Journal of the American College of Cardiology Vol. 37, No. 8, 2001 © 2001 by the American College of Cardiology and the American Heart Association, Inc. ISSN 0735-1097/01/$20.00 Published by Elsevier Science Inc. PII S0735-1097(01)01345-6 ACC/AHA PRACTICE GUIDELINES 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) Endorsed by the Society for Cardiac Angiography and Interventions COMMITTEE MEMBERS SIDNEY C. SMITH, JR, MD, FACC, Chair JAMES T. DOVE, MD, FACC MORTON J. KERN, MD, FACC ALICE K. JACOBS, MD, FACC RICHARD E. KUNTZ, MD, FACC J. WARD KENNEDY, MD, MACC JEFFERY J. POPMA, MD, FACC DEAN KEREIAKES, MD, FACC HARTZELL V. SCHAFF, MD, FACC DAVID O. WILLIAMS, MD, FACC TASK FORCE MEMBERS RAYMONDJ.GIBBONS,MD,FACC,Chair JOSEPH S. ALPERT, MD, FACC TIMOTHYJ.GARDNER,MD,FACC KIMA.EAGLE,MD,FACC GABRIELGREGORATOS,MD,FACC DAVIDP.FAXON,MD,FACC RICHARDO.RUSSELL,MD,FACC VALENTINFUSTER,MD,PHD,FACC SIDNEYC.SMITH,JR,MD,FACC TABLE OF CONTENTS A. Definitions of PCI Success .......................................2239v Preamble...........................................................................................2239ii 1. Angiographic Success............................................2239v I. Introduction........................................................................2239iii 2. Procedural Success.................................................2239v 3. Clinical Success ......................................................2239v II. General Considerations and Background....................2239iii B. Definitions of Procedural Complications...............2239v III. Outcomes.............................................................................2239iv C. Acute Outcome...........................................................2239vi D. Long-Term Outcome and Restenosis..................2239vii This document was approved by the American College of Cardiology Board of E. Predictors of Success/Complications...................2239viii Trustees in April 2001 and by the American Heart Association Science Advisory and 1. Anatomic Factors...............................................2239viii Coordinating Committee in March 2001. 2. Clinical Factors .....................................................2239ix When citing this document, the American College of Cardiology and the American Heart Association would appreciate the following citation format: Smith 3. Risk of Death .........................................................2239x SC, Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma 4. Women ....................................................................2239x JJ, Schaff HV, Williams DO. ACC/AHA guidelines for percutaneous coronary 5. The Elderly Patient ............................................2239xii intervention: a report of the American College of Cardiology/American Heart 6. Diabetes Mellitus ................................................2239xii Association Task Force on Practice Guidelines (Committee to Revise the 1993 Guidelines for Percutaneous Transluminal Coronary Angioplasty). J Am Coll Cardiol 7. Coronary Angioplasty After Coronary Artery 2001;37:2239i–lxvi. Bypass Surgery....................................................2239xiii This document is available on the ACC Web site at www.acc.org and the AHA 8. Specific Technical Considerations .................2239xiii Web site at www.americanheart.org (ask for reprint no. 71-0206). To obtain a reprint 9. Issues of Hemodynamic Support in High-Risk of the shorter version (executive summary and summary of recommendations) to be Angioplasty..........................................................2239xiii published in the June 15, 2001 issue of the Journal of the American College of Cardiology and the June 19, 2001 issue of Circulation for $5 each, call 800-253-4636 (US only) or F. Comparison With Bypass Surgery .......................2239xiv write the American College of Cardiology, Educational Services, 9111 Old Georgetown G. Comparison With Medicine..................................2239xvi Road, Bethesda, MD 20814-1699. To purchase additional reprints up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1,000 or more copies, call 214-706-1466, IV. Institutional and Operator Competency ...................2239xvii fax 214-691-6342, or e-mail: [email protected] (ask for reprint no. 71-0205). A. Quality Assurance ...................................................2239xvii 2239ii Smith et al. JACC Vol. 37, No. 8, 2001 ACC/AHA Percutaneous Coronary Intervention Guidelines June 15, 2001:2239i–lxvi B. Operator and Institutional Volume ....................2239xvii D. Restenosis After Stent Implantation (In-Stent C. On-Site Cardiac Surgical Backup..........................2239xx Restenosis)..............................................................2239xlviii 1. Primary PCI Without On-Site Cardiac 1. Background.......................................................2239xlviii Surgery....................................................................2239xx 2. Radiation for Restenosis..................................2239xlix 2. Elective PCI Without On-Site Surgery .......2239xxi E. Cost-Effectiveness Analysis for PCI...................2239xlix V. Indications........................................................................2239xxii VIII. Future Directions.................................................................2239l A. Asymptomatic or Mild Angina ..........................2239xxiii References ........................................................................................2239li B. Angina Class II to IV or Unstable Angina .....2239xxiv C. Myocardial Infarction...........................................2239xxvii PREAMBLE 1. PCI in Thrombolytic-Ineligible Patients...2239xxvii 2. Post-Thrombolysis PCI................................2239xxviii It is important that the medical profession play a significant 3. Rescue PCI......................................................2239xxviii role in critically evaluating the use of diagnostic procedures 4. PCI for Cardiogenic Shock ...........................2239xxix and therapies in the management and prevention of disease. 5. PCI Hours to Days After Thrombolysis....2239xxix Rigorous and expert analysis of the available data docu- 6. PCI After Thrombolysis in Selected Patient Subgroups ............................................................2239xxx menting relative benefits and risks of those procedures and a. Young and Elderly Post-Infarct therapies can produce helpful guidelines that improve the Patients...........................................................2239xxx effectiveness of care, optimize patient outcomes, and favor- b. Patients With Prior MI .............................2239xxx ably impact the overall cost of care by focusing resources on D. Percutaneous Intervention in Patients With Prior the most effective strategies. Coronary Bypass Surgery.....................................2239xxxii The American College of Cardiology (ACC) and the 1. Early Ischemia After CABG ......................2239xxxiii American Heart Association (AHA) have jointly engaged 2. Late Ischemia After CABG........................2239xxxiii in the preparation of such guidelines in the area of cardio- 3. Early and Late Outcomes of Percutaneous vascular disease since 1980. This effort is directed by the Intervention......................................................2239xxxiv ACC/AHA Task Force on Practice Guidelines, which is 4. Surgery Versus Percutaneous charged with developing and revising practice guidelines for Reintervention .................................................2239xxxiv E. Use of Adjunctive Technology (Intracoronary important cardiovascular diseases and procedures. Experts Ultrasound Imaging, Flow Velocity, and in the subject under consideration are selected from involved Pressure)...................................................................2239xxxv organizations to examine subject-specific data and write 1. Intravascular Ultrasound Imaging (IVUS).2239xxxv guidelines. The process includes additional representatives 2. Coronary Flow Velocity and Coronary from other medical practitioner and specialty groups where Vasodilatory Reserve ......................................2239xxxvi appropriate. Writing groups are specifically charged to 3. Coronary Artery Pressure and Fractional Flow perform a formal literature review, weigh the strength of Reserve .............................................................2239xxxvii evidence for or against a particular treatment or procedure, VI. Management of Patients Undergoing PCI .........2239xxxviii and include estimates of expected-health outcomes in areas A. Experience With New Technologies.............2239xxxviii where data exist. Patient-specific modifiers, comorbidities, 1. Acute Results ................................................2239xxxviii and issues of patient preference that might influence the 2. Late-Term Results.......................................2239xxxviii choice of particular tests or therapies are considered, along B. Antiplatelet and Antithrombotic Therapies and with frequency of follow-up and cost-effectiveness. Coronary Angioplasty (Table 31) ..................2239xxxviii The ACC/AHA Task Force on Practice Guidelines 1. Aspirin, Ticlopidine, Clopidogrel ............2239xxxviii