al., 2010; de Feyter et al., 1989; de Feyter et al., 1993). (Level of Evidence: C)

Bifurcation Lesions

Class I

  1. Provisional side-branch stenting should be the initial approach in patients with bifurcation lesions when the side branch is not large and has only mild or moderate focal disease at the ostium (Colombo et al., 2009; Ferenc et al., 2008; Hildick-Smith et al., 2010; Steigen et al., 2006). (Level of Evidence: A)

Class IIa

  1. It is reasonable to use elective double stenting in patients with complex bifurcation morphology involving a large side branch where the risk of side-branch occlusion is high and the likelihood of successful side-branch reaccess is low (Chen et al., 2011; Moussa 2011; Aliabadi et al., 1997; Galassi et al., 2009). (Level of Evidence: B)

Aorto-Ostial Stenoses

Class IIa

  1. IVUS is reasonable for the assessment of angiographically indeterminant left main CAD (Gil et al., 2005; Sano et al., 2007). (Level of Evidence: B)
  2. Use of DES is reasonable when PCI is indicated in patients with an aorto-ostial stenosis (Park et al., 2007; Iakovou et al., 2004). (Level of Evidence: B)

Calcified Lesions

Class IIa

  1. Rotational atherectomy is reasonable for fibrotic or heavily calcified lesions that might not be crossed by a balloon catheter or adequately dilated before stent implantation (Moussa et al., 1997; Vaquerizo et al., 2010; Brogan et al., 1993). (Level of Evidence: C)

PCI in Specific Patient Populations

Chronic Kidney Disease

Class I

  1. In patients undergoing PCI, the glomerular filtration rate should be estimated and the dosage of renally cleared medications should be adjusted (Levey et al., 2006; Stevens et al., 2009; Hassan et al., 2009). (Level of Evidence: B)

Periprocedural MI Assessment

Class I

  1. In patients who have signs or symptoms suggestive of MI during or after PCI or in asymptomatic patients with significant persistent angiographic complications (e.g., large side-branch occlusion, flow-limiting dissection, no-reflow phenomenon, or coronary thrombosis), creatinine kinase-MB and troponin I or T should be measured. (Level of Evidence: C)

Class IIb

  1. Routine measurement of cardiac biomarkers (creatinine kinase-MB and/or troponin I or T) in all patients after PCI may be reasonable. (Level of Evidence: C)

Vascular Closure Devices

Class I

  1. Patients considered for vascular closure devices should undergo a femoral angiogram to ensure their anatomic suitability for deployment. (Level of Evidence: C)

Class IIa

  1. The use of vascular closure devices is reasonable for the purposes of achieving faster hemostasis and earlier ambulation compared with the use of manual compression (Patel et al., 2010; Biancari et al., 2010; Dauerman, Applegate, & Cohen, 2007; Koreny et al., 2004). (Level of Evidence: B)

Class III: NO BENEFIT

  1. The routine use of vascular closure devices is not recommended for the purpose of decreasing vascular complications, including bleeding (Nikolsky et al., 2004; Patel et al., 2010; Biancari et al., 2010; Dauerman, Applegate, & Cohen, 2007; Koreny et al., 2004; Hoffer & Bloch, 2003). (Level of Evidence: B)

Postprocedural Considerations

Postprocedural considerations in patients undergoing PCI are discussed below and summarized in Table 14 in the original guideline document. Some recommendations and text regarding DAPT in Section 5.7.2 in the original guideline document are intentionally repeated in this section for reader ease of use.

Postprocedural Antiplatelet Therapy

Class I

  1. After PCI, use of aspirin should be continued indefinitely (Schomig et al., 1996; Antithrombotic Trialists' Collaboration, 2002; AHA et al., 2006; ATT Collaboration et al., 2009). (Level of Evidence: A)
  2. The duration of P2Y12 inhibitor therapy after stent implantation should generally be as follows:
    1. In patients receiving a stent (BMS or DES) during PCI for ACS, P2Y12 inhibitor therapy should be given for at least 12 months. Options include clopidogrel 75 mg daily (Mehta et al., 2001), prasugrel 10 mg daily (Wiviott, et al., 2007), and ticagrelor 90 mg twice daily (Wallentin et al., 2009). (Level of Evidence: B)
    2. In patients receiving DES for a non-ACS indication, clopidogrel 75 mg daily should be given for at least 12 months if the patient is not at high risk of bleeding (Grines et al., 2007; Eisenstein et al., 2007; Brar et al., 2008). (Level of Evidence: B)
    3. In patients receiving BMS for a non-ACS indication, clopidogrel should be given for a minimum of 1 month and ideally up to 12 months (unless the patient is at increased risk of bleeding; then it should be given for a minimum of 2 weeks) (Steinhubl et al., 2002). (Level of Evidence: B)
  3. Patients should be counseled on the importance of compliance with DAPT and that therapy should not be discontinued before discussion with their cardiologist (Grines et al., 2007). (Level of Evidence: C)

Class IIa

  1. After PCI, it is reasonable to use aspirin 81 mg per day in preference to higher maintenance doses (Jolly et al., "Effects," 2009; Patrono et al., 2008; Steinhubl et al., 2009; Serebruany et al., 2005; Peters et al., 2003). (Level of Evidence: B)
  2. If the risk of morbidity from bleeding outweighs the anticipated benefit afforded by a recommended duration of P2Y12 inhibitor therapy after stent implantation, earlier discontinuation (e.g., 12 months) of P2Y12 inhibitor therapy is reasonable. (Level of Evidence: C)

Class IIb

  1. Continuation of clopidogrel, prasugrel, or ticagrelor beyond 12 months may be considered in patients undergoing placement of DES (Wiviott et al., 2007; Wallentin et al., 2009). (Level of Evidence: C)

Proton Pump Inhibitors (PPIs) and Antiplatelet Therapy

Class I

  1. PPIs should be used in patients with a history of prior gastrointestinal (GI) bleeding who require DAPT (Abraham et al., 2010). (Level of Evidence: C)

Class IIa

  1. Use of PPIs is reasonable in patients with an increased risk of GI bleeding (e.g., advanced age, concomitant use of warfarin, steroids, nonsteroidal anti-inflammatory drugs, Helicobacter pylori infection) who require DAPT (Abraham et al., 2010). (Level of Evidence: C)

Class III: NO BENEFIT

  1. Routine use of a PPI is not recommended for patients at low risk of GI bleeding, who have much less potential to benefit from prophylactic therapy (Abraham et al., 2010). (Level of Evidence: C)

Clopidogrel Genetic Testing

Class IIb

  1. Genetic testing might be considered to identify whether a patient at high risk for poor clinical outcomes is predisposed to inadequate platelet inhibition with clopidogrel (Holmes et al., 2010). (Level of Evidence: C)
  2. When a patient predisposed to inadequate platelet inhibition with clopidogrel is identified by genetic testing, treatment with an alternate P2Y 12 inhibitor (e.g., prasugrel or ticagrelor) might be considered (Holmes et al., 2010). (Level of Evidence: C)

Class III: NO BENEFIT

  1. The routine clinical use of genetic testing to screen patients treated with clopidogrel who are undergoing PCI is not recommended (Holmes et al., 2010). (Level of Evidence: C)

Platelet Function Testing

Class IIb

  1. Platelet function testing may be considered in patients at high risk for poor clinical outcomes (Holmes et al., 2010). (Level of Evidence: C)
  2. In patients treated with clopidogrel with high platelet reactivity, alternative agents, such as prasugrel or ticagrelor, might be considered (Holmes et al., 2010). (Level of Evidence: C)

Class III: NO BENEFIT

  1. The routine clinical use of platelet function testing to screen patients treated with clopidogrel who are undergoing PCI is not recommended (Holmes et al., 2010). (Level of Evidence: C)

Restenosis

Class I

  1. Patients who develop clinical restenosis after balloon angioplasty should be treated with BMS or DES if anatomic factors are appropriate and if the patient is able to comply with and tolerate DAPT (Erbel et al., 1998). (Level of Evidence: B)
  2. Patients who develop clinical restenosis after BMS should be treated with DES if anatomic factors are appropriate and the patient is able to comply with and tolerate DAPT (Dibra et al., 2007; Holmes et al., 2006; Kastrati et al., 2005). (Level of Evidence: A)

Class IIa

  1. IVUS is reasonable to determine the mechanism of stent restenosis (Dangas et al., 2010). (Level of Evidence: C)

Class IIb

  1. Patients who develop clinical restenosis after DES may be considered for repeat PCI with balloon angioplasty, BMS, or DES containing the same drug or an alternative antiproliferative drug if anatomic factors are appropriate and the patient is able to comply with and tolerate DAPT (Dangas et al., 2010). (Level of Evidence: C)

Clinical Follow-up

Exercise Testing

Class IIa

  1. In patients entering a formal cardiac rehabilitation program after PCI, treadmill exercise testing is reasonable. (Level of Evidence: C)

Class III: NO BENEFIT

  1. Routine periodic stress testing of asymptomatic patients after PCI without specific clinical indications should not be performed (Eisenberg et al., 2004). (Level of Evidence: C)

Cardiac Rehabilitation

Class I

  1. Medically supervised exercise programs (cardiac rehabilitation) should be recommended to patients after PCI, particularly for moderate- to high-risk patients for whom supervised exercise training is warranted (Goel et al., 2011; Taylor et al., 2004; Giannuzzi et al., 2008; Witt et al., 2004; Fletcher et al., 2001; Thompson, 2003; Clark et al., 2005; Thomas et al., 2007; Walther et al., 2008). (Level of Evidence: A)

Secondary Prevention

The treatment of the patient does not end with PCI; secondary prevention measures are a critical component of patient management. Important secondary prevention measures were presented in detail in the '2006 AHA/ACC Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease' (AHA et al., 2006) and have recently been updated in the 'AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 Update' (Smith et al., 2011). The reader is referred to this document for detailed discussions of secondary prevention.

Quality and Performance Considerations

Quality and Performance

Class I

  1. Every PCI program should operate a quality-improvement program that routinely 1) reviews quality and outcomes of the entire program; 2) reviews results of individual operators; 3) includes risk adjustment; 4) provides peer review of difficult or complicated cases; and 5) performs random case reviews. (Level of Evidence: C)
  2. Every PCI program should participate in a regional or national PCI registry for the purpose of benchmarking its outcomes against current national norms. (Level of Evidence: C)

Certification and Maintenance of Certification

Class IIa

  1. It is reasonable for all physicians who perform PCI to participate in the American Board of Internal Medicine interventional cardiology board certification and maintenance of certification program. (Level of Evidence: C)

Operator and Institutional Competency and Volume

Class I

  1. Elective/urgent PCI should be performed by operators with an acceptable annual volume (≥75 procedures) at high-volume centers (>400 procedures) with on-site cardiac surgery (Hannan et al., "Volume," 2005; Post et al., 2010). (Level of Evidence: C)
  2. Elective/urgent PCI should be performed by operators and institutions whose current risk-adjusted outcomes statistics are comparable to those reported in contemporary national data registries. (Level of Evidence: C)
  3. Primary PCI for STEMI should be performed by experienced operators who perform more than 75 elective PCI procedures per year and, ideally, at least 11 PCI procedures for STEMI per year. Ideally, these procedures should be performed in institutions that perform more than 400 elective PCIs per year and more than 36 primary PCI procedures for STEMI per year (Hannan et al., "Volume," 2005; Cannon et al., 2000; Canto et al., 2000; Srinivas et al., 2009; Vakili, Kaplan, & Brown, 2001). (Level of Evidence: C)

Class IIa

  1. It is reasonable that operators with acceptable volume (≥75 PCI procedures per year) perform elective/urgent PCI at low-volume centers (200 to 400 PCI procedures per year) with on-site cardiac surgery (Hannan et al., "Volume," 2005). (Level of Evidence: C)
  2. It is reasonable that low-volume operators (<75 PCI procedures per year) perform elective/urgent PCI at high-volume centers (>400 PCI procedures per year) with on-site cardiac surgery. Ideally, operators with an annual procedure volume of fewer than 75 procedures per year should only work at institutions with an activity level of more than 600 procedures per year. Operators who perform fewer than 75 procedures per year should develop a defined mentoring relationship with a highly experienced operator who has an annual procedural volume of at least 150 procedures per year. (Level of Evidence: C)

Class IIb

  1. The benefit of primary PCI for STEMI patients eligible for fibrinolysis when performed by an operator who performs fewer than 75 procedures per year (<11 PCIs for STEMI per year) is not well established. (Level of Evidence: C)

Class III: NO BENEFIT

  1. It is not recommended that elective/urgent PCI be performed by low-volume operators (<75 procedures per year) at low-volume centers (200 to 400 procedures per year) with or without on-site cardiac surgery. An institution with a volume of fewer than 200 procedures per year, unless in a region that is underserved because of geography, should carefully consider whether it should continue to offer this service (Hannan et al., "Volume," 2005). (Level of Evidence: C)

Definitions:

Applying Classification of Recommendations and Level of Evidence

  Size of Treatment Effect
  CLASS I

Benefit >>> Risk

Procedure/Treatment
SHOULD be performed/administered
CLASS IIa

Benefit >> Risk
Additional studies with focused objectives needed


IT IS REASONABLE to perform procedure/administer treatment
CLASS IIb

Benefit ≥ Risk
Additional studies with broad objectives needed; additional registry data would be helpful


Procedure/Treatment
MAY BE CONSIDERED
CLASS III No Benefit
or Class III Harm
  Procedure/Test Treatment
COR III:
No Benefit
Not helpful No proven benefit
COR III:
Harm
Excess Cost without Benefit or Harmful Harmful to Patients
Estimate of Certainty (Precision) of Treatment Effect LEVEL A

Multiple populations evaluated*

Data derived from multiple randomized clinical trials or meta-analyses
  • Recommendation that procedure or treatment is useful/effective
  • Sufficient evidence from multiple randomized trials or meta-analyses
  • Recommendation in favor of treatment or procedure being useful/effective
  • Some conflicting evidence from multiple randomized trials or meta-analyses
  • Recommendation's usefulness/efficacy less well established
  • Greater conflicting evidence from multiple randomized trials or meta-analyses
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Sufficient evidence from multiple randomized trials or meta-analyses
LEVEL B

Limited populations evaluated*

Data derived from a single randomized clinical trials or nonrandomized studies
  • Recommendation that procedure or treatment is useful/effective
  • Evidence from single randomized trial or nonrandomized studies
  • Recommendation in favor of treatment or procedure being useful/effective
  • Some conflicting evidence from single randomized trial or nonrandomized studies
  • Recommendation's usefulness/efficacy less well established
  • Greater conflicting evidence from single randomized trial or nonrandomized studies
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Evidence from single randomized trial or nonrandomized studies
LEVEL C

Very limited populations evaluated*

Only consensus opinion of experts, case studies or standard of care
  • Recommendation that procedure or treatment is useful/effective
  • Only expert opinion, case studies, or standard of care
  • Recommendation in favor of treatment or procedure being useful/effective
  • Only diverging expert opinion, case studies, or standard of care
  • Recommendation's usefulness/efficacy less well established
  • Only diverging expert opinion, case studies, or standard of care
  • Recommendation that procedure or treatment is not useful/effective and may be harmful
  • Only expert opinion, case studies, or standard-of-care

A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.

*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

The recommendations listed in the original guideline document are, whenever possible, evidence based.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • The safe, appropriate, and efficacious performance of percutaneous coronary interventions in the treatment of patients with coronary artery disease
  • When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve the quality of care, optimize patient outcomes, and favorably affect costs by focusing resources on the most effective strategies.
Potential Harms
  • Factors associated with an increased risk of percutaneous coronary intervention (PCI)-related death include advanced age, comorbidities (e.g., diabetes, chronic kidney disease [CKD], congestive heart failure), multivessel coronary artery disease (CAD), high-risk lesions, and the setting of PCI (e.g., ST segment elevation myocardial infarction [STEMI], urgent or emergency procedure, cardiogenic shock).
  • Causes of procedural and periprocedural myocardial infarction (MI) include acute artery closure, embolization and no-reflow, side branch occlusion, and acute stent thrombosis.
  • Periprocedural complications of PCI (e.g., death, MI, stroke, infection, renal failure) is increased in patients with chronic kidney disease compared with those without renal dysfunction.
  • Factors associated with an increased risk of stroke include fibrinolytic therapy administered before PCI, known cerebrovascular disease, STEMI as the indication for PCI, use of an intra-aortic balloon pump (IABP), older age, and female sex.
  • Vascular complications from PCI are primarily related to vascular access. Important femoral vascular complications include access site hematoma, retroperitoneal hematoma, pseudoaneurysm, arteriovenous fistula, and arterial dissection and/or occlusion
  • Adverse radiation effects are now well recognized as infrequent but potentially serious complications of prolonged interventional procedures. Appendix 4C in the original guideline document summarizes strategies to minimize patient and operator radiation exposure.
  • The incidence of anaphylactoid reactions to contrast media is ≤1%, and the incidence of severe reactions may be as low as 0.04%. Patients with prior evidence of an anaphylactoid reaction to contrast media should receive appropriate steroid and antihistamine prophylaxis before repeat contrast administration.
  • Periprocedural bleeding is now recognized as a major risk factor for subsequent mortality. All patients should be evaluated for risk of bleeding before PCI.
  • Infrequent to rare complications occurring with the radial artery approach to PCI include compartment syndrome, pseudoaneurysm (<0.01%), and sterile abscess (occurring with previous generation hydrophilic sheaths). Radial artery spasm may occur and treatment at times may be challenging. Local hematomas may occur from small-branch vessel hydrophilic wire perforation or inexperience with wristband use.
  • The need for use of long-term warfarin and the associated increased risk of bleeding with long-term "triple therapy" is a consideration in deciding on drug-eluting stent versus bare-metal stent.

Qualifying Statements

Qualifying Statements
  • The American College of Cardiology Foundation/American Heart Association practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise for which deviations from these guidelines may be appropriate. Clinical decision making should involve consideration of the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care.
  • The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate. Prescribed courses of treatment in accordance with these recommendations are effective only if followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and be involved in shared decision making whenever feasible, particularly for class of recommendation (COR) IIa and IIb, where the benefit-to-risk ratio may be lower.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Pocket Guide/Reference Cards
Quick Reference Guides/Physician Guides
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
American College of Cardiology Foundation, American Heart Association Task Force on Practice Guidelines, Society for Cardiovascular Angiography and Interventions, Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44–122. [879 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2001 Jun (revised 2011 Dec 6)
Guideline Developer(s)
American College of Cardiology Foundation - Medical Specialty Society
American Heart Association - Professional Association
Society for Cardiovascular Angiography and Interventions - Medical Specialty Society
Source(s) of Funding

The work of the writing committee was supported exclusively by the American College of Cardiology Foundation, American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) without commercial support.

Guideline Committee

American College of Cardiology/American Heart Association Task Force on Practice Guidelines

Composition of Group That Authored the Guideline

Writing Committee Members: Glenn N. Levine, MD, FACC, FAHA (Chair); Eric R. Bates, MD, FACC, FAHA (Vice Chair); James C. Blankenship, MD, FACC, FSCAI (Vice Chair); Steven R. Bailey, MD, FACC, FSCAI; John A. Bittl, MD, FACC; Bojan Cercek, MD, FACC, FAHA; Charles E. Chambers, MD, FACC, FSCAI; Stephen G. Ellis, MD, FACC; Robert A. Guyton, MD, FACC; Steven M. Hollenberg, MD, FACC; Umesh N. Khot, MD, FACC; Richard A. Lange, MD, FACC, FAHA; Laura Mauri, MD, MSC, FACC, FSCAI; Roxana Mehran, MD, FACC, FAHA, FSCAI; Issam D. Moussa, MD, FACC, FAHA, FSCAI; Debabrata Mukherjee, MD, FACC, FSCAI; Brahmajee K. Nallamothu, MD, FACC; Henry H. Ting, MD, FACC, FAHA

American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force Members: Alice K. Jacobs, MD, FACC, FAHA (Chair); Jeffrey L. Anderson, MD, FACC, FAHA (Chair-Elect); Nancy Albert, PHD, CCNS, CCRN, FAHA; Mark A. Creager, MD, FACC, FAHA; Steven M. Ettinger, MD, FACC; Robert A. Guyton, MD, FACC; Jonathan L. Halperin, MD, FACC, FAHA; Judith S. Hochman, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; E. Magnus Ohman, MD, FACC; William Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHA

Financial Disclosures/Conflicts of Interest

The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing committee. All writing committee members and peer reviewers of the guideline are asked to disclose all such current relationships, as well as those existing 12 months previously. In December 2009, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) implemented a new policy for relationships with industry and other entities (RWI) that requires the writing committee chair plus a minimum of 50% of the writing committee to have no relevant RWI (see Appendix 1 in the original guideline document for the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing committee and are updated as changes occur. All guideline recommendations require a confidential vote by the writing committee and must be approved by a consensus of the voting members. Members are not permitted to write, and must recuse themselves from voting on, any recommendation or section to which their RWI apply.

See Appendices 1 and 2 in the original guideline document for complete lists author and reviewer relationships with industry.

Guideline Status

This is the current release of the guideline.

This guideline updates previous versions:

King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O'Neill WW, Schaff HV, Whitlow PL, ACC/AHA/SCAI, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol 2008 Jan 15;51(2):172-209.

Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Assoc Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to update the 2001 guidelines for PCI). Bethesda (MD): American College of Cardiology Foundation (ACCF); 2005. 122 p.

Guideline Availability

Electronic copies: Available to subscribers from the Journal of the American College of Cardiology Web site External Web Site Policy and the Circulation Web site External Web Site Policy.

Print copies: Available from the ACC, 2400 N Street NW, Washington DC, 20037; (800) 253-4636 (US only).

Availability of Companion Documents

The following are available:

  • Levine GN, Bates ER, et al. 2011 ACCF/AHA guideline for percutaneous coronary intervention: executive summary. Bethesda (MD): American College of Cardiology/American Heart Association. 2011. 37 p. Electronic copies: Available in Portable Document Format (PDF) from the Journal of the American College of Cardiology (JACC) Web site External Web Site Policy.
  • ACCF/AHA pocket guideline. Management of patients undergoing coronary artery revascularization. Bethesda (MD): American College of Cardiology/American Heart Association. 2011 Nov. 37 p. Electronic copies: Available in PDF from the JACC Web site External Web Site Policy.
  • 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. Slide set. Bethesda (MD): American College of Cardiology/American Heart Association. 2011. 133 p. Electronic copies: Available from the JACC Web site External Web Site Policy.
  • Methodology manual and policies from the ACCF/AHA Task Force on Practice Guidelines. 2010 Jun. 88 p. American College of Cardiology Foundation and American Heart Association, Inc. Electronic copies: Available in PDF from the American College of Cardiology (ACC) Web site External Web Site Policy.

Print copies: Available from the ACC, 2400 N Street NW, Washington DC, 20037; (800) 253-4636 (US only).

Patient Resources

None available

NGC Status

This summary was completed by ECRI on October 17, 2001. The information was verified by the guideline developer on January 18, 2002. This summary was updated by ECRI on January 13, 2006. The updated information was verified by the guideline developer on March 22, 2006. This summary was updated by ECRI on March 6, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin sodium). This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on July 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Troponin-1 Immunoassay. This summary was updated by ECRI Institute on September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin). This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This NGC summary was updated by ECRI Institute on March 25, 2008. The updated information was verified by the guideline developer on August 4, 2008. This summary was updated by ECRI Institute on December 26, 2008 following the FDA advisory on Innohep (tinzaparin). This summary was updated by ECRI Institute on January 5, 2010 following the U.S. Food and Drug Administration advisory on Plavix (Clopidogrel). This summary was updated by ECRI Institute on May 17, 2010 following the U.S. Food and Drug Administration advisory on Plavix (clopidogrel). This summary was updated by ECRI Institute on July 27, 2010 following the FDA drug safety communication on Heparin. This NGC summary was updated by ECRI Institute on April 18, 2012. The information was verified by the guideline developer on May 16, 2012. This summary was updated by ECRI Institute on August 13, 2012 following the FDA advisories on Statin drugs and Statins and HIV or Hepatitis C drugs. This summary was updated by ECRI Institute on March 10, 2014 following the U.S. Food and Drug Administration advisory on Low Molecular Weight Heparins.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions as follows:

Copyright to the original guideline is owned by the American College of Cardiology Foundation (ACCF) and the American Heart Association, Inc. (AHA). NGC users are free to download a single copy for personal use. Reproduction without permission of the ACC/AHA guidelines is prohibited. Permissions requests should be directed to copyright_permissions@acc.org.

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