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Brief Summary

GUIDELINE TITLE

ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines). A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty).

Go to the Complete Summary:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=2840&nbr=002066&string=coronary+AND+angioplasty

BIBLIOGRAPHIC SOURCE(S)

Smith SC, Dove JT, Jacobs AK, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines). J Am Coll Cardiol 2001 Jun;37(8):2239i-2239lxvi . [629 references]

GUIDELINE STATUS

This is the current release of the guideline. This guideline revises a previously issued version (Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures. J Am Coll Cardiol 1993;22:2033-54).

These guidelines will be reviewed 1 year after publication and yearly thereafter and are considered current unless the Task Force updates or withdraws them from distribution.

BRIEF SUMMARY CONTENT

RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
IDENTIFYING INFORMATION AND AVAILABILITY

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Excerpted by the National Guideline Clearinghouse (NGC)

Levels of recommendation (I-III) and strengths of evidence (A-C) are defined at the end of the Major Recommendation field.

Recommendations for Percutaneous Coronary Intervention Institutional and Operator Volumes at Centers With Onsite Cardiac Surgery

Class I

Percutaneous coronary intervention done by operators with acceptable volume (>75) at high-volume centers (>400). (Level of Evidence: B)

Class IIa

Percutaneous coronary intervention done by operators with acceptable volume (>75) at low-volume centers (200-400). (Level of Evidence: C)
Percutaneous coronary intervention done by low-volume operators (<75) at high-volume centers (>400). Note: Ideally operators with an annual procedure volume <75 should only work at institutions with an activity level of >600 procedures/year.* (Level of Evidence: C)

Class III

Percutaneous coronary intervention done by low-volume operators (<75) at low-volume centers (200-400). Note: An institution with a volume <200 procedures/year, unless in a region that is underserved because of geography, should carefully consider whether it should continue to offer service.* (Level of Evidence: C)

*Operators who perform <75 procedures/year should develop a defined mentoring relationship with a highly experienced operator who has an annual procedural volume >150 procedures/year.

Recommendations for Percutaneous Coronary Intervention With and Without On-Site Cardiac Surgery

Class I

Patients undergoing elective percutaneous coronary intervention in facilities with on-site cardiac surgery. (Level of Evidence: B)
Patients undergoing primary percutaneous coronary intervention in facilities with on-site cardiac surgery. (Level of Evidence: B)

Class IIb

Patients undergoing primary percutaneous coronary intervention in facilities without on-site cardiac surgery, but with a proven plan for rapid access (within 1 hour) to a cardiac surgery operating room in a nearby facility with appropriate hemodynamic support capability for transfer. The procedure should be limited to patients with ST-segment elevation myocardial infarction or new left bundle branch block on electrocardiograph, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (>75 percutaneous coronary interventions/year) and only at facilities performing a minimum of 36 primary percutaneous coronary intervention procedures per year. (Level of Evidence: B)

Class III

Patients undergoing elective percutaneous coronary intervention in facilities without on-site cardiac surgery. (Level of Evidence: C)
Patients undergoing primary percutaneous coronary intervention in facilities without on-site cardiac surgery and without a proven plan for rapid access (within 1 hour) to a cardiac surgery operating room in a nearby facility with appropriate hemodynamic support capability for transfer or when performed by lower skilled operators (<75 percutaneous coronary interventions per year) in a facility performing <36 primary percutaneous coronary intervention procedures per year. (Level of Evidence: C)

Recommendations for Percutaneous Coronary Intervention in Asymptomatic or Class I Angina Patients

Class I

Patients who do not have treated diabetes with asymptomatic ischemia or mild angina with 1 or more significant lesions in 1 or 2 coronary arteries suitable for percutaneous coronary intervention with a high likelihood of success and a low risk of morbidity and mortality. The vessels to be dilated must subtend a large area of viable myocardium. (Level of Evidence: B)

Class IIa

The same clinical and anatomic requirements for Class I, except the myocardial area at risk is of moderate size or the patient has treated diabetes. (Level of Evidence: B)

Class IIb

Patients with asymptomatic ischemia or mild angina with >3 coronary arteries suitable for percutaneous coronary intervention with a high likelihood of success and a low risk of morbidity and mortality. The vessels to be dilated must subtend at least a moderate area of viable myocardium. In the physician’s judgment, there should be evidence of myocardial ischemia by electrocardiograph exercise testing, stress nuclear imaging, stress echocardiography or ambulatory electrocardiograph monitoring or intracoronary physiologic measurements. (Level of Evidence: B)

Class III

Patients with asymptomatic ischemia or mild angina who do not meet the criteria as listed under Class I or Class II and who have:

Only a small area of viable myocardium at risk
No objective evidence of ischemia
Lesions that have a low likelihood of successful dilatation
Mild symptoms that are unlikely to be due to myocardial ischemia
Factors associated with increased risk of morbidity or mortality
Left main disease
Insignificant disease <50% (Level of Evidence: C)

Recommendations for Patients with Moderate or Severe Symptoms (Angina Class II to IV, Unstable Angina or Non-ST-Elevation Myocardial Infarction) With Single- or Multivessel Coronary Disease on Medical Therapy

Class I

Patients with 1 or more significant lesions in 1 or more coronary arteries suitable for percutaneous coronary intervention with a high likelihood of success and low risk of morbidity or mortality. The vessel(s) to be dilated must subtend a moderate or large area of viable myocardium and have high risk. (Level of Evidence: B)

Class IIa

Patients with focal saphenous vein graft lesions or multiple stenoses who are poor candidates for reoperative surgery. (Level of Evidence: C)

Class IIb

Patient has 1 or more lesions to be dilated with reduced likelihood of success or the vessel(s) subtend a less than moderate area of viable myocardium. Patients with 2- or 3-vessel disease, with significant proximal left anterior descending coronary artery disease and treated diabetes or abnormal left ventricular function. (Level of Evidence: B)

Class III

Patient has no evidence of myocardial injury or ischemia on objective testing and has not had a trial of medical therapy, or has

Only a small area of myocardium at risk
All lesions or the culprit lesion to be dilated with morphology with a low likelihood of success
A high risk of procedure-related morbidity or mortality. (Level of Evidence: C)

Patients with insignificant coronary stenosis (e.g., <50% diameter). (Level of Evidence: C)
Patients with significant left main coronary artery disease who are candidates for coronary artery bypass graft. (Level of Evidence: B)

Recommendations for Primary Percutaneous Coronary Intervention for Acute Transmural Myocardial Infarction Patients as an Alternative to Thrombolysis

Class I

As an alternative to thrombolytic therapy in patients with acute myocardial infarction and ST-segment elevation or new or presumed new left bundle branch block who can undergo angioplasty of the infarct artery <12 hours from the onset of ischemic symptoms or >12 hours if symptoms persist, if performed in a timely fashion* by individuals skilled in the procedure# and supported by experienced personnel in an appropriate laboratory environment.** (Level of Evidence: A)
In patients who are within 36 hours of an acute ST elevation/Q-wave or new left bundle branch block myocardial infarction who develop cardiogenic shock, are <75 years of age, and revascularization can be performed within 18 hours of the onset of shock by individuals skilled in the procedure# and supported by experienced personnel in an appropriate laboratory environment. ** (Level of Evidence: A)

* Performance standard: balloon inflation within 90 ± 30 min of hospital admission.
# Individuals who perform >75 percutaneous coronary intervention procedures per year.
** Centers that perform >200 percutaneous coronary intervention procedures per year and have cardiac surgical capability.

Class IIa

As a reperfusion strategy in candidates who have a contraindication to thrombolytic therapy. (Level of Evidence: C)

Class III

Elective percutaneous coronary intervention of a non-infarct-related artery at the time of acute myocardial infarction. (Level of Evidence: C)
In patients with acute myocardial infarction who:

have received fibrinolytic therapy within 12 hours and have no symptoms of myocardial ischemia
are eligible for thrombolytic therapy and are undergoing primary angioplasty by an inexperienced operator (individual who performs <75 percutaneous coronary intervention procedures per year)
are beyond 12 hours after onset of symptoms and have no evidence of myocardial ischemia. (Level of Evidence: C)

Recommendations for Percutaneous Coronary Intervention After Thrombolysis

Class I

Objective evidence for recurrent infarction or ischemia (rescue percutaneous coronary intervention). (Level of Evidence: B)

Class IIa

Cardiogenic shock or hemodynamic instability. (Level of Evidence: B)

Class IIb

Recurrent angina without objective evidence of ischemia/infarction. (Level of Evidence: C)
Angioplasty of the infarct-related artery stenosis within hours to days (48 hours) following successful thrombolytic therapy in asymptomatic patients without clinical and/or inducible evidence of ischemia. (Level of Evidence: B)

Class III

Routine percutaneous coronary intervention within 48 hours following failed thrombolysis. (Level of Evidence: B)
Routine percutaneous coronary intervention of the infarct-artery stenosis immediately after thrombolytic therapy. (Level of Evidence: A)

Recommendations for Percutaneous Coronary Intervention During Subsequent Hospital Management After Acute Therapy for Acute Myocardial Infarction Including Primary Percutaneous Coronary Intervention

Class I

Spontaneous or provocable myocardial ischemia during recovery from infarction. (Level of Evidence: C)
Persistent hemodynamic instability. (Level of Evidence: C)

Class IIa

Patients with left ventricular ejection fraction <0.4, congestive heart failure, or serious ventricular arrhythmias. (Level of Evidence: C)

Class IIb

Coronary angiography and angioplasty for an occluded infarct-related artery in an otherwise stable patient to revascularize that artery (open artery hypothesis). (Level of Evidence: C)
All patients after a non-Q-wave myocardial infarction. (Level of Evidence: C)
Clinical heart failure during the acute episode, but subsequent demonstration of preserved left ventricular function (left ventricular ejection fraction >0.4). (Level of Evidence: C)

Class III

Percutaneous coronary intervention of the infarct-related artery within 48 to 72 hours after thrombolytic therapy without evidence of spontaneous or provocable ischemia. (Level of Evidence: C)

Recommendations for Percutaneous Coronary Intervention With Prior Coronary Artery Bypass Graft

Class I

Patients with early ischemia (usually within 30 days) after coronary artery bypass graft. (Level of Evidence: B)

Class IIa

Patients with ischemia occurring 1 to 3 years postoperatively and preserved left ventricular function with discrete lesions in graft conduits. (Level of Evidence: B)
Disabling angina secondary to new disease in a native coronary circulation. (If angina is not typical, the objective evidence of ischemia should be obtained.) (Level of Evidence: B)
Patients with diseased vein grafts >3 years following coronary artery bypass graft. (Level of Evidence: B)

Class III

Percutaneous coronary intervention to chronic total vein graft occlusions. (Level of Evidence: B)
Patients with multivessel disease, failure of multiple saphenous vein grafts, and impaired left ventricular function. (Level of Evidence: B)

Recommendations for Coronary Intravascular Ultrasound

Class IIa

Assessment of the adequacy of deployment of coronary stents, including the extent of stent apposition and determination of the minimum luminal diameter within the stent. (Level of Evidence: B)
Determination of the mechanism of stent restenosis (inadequate expansion versus neointimal proliferation) and to enable selection of appropriate therapy (plaque ablation versus repeat balloon expansion). (Level of Evidence: B)
Evaluation of coronary obstruction at a location difficult to image by angiography in a patient with a suspected flow-limiting stenosis. (Level of Evidence: C)
Assessment of a suboptimal angiographic result following percutaneous coronary intervention. (Level of Evidence: C)
Diagnosis and management of coronary disease following cardiac transplantation. (Level of Evidence: C)
Establish presence and distribution of coronary calcium in patients for whom adjunctive rotational atherectomy is contemplated. (Level of Evidence: C)
Determination of plaque location and circumferential distribution for guidance of directional coronary atherectomy. (Level of Evidence: B)

Class IIb

Determine extent of atherosclerosis in patients with characteristic anginal symptoms and a positive functional study with no focal stenoses or mild coronary artery disease on angiography. (Level of Evidence: C)
Preinterventional assessment of lesional characteristics and vessel dimensions as a means to select an optimal revascularization device. (Level of Evidence: C)

Class III

When angiographic diagnosis is clear and no interventional treatment is planned. (Level of Evidence: C)

Recommendations for Intracoronary Physiologic Measurements (Doppler Ultrasound, Fractional Flow Reserve [FFR])

Class IIa

Assessment of the physiological effects of intermediate coronary stenoses (30 to 70% luminal narrowing) in patients with anginal symptoms. Coronary pressure or Doppler velocimetry may also be useful as an alternative to performing noninvasive functional testing (e.g., when the functional study is absent or ambiguous) to determine whether an intervention is warranted. (Level of Evidence: B)

Class IIb

Evaluation of the success of percutaneous coronary revascularization in restoring flow reserve and to predict the risk of restenosis. (Level of Evidence: C)
Evaluation of patients with anginal symptoms without an apparent angiographic culprit lesion. (Level of Evidence: C)

Class III

Routine assessment of the severity of angiographic disease in patients with a positive, unequivocal noninvasive functional study. (Level of Evidence: C)

Definitions

Levels of Recommendation: The final recommendations for indications for device therapy are expressed in the standard American College of Cardiology/American Heart Association format as follows:

Class I: Conditions for which there is evidence for and/or general agreement that the procedure or treatment is useful and effective.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.
Class IIb: Usefulness/efficacy is less well established by evidence/opinion.

Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective, and in some cases may be harmful.

Levels of Evidence:

A: Data derived from multiple randomized clinical trials.

B: Data derived from a single randomized trial or nonrandomized studies.

C: Consensus opinion of experts.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

Smith SC, Dove JT, Jacobs AK, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines). J Am Coll Cardiol 2001 Jun;37(8):2239i-2239lxvi . [629 references]

ADAPTATION

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

DATE RELEASED

2001 Jun

GUIDELINE DEVELOPER(S)

American College of Cardiology Foundation - Medical Specialty Society
American Heart Association - Professional Association

SOURCE(S) OF FUNDING

The American College of Cardiology Foundation and the American Heart Association. No outside funding is accepted.

GUIDELINE COMMITTEE

American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty)

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Sidney C. Smith, Jr, MD, FACC, Chair; James T. Dove, MD, FACC; Alice K. Jacobs, MD, FACC; J. Ward Kennedy, MD, MACC; Dean Kereiakes, MD, FACC; Morton J. Kern, MD, FACC; Richard E. Kuntz, MD, FACC; Jeffery J. Popma, MD, FACC; Hartzell V. Schaff, MD, FACC; David O. Williams, MD, FACC

Task Force Members: Raymond J. Gibbons, MD, FACC, Chair; Joseph P. Alpert, MD, FACC; Kim A. Eagle, MD, FACC; David P. Faxon, MD, FACC; Valentin Fuster, MD, PHD, FACC; Timothy J. Gardner, MD, FACC; Gabriel Gregoratos, MD, FACC; Richard O. Russell, MD, FACC; Sidney C. Smith, Jr, MD, FACC

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated yearly and as change occur.

ENDORSER(S)

Society for Cardiovascular Angiography and Interventions

GUIDELINE STATUS

These guidelines will be reviewed 1 year after publication and yearly thereafter and are considered current unless the Task Force updates or withdraws them from distribution.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American College of Cardiology (ACC) Web site:

Print copies: Available from ACC, Resource Center, 9111 Old Georgetown Rd, Bethesda, MD 20814-1699; (800) 253-4636 (US only). Also available from AHA, Public Information, 7272 Greenville Ave, Dallas TX 75231-4596; Reprint No. 71-0206.

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

ACC/AHA guidelines for percutaneous coronary intervention: executive summary and recommendations: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty). (1) J Am Coll Cardiol 2001 Jun 15;37(8):2215-38; (2) Circulation 2001 Jun 19;103(24):3019-41.

Electronic copies: Available from the American College of Cardiology (ACC) Web site.

Also available from the American Heart Association (AHA) Web site.

Print copies: Available from the American College of Cardiology (ACC), Resource Center, 9111 Old Georgetown Rd, Bethesda, MD 20814-1699; (800) 253-4636 (US only). Also available from AHA, Public Information, 7272 Greenville Ave, Dallas TX 75231-4596; Reprint No. 71-0205.

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.

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 (AHA). Download of single copies is permissible from the ACC or AHA Web sites. Reproduction without permission of the ACC/AHA guidelines is prohibited. Permissions requests should be directed to Lisa Bradfield at the ACC, 9111 Old Georgetown Rd, Bethesda, MD 20814-1699; telephone, (301) 493-2362; fax, (301) 897-9745.