ACC/AHA PRACTICE GUIDELINES
ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)3,3,3
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
Sidney C. Smith, Jr, MD, FACC, Chair, Committee Member,
James T. Dove, MD, FACC, Committee Member,
Alice K. Jacobs, MD, FACC, Committee Member,
J. Ward Kennedy, MD, MACC, Committee Member,
Dean Kereiakes, MD, FACC, Committee Member,
Morton J. Kern, MD, FACC, Committee Member,
Richard E. Kuntz, MD, FACC, Committee Member,
Jeffery J. Popma, MD, FACC, Committee Member,
Hartzell V. Schaff, MD, FACC, Committee Member,
David O. Williams, MD, FACC, Committee Member,
Raymond J. Gibbons, MD, FACC, Chair, Task Force Member,
Joseph P. Alpert, MD, FACC, Task Force Member,
Kim A. Eagle, MD, FACC, Task Force Member,
David P. Faxon, MD, FACC, Task Force Member,
Valentin Fuster, MD, PhD, FACC, Task Force Member,
Timothy J. Gardner, MD, FACC, Task Force Member,
Gabriel Gregoratos, MD, FACC, Task Force Member,
Richard O. Russell, MD, FACC, Task Force Member and
Sidney C. Smith, Jr, MD, FACC, Task Force Member
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Table of contents
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- I.
- II.
- III.
- Outcomes......2239iv
- Definitions of PCI Success......2239v
- Angiographic Success......2239v
- Procedural Success......2239v
- Clinical Success......2239v
- Definitions of Procedural Complications......2239v
- Acute Outcome......2239vi
- Long-Term Outcome and Restenosis......2239vii
- Predictors of Success/Complications......2239viii
- Anatomic Factors......2239viii
- Clinical Factors......2239ix
- Risk of Death......2239x
- Women......2239x
- The Elderly Patient......2239xii
- Diabetes Mellitus......2239xii
- Coronary Angioplasty After Coronary Artery Bypass Surgery......2239xiii
- Specific Technical Considerations......2239xiii
- Issues of Hemodynamic Support in High-Risk Angioplasty......2239xiii
- Comparison With Bypass Surgery......2239xiv
- Comparison With Medicine......2239xvi
- Institutional and Operator Competency......2239xvii
- Quality Assurance......2239xvii
- Operator and Institutional Volume......2239xvii
- On-Site Cardiac Surgical Backup......2239xx
- Primary PCI Without On-Site Cardiac Surgery......2239xx
- Elective PCI Without On-Site Surgery......2239xxi
- Indications......2239xxii
- Asymptomatic or Mild Angina......2239xxiii
- Angina Class II to IV or Unstable Angina......2239xxiv
- Myocardial Infarction......2239xxvii
- PCI in Thrombolytic-Ineligible Patients......2239xxvii
- Post-Thrombolysis PCI......2239xxviii
- Rescue PCI......2239xxviii
- PCI for Cardiogenic Shock......2239xxix
- PCI Hours to Days After Thrombolysis......2239xxix
- PCI After Thrombolysis in Selected Patient Subgroups......2239xxx
- Young and Elderly Post-Infarct Patients......2239xxx
- Patients With Prior MI......2239xxx
- Percutaneous Intervention in Patients With Prior Coronary Bypass Surgery......2239xxxii
- Early Ischemia After CABG......2239xxxiii
- Late Ischemia After CABG......2239xxxiii
- Early and Late Outcomes of Percutaneous Intervention......2239xxxiv
- Surgery Versus Percutaneous Reintervention......2239xxxiv
- Use of Adjunctive Technology (Intracoronary Ultrasound Imaging, Flow Velocity, and Pressure)......2239xxxv
- Intravascular Ultrasound Imaging (IVUS)......2239xxxv
- Coronary Flow Velocity and Coronary Vasodilatory Reserve......2239xxxvi
- Coronary Artery Pressure and Fractional Flow Reserve......2239xxxvii
- Management of Patients Undergoing PCI......2239xxxviii
- Experience With New Technologies......2239xxxviii
- Acute Results......2239xxxviii
- Late-Term Results......2239xxxviii
- Antiplatelet and Antithrombotic Therapies and Coronary Angioplasty (Table 31)......2239xxxviii
- Aspirin, Ticlopidine, Clopidogrel......2239xxxviii
- Glycoprotein IIb/IIIa Inhibitors......2239xxxix
- Abciximab......2239xxxix
- Eptifibatide......2239xli
- Tirofiban......2239xli
- Heparin......2239xlii
- Heparin Dosing Guidelines......2239xliii
- Post-PCI Management......2239xliii
- Post-Procedure Evaluation of Ischemia......2239xliii
- Risk-Factor Modifications......2239xliv
- Exercise Testing After PCI......2239xliv
- Special Considerations......2239xlv
- Ad-Hoc Angioplasty–PCI at the Time of Initial Cardiac Catheterization......2239xlv
- PCI in Cardiac Transplant Patients......2239xlvii
- Management of Clinical Restenosis......2239xlvii
- Background......2239xlvii
- Clinical and Angiographic Factors......2239xlvii
- Management Strategies......2239xlviii
- Restenosis After Stent Implantation (In-Stent Restenosis)......2239xlviii
- Background......2239xlviii
- Radiation for Restenosis......2239xlix
- Cost-Effectiveness Analysis for PCI......2239xlix
- Future Directions......2239l
- References......2239li
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Preamble
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It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies in the management and prevention of disease. Rigorous and expert analysis of the available data documenting relative benefits and risks of those procedures and therapies can produce helpful guidelines that improve the effectiveness of care, optimize patient outcomes, and favorably impact the overall cost of care by focusing resources on the most effective strategies.
The American College of Cardiology (ACC) and the American Heart Association (AHA) have jointly engaged in the preparation of such guidelines in the area of cardiovascular disease since 1980. This effort is directed by the ACC/AHA Task Force on Practice Guidelines, which is charged with developing and revising practice guidelines for important cardiovascular diseases and procedures. Experts in the subject under consideration are selected from involved organizations to examine subject-specific data and write guidelines. The process includes additional representatives from other medical practitioner and specialty groups where appropriate. Writing groups are specifically charged to perform a formal literature review, weigh the strength of evidence for or against a particular treatment or procedure, and include estimates of expected-health outcomes in areas where data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that might influence the choice of particular tests or therapies are considered, along with frequency of follow-up and cost-effectiveness.
The 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 as changes occur.
These practice guidelines are intended to assist physicians and other healthcare providers in clinical decision making by describing a range of generally acceptable approaches for the diagnosis, management, or prevention of specific diseases or conditions. These 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 physician and patient in light of circumstances specific to that patient.
This committee includes cardiologists with and without involvement in interventional procedures, a cardiac surgeon, and an official representative from the Society for Cardiac Angiography and Interventions (SCA&I). This document was reviewed by three official reviewers nominated by ACC, three official reviewers nominated by AHA, the AHA Committee on Diagnostic and Interventional Cardiac Catheterization, the ACC Interventional Database Committee, the ACC Cath Lab Accreditation Working Group, the ACC Cardiac Catheterization Committee, the SCA&I, and 21 outside reviewers nominated by the Writing Committee. This document was approved for publication by the governing bodies of ACC and AHA and officially endorsed by the SCA&I. These guidelines will be considered current unless the Task Force revises them or withdraws them from distribution.
Raymond J. Gibbons, MD, FACC
Chair, ACC/AHA Task Force on Practice Guidelines
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I. Introduction
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The ACC/AHA Task Force on Practice Guidelines was formed to gather information and make recommendations about appropriate use of technology for the diagnosis and treatment of patients with cardiovascular disease. Percutaneous coronary interventions (PCIs) are an important group of technologies in this regard. Although initially limited to balloon angioplasty and termed percutaneous transluminal coronary angioplasty (PTCA), PCI now includes other new techniques capable of relieving coronary narrowing. Accordingly, in this document, rotational atherectomy, directional atherectomy, extraction atherectomy, laser angioplasty, implantation of intracoronary stents and other catheter devices for treating coronary atherosclerosis are considered components of PCI. In this context PTCA will be used to refer to those studies using primarily balloon angioplasty while PCI will refer to the broader group of percutaneous techniques. These new technologies have impacted the effectiveness and safety profile initially established for balloon angioplasty. Moreover, important advances have occurred in the use of adjunctive medical therapies such as glycoprotein (GP) IIb/IIIa receptor blockers. In addition, since publication of the previous Guidelines in 1993, greater experience in the performance of PCI in patients with acute coronary syndromes and in community hospital settings has been gained. In view of these developments, further review and revision of the guidelines is warranted. This document reflects the opinion of the third ACC/AHA committee charged with revising the guidelines for PTCA to include the broader group of technologies now termed PCI.
Several issues relevant to the Committee’s process and the interpretation of the Guidelines have been noted previously and are worthy of restatement. First, PCI is a technique that has been continually refined and modified; hence continued, periodic Guideline revision is anticipated. Second, these Guidelines are to be viewed as broad recommendations to aid in the appropriate application of PCI. Under unique circumstances, exceptions may exist. These Guidelines are intended to complement, not replace, sound medical judgment and knowledge. They are intended for operators who possess the cognitive and technical skills for performing PCI and assume that facilities and resources required to properly perform PCI are available. As in the past, the indications are categorized as Class I, II, or III, based on a multifactorial assessment of risk as well as expected efficacy viewed in the context of current knowledge and the relative strength of this knowledge. Initially, this document describes the background information that forms the foundation for specific indications. Topics fundamental to coronary intervention are reviewed followed by separate discussions relating to unique technical and operational issues. Formal recommendations for the use of angioplasty are included in Section V. Indications are organized according to clinical presentation. This format is designed to enhance the usefulness of this document for the assessment and care of patients with coronary artery disease (CAD).
This document employs the ACC/AHA style classification as Class I, II, or III. These classes summarize the indications for PCI 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.
The weight of evidence in support of the recommendation for each listed indication is presented as follows:
- Level of Evidence A: Data derived from multiple randomized clinical trials.
- Level of Evidence B: Data derived from a single randomized trial or nonrandomized studies.
- Level of Evidence C: Consensus opinion of experts.
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II. General considerations and background
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Coronary angioplasty was first introduced by Andreas Gruentzig in 1977 (1) as a nonsurgical method for coronary arterial revascularization. Fundamentally, the technique involved advancing a balloon tipped catheter to an area of coronary narrowing, inflating the balloon and then removing the catheter following deflation. Early reports demonstrated that balloon angioplasty could reduce the severity of coronary stenosis and diminish or eliminate objective and subjective manifestations of ischemia (2–4). Although angioplasty was clearly feasible and effective, the scope of coronary disease to be treated was quite narrow. Also, since angioplasty could result in sudden arterial occlusion and subsequent myocardial infarction (MI), immediate access to coronary bypass surgery was essential (5). With experience and time, however, the cognitive and technical aspects as much as the equipment used to perform angioplasty became more refined. Observational reports of large numbers of patients confirmed that coronary angioplasty could be applied to broad groups of coronary patients with higher rates of success and lower rates of complications when compared to initial experiences (6,7). More than 500,000 PCI procedures are performed yearly in the U.S. (8), and it has been estimated that more than 1,000,000 procedures are performed annually worldwide.
The value of coronary angioplasty was further defined by comparing its results to those of alternative methods of treatment. Randomized clinical trials have assessed the outcomes of patients treated by a strategy of initial angioplasty to one of medical therapy alone or to coronary artery bypass surgery (9–14). The results of these trials have clarified the utility of angioplasty in terms of effectiveness, complications, and patient selection. The technique of coronary angioplasty has also been expanded by the development of devices that replace or serve as adjuncts to the balloon catheter. These "new devices" have been thoroughly evaluated and have had a critical impact in enhancing the immediate- and long-term efficacy and safety of coronary angioplasty. The following section of this report expands on this background and describes the practice of PCI as it is applied today.
New coronary devices have expanded the clinical and anatomical indications for revascularization initially limited by balloon catheter angioplasty. For example, stents reduce both the acute risk of major complications and late-term restenosis. The success of new coronary devices in meeting these goals is in part represented by the less frequent use of balloon angioplasty alone (<30%) and the high (>70%) penetration of coronary stenting in the current practice of interventional cardiology (Fig. 1). Atherectomy devices and stenting, associated with improved acute angiographic and clinical outcomes compared to balloon angioplasty, in specific subsets, continue to be applied to a wider patient domain that includes multivessel disease and complex coronary anatomy. However, strong evidence (level A data from multiple randomized clinical trials) is only available for stenting in selected patients undergoing single-vessel PCI.
The range of new, non-balloon revascularization technology approved by the Food and Drug Administration (FDA) for use in native or graft coronary arteries includes balloon expandable stents, atherectomy by the Transluminal Extraction Catheter (TEC), Directional Coronary Atherectomy (DCA), rotational atherectomy, angiojet thrombolysis catheter, and Excimer Laser Coronary Atherectomy (ELCA). A variety of devices is under investigation including new designs of balloon or self-expanding stents, mechanical thrombectomy devices, and local radiation devices intended to reduce restenosis. These guidelines will focus on the FDA-approved balloon related and non-balloon coronary revascularization devices.
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III. Outcomes
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The outcomes of coronary interventional procedures are measured in terms of success and complications and are related to the mechanisms of the employed devices, as well as the clinical and anatomic patient-related factors. Complications can be divided into two categories: 1) those common to all arterial catheterization procedures and 2) those related to the specific technology used for the coronary procedure. Specific definitions of success and complications exist, and where appropriate, the definitions used herein are consistent with the ACC-National Cardiovascular Data RegistryTM Catheterization Laboratory Module Version 2.0 (15). With increased operator experience, new technology, and adjunctive pharmacotherapy, the overall success and complication rates of angioplasty have improved.
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A. Definitions of PCI success
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The success of a PCI procedure may be defined by angiographic, procedural, and clinical criteria.
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1. Angiographic success
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A successful PCI produces substantial enlargement of the lumen at the target site. The consensus definition prior to the widespread use of stents was the achievement of a minimum stenosis diameter reduction to <50% in the presence of grade 3 TIMI flow (assessed by angiography) (16). However, with the advent of advanced adjunct technology, including coronary stents, a minimum stenosis diameter reduction to <20% has been the clinical benchmark of an optimal angiographic result. Frequently, there is a disparity between the visual assessment and computer-aided quantitative stenosis measurement (17,18), and the determination of success may be problematic when success rates are self-reported.
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2. Procedural success
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A successful PCI should achieve angiographic success without in-hospital major clinical complications (e.g., death, MI, emergency coronary artery bypass surgery) during hospitalization (2,16). Although the occurrence of emergency coronary artery bypass surgery and death are easily identified end points, the definition of procedure-related MI has been debated. The development of Q-waves in addition to a threshold value of CK elevation has been commonly used. However, the significance of enzyme elevations in the absence of Q-waves remains a subject of investigation and debate. Several reports have identified non–Q-wave MIs with CK-MB elevations 3 to 5 times the upper limit of normal as having clinical significance (19,20). Thus a significant increase in CK-MB without Q-waves is considered by most to qualify as an associated complication of PCI.
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3. Clinical success
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Table of contents
Preamble
