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• W2040393337 abstract "HomeCirculationVol. 103, No. 24ACC/AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines)—Executive Summary Free AccessOtherPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessOtherPDF/EPUBACC/AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines)—Executive Summary 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. SmithJr, James T. Dove, Alice K. Jacobs, J. Ward Kennedy, Dean Kereiakes, Morton J. Kern, Richard E. Kuntz, Jeffery J. Popma, Hartzell V. Schaff and David O. Williams Raymond J. Gibbons, Joseph P. Alpert, Kim A. Eagle, David P. Faxon, Valentin Fuster, Timothy J. Gardner, Gabriel Gregoratos, Richard O. Russell and Sidney C. SmithJr Sidney C. SmithJrSidney C. SmithJr Committee Members Search for more papers by this author , James T. DoveJames T. Dove Committee Members Search for more papers by this author , Alice K. JacobsAlice K. Jacobs Committee Members Search for more papers by this author , J. Ward KennedyJ. Ward Kennedy Committee Members Search for more papers by this author , Dean KereiakesDean Kereiakes Committee Members Search for more papers by this author , Morton J. KernMorton J. Kern Committee Members Search for more papers by this author , Richard E. KuntzRichard E. Kuntz Committee Members Search for more papers by this author , Jeffery J. PopmaJeffery J. Popma Committee Members Search for more papers by this author , Hartzell V. SchaffHartzell V. Schaff Committee Members Search for more papers by this author and David O. WilliamsDavid O. Williams Committee Members Search for more papers by this author Raymond J. GibbonsRaymond J. Gibbons Task Force Members Search for more papers by this author , Joseph P. AlpertJoseph P. Alpert Task Force Members Search for more papers by this author , Kim A. EagleKim A. Eagle Task Force Members Search for more papers by this author , David P. FaxonDavid P. Faxon Task Force Members Search for more papers by this author , Valentin FusterValentin Fuster Task Force Members Search for more papers by this author , Timothy J. GardnerTimothy J. Gardner Task Force Members Search for more papers by this author , Gabriel GregoratosGabriel Gregoratos Task Force Members Search for more papers by this author , Richard O. RussellRichard O. Russell Task Force Members Search for more papers by this author and Sidney C. SmithJrSidney C. SmithJr Task Force Members Search for more papers by this author Originally published19 Jun 2001https://doi.org/10.1161/01.CIR.103.24.3019Circulation. 2001;103:3019–3041I. IntroductionThe American College of Cardiology/American Heart Association (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 (PCI) are an important group of technologies in this regard. Although initially limited to PTCA, 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 PTCA while PCI will refer to the broader group of percutaneous techniques. These new technologies have impacted the effectiveness and safety profile initially established for PTCA. 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 ran domized clinical trials.Level of Evidence B: Data derived from a single ran domized trial or nonrandomized studies.Level of Evidence C: Consensus opinion of experts.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.II. General Considerations and BackgroundMore than 500,000 PCI procedures are performed yearly in the U.S., and it has been estimated that more than 1,000,000 procedures are performed annually worldwide. 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 PTCA alone (<30%) and the high (>70%) penetration of coronary stenting in the current practice of interventional cardiology. Atherectomy devices and stenting, associated with improved acute angiographic and clinical outcomes compared to PTCA, 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. These Guidelines will focus on the Food and Drug Administration (FDA) approved balloon-related and nonballoon coronary revascularization devices.III. OutcomesThe 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. With increased operator experience, new technology, and adjunctive pharmacotherapy, the overall success and complication rates of angioplasty have improved.A. Definitions of PCI SuccessThe success of a PCI procedure may be defined by angiographic, procedural, and clinical criteria.1. Angiographic SuccessA 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). 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.2. Procedural SuccessA successful PCI should achieve angiographic success without in-hospital major clinical complications (e.g., death, myocardial infarction [MI], emergency coronary artery bypass surgery [CABG]) during hospitalization. Although the occurrence of emergency artery coronary 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. Thus a significant increase in CK-MB without Q-waves is considered by most to qualify as an associated complication of PCI.If serial determinations are performed after PCI, an abnormally high value (CK-MB >1 times normal) can be expected in 10 to 15% of PTCA procedures, 15 to 20% of stent procedures, 25 to 35% of atherectomy procedures, and >25% for any device used in saphenous vein grafts (SVGs) or long lesions with a high atherosclerotic burden, even in the absence of other signs and symptoms of MI. There is no accepted consensus on what level of CK-MB index (with or without clinical or electrocardiographic [ECG] findings) is indicative of a clinically important MI following the interventional procedure. Cardiac troponin T and I have now been introduced as measurements of myocardial necrosis and have been proven to be more sensitive and specific than CK-MB. However, prognostic criteria after PCI based on troponin T and I have not yet been developed. The Writing Committee recommends that CK-MB determination be performed on all patients who have signs or symptoms suggestive of MI following the procedure or in patients in whom there is angiographic evidence of abrupt vessel closure, important side branch occlusion, or new and persistent slow coronary flow. In patients in whom a clinically driven CK-MB determination is made, a CK-MB of >3 times the upper limit of normal would constitute a clinically significant MI.3. Clinical SuccessIn the short term, a clinically successful PCI includes anatomic and procedural success with relief of signs and/or symptoms of myocardial ischemia after the patient recovers from the procedure. The long-term clinical success requires that the short-term clinical success remains durable and that the patient has persistent relief of signs and symptoms of myocardial ischemia for more than 6 months after the procedure. Restenosis is the principal cause of lack of long-term clinical success when a short-term clinical success has been achieved.B. Definitions of Procedural ComplicationsAs outlined in the 1998 coronary interventional document, procedural complications are divided into six basic categories: death, MI, emergency CABG, stroke, vascular access site complications, and contrast agent nephropathy. Key data elements and definitions to measure the clinical management and outcomes of patients undergoing diagnostic catheterization and/or PCI have been defined in the Clinical Data Standards document and the ACC-National Cardiovascular Data Registry™ Catheterization Laboratory Module version 2.0. These rigorous definitions for key adverse events are endorsed by this Writing Committee for inclusion in the present PCI Guidelines (Table 1).C. Acute OutcomeImprovements in balloon technology coupled with the increased use of nonballoon devices, particularly stents (which are effective in treating abrupt vessel closure) and GP IIb/IIIa platelet receptor antagonists have favorably influenced acute procedural outcome. This combined balloon/device/pharmacologic approach to coronary intervention in elective procedures has resulted in angiographic success rates of 96 to 99%, with Q-wave MI rates of 1 to 3%, emergency coronary bypass surgery rates of 0.2 to 3%, and unadjusted in-hospital mortality rates of 0.5 to 1.4%.D. Long-Term Outcome and RestenosisAlthough improvements in technology, including stents and new pharmacologic therapy, have resulted in an improved acute outcome of the procedure, the impact of these changes on long-term (5 to 10 years) outcome may be less dramatic where factors such as advanced age, reduced left ventricular (LV) function, and complex multivessel disease in patients currently undergoing PCI may have a more important influence. In addition, available data on long-term outcome are mostly limited to patients undergoing PTCA. Ten-year follow-up of the initial cohort of patients treated with PTCA revealed an 89.5% survival rate (95% in patients with single-vessel disease, 81% in patients with multivessel disease). In patients within the 1985–1986 NHLBI PTCA Registry, 5-year survival was 92.9% for patients with single-vessel disease, 88.5% for those with 2-vessel disease, and 86.5% for those with 3-vessel disease. In patients with multivessel disease undergoing PTCA in BARI, 5-year survival was 86.3% and infarct-free survival was 78.7%. Specifically, 5-year survival was 84.7% in patients with 3-vessel disease and 87.6% in patients with 2-vessel disease.In addition to the presence of multivessel disease, other clinical factors adversely impact late mortality. In randomized patients with treated diabetes in BARI, the 5-year survival was 65.5%, and the cardiac mortality was 20.6% in comparison to 5.8% cardiac mortality in patients without treated diabetes, although among eligible but not randomized diabetic patients, the 5-year cardiac mortality was 7.5%. In the 1985–1986 NHLBI PTCA Registry, 4-year survival was significantly lower in women (89.2%) in comparison to men (93.4%). In addition, although LV dysfunction was not associated with an increase in in-hospital mortality or nonfatal MI in patients undergoing PTCA in the same registry, it was an independent predictor of a higher long-term mortality.A major determinant of event-free survival following coronary intervention is the incidence of restenosis which had, until the development of stents, remained fairly constant, despite multiple pharmacologic and mechanical approaches to limit this process (Table 2). Depending on the definition, (i.e., whether clinical or angiographic restenosis or target lesion revascularization is measured), the incidence of restenosis following coronary intervention had been 30 to 40%, and higher in certain clinical and angiographic subsets.Although multiple clinical factors (diabetes, unstable angina, acute MI, prior restenosis), angiographic factors (proximal left anterior descending artery, small vessel diameters, total occlusion, long lesion length, SVG), and procedural factors (higher post-procedure percent diameter stenosis, smaller minimal lumen diameter, and smaller acute gain), have been associated with an increased incidence of restenosis, the ability to integrate these factors and predict the risk of restenosis in individual patients following the procedure remains difficult. The most promising potential approaches to favorably impact the restenosis process relate to: 1) the ability to decrease elastic recoil and remodeling using intracoronary stents, and 2) to the ability to reduce intimal hyperplasia using catheter-based ionizing radiation. More than 6,300 patients have been studied in 12 randomized clinical trials to assess the efficacy of PTCA vs. stents to reduce restenosis (Table 3).In addition, randomized studies in patients with in-stent restenosis have shown that both intracoronary gamma and beta radiation significantly reduced the rate of subsequent angiographic and clinical restenosis by 30 to 50%.E. Predictors of Success/Complications1. Anatomic FactorsThe risk of PTCA in the pre-stent era relative to anatomic subsets has been identified in previous NHLBI PTCA Registry data and by the ACC/AHA Task Force. The lesion classification based on severity of characteristics proposed in the past has been principally altered using the present PCI techniques, which capitalize on the ability of stents to manage initial and subsequent complications of coronary interventions. As a result the Committee has revised the previous ACC/AHA lesion classification system to reflect low, moderate, and high risk (Table 4) in accordance with the PCI Clinical Data Standards from the ACC-National Cardiovascular Data Registry™.2. Clinical FactorsCoexistent clinical conditions can increase the complication rates for any given anatomic risk factor. The clinical risk factors associated with in-hospital adverse events have been further evaluated with additional experience during the PCI era and summarized based on odds ratio >2.0 or results of multivariate analysis (Table 5).3. Risk of DeathIn the majority of patients undergoing elective PCI, death as a result of PCI is directly related to the occurrence of coronary artery occlusion and is most frequently associated with pro-nounced LV failure. The clinical and angiographic variables associated with increased mortality include advanced age, female gender, diabetes, prior MI, multivessel disease, left main or equivalent coronary disease, a large area of myocardium at risk, pre-existing impairment of LV or renal function, and collateral vessels supplying significant areas of myocardium that originate distal to the segment to be dilated (Table 5).4. WomenIn comparison to men, women undergoing PCI are older and have a higher incidence of hypertension, diabetes mellitus, hypercholesterolemia, and comorbid disease. Early reports of patients undergoing PTCA revealed a lower procedural success rate in women; however, more recent studies have noted similar angiographic outcome and incidence of MI and emergency coronary bypass surgery in women and men. Although reports have been inconsistent, in several large-scale registries, in-hospital mortality is significantly higher in women and an independent effect of gender on acute mortality following PCI persists after adjustments for the baseline higher-risk profile in women.5. The Elderly PatientAge >75 years is one of the major clinical variables associated with increased risk of complications. In the elderly population, the morphologic and clinical variables are compounded by advanced years with the very elderly having the highest-risk of adverse outcomes. In the stent era, procedural success rates and short-term outcomes are comparable to those for nonoctogenarians. Thus, with rare exception (primary PCI for cardiogenic shock for patients >75 years), a separate category has not been created in these Guidelines for the elderly. However, their higher incidence of comorbidities should be taken into account when considering the need for PCI.6. Diabetes MellitusIn the TIMI-IIB study of MI, patients with diabetes mellitus had significantly higher 6-week (11.6% vs. 4.7%), 1-year (18.0% vs. 6.7%), and 3-year (21.6% vs. 9.6%) mortality rates compared to nondiabetic patients. The BARI trial, in which stents and abciximab were not used, showed that survival was better for patients with treated diabetes undergoing CABG with an arterial conduit than for those undergoing angioplasty. Stenting decreases the need for target revascularization procedures in diabetic patients compared with PTCA. The efficacy of stenting with GP IIb/IIIa inhibitors was assessed in the diabetic population compared to those without diabetes in a substudy of the EPISTENT trial. Irrespective of revascularization strategy abciximab significantly reduced 6-month death and MI rates in patients with diabetes for all strategies. Likewise, 6-month target-vessel revascularization was reduced in the stent/abciximab group approach.7. Coronary Angioplasty After Coronary Artery Bypass SurgeryAlthough speculated to be at higher risk, patients having PCI of native vessels after prior coronary bypass surgery have, in recent years, nearly equivalent interventional outcomes and complication rates compared to patients having similar interventions without prior surgery. For PCI of SVG, studies indicate that the rate of successful angioplasty exceeds 90%, death <1.2%, Q-wave MI <2.5%. The incidence of non–Q-wave MI may be higher than that associated with native coronary arteries.Use of GP IIb/IIIa blockers has not been shown to improve results of angioplasty in vein grafts. The native vessels should be treated with PCI if feasible. Patients with older and/or severely diseased SVGs may benefit from elective repeat coronary artery bypass graft surgery rather than PCI.8. Specific Technical ConsiderationsCertain outcomes of PCI may be specifically related to the technology utilized for coronary recanalization. Antecedent unstable angina appears to be a clinical predictor of slow flow and periprocedural infarction following ablative technologies and direct platelet activation has been demonstrated to occur with both directional and rotational atherectomy.Coronary perforation may occur more commonly following the use of ablative technologies including rotational, directional or extraction atherectomy, and excimer laser coronary angioplasty. Coronary perforation complicates PCI more frequently in the elderly and in women. While 20% of perforations may be secondary to the coronary guidewire, most are related to the specific technology used.9. Issues of Hemodynamic Support in High-Risk AngioplastyElective high-risk PCI can be performed safely without intra-aortic balloon pump (IABP) or cardiopulmonary support (CPS) in most circumstances. Emergency high-risk PCI such as direct PCI for acute MI can usually be performed without IABP or CPS. CPS for high-risk PCI should be reserved only for patients at the extreme end of the spectrum of hemodynamic compromise, such as those patients with extremely depressed LV function and patients in cardiogenic shock. However, it should be noted that in patients with borderline hemodynamics, ongoing ischemia, or cardiogenic shock, insertion of an intra-aortic balloon just prior to coronary instrumentation has been associated with improved outcomes. Furthermore, it is reasonable to obtain vascular access in the contralateral femoral artery prior to the procedure in patients in whom the risk of hemodynamic compromise is high, thereby facilitating intra-aortic balloon insertion, if necessary.In patients having a higher-risk profile, consideration of alternative therapies, particularly CABG, formalized surgical standby, or periprocedural hemodynamic support should be addressed before proceeding with PCI.F. Comparison With Bypass SurgeryThe major advantage of PCI is its relative ease of use, avoiding general anesthesia, thoracotomy, extracorporeal circulation, CNS complications, and prolonged convalescence. Repeat PCI can be performed more easily than repeat bypass surgery, and revascularization can be achieved more quickly in emergency situations. The disadvantages of PCI are early restenosis and the inability to relieve many totally occluded arteries and/or those vessels with extensive atherosclerotic disease.Coronary artery bypass surgery has the advantages of greater durability (graft patency rates exceeding 90% at 10 years with arterial conduits) and more complete revascularization irrespective of the morphology of the obstructing atherosclerotic lesion. Generally speaking, the greater the extent of coronary atherosclerosis and its diffuseness, the more compelling the choice of CABG, particularly if LV function is depressed. Patients with lesser extent of disease and localized lesions are good candidates for endovascular approaches.Percutaneous transluminal coronary angioplasty and CABG have been compared in many nonrandomized and randomized studies. The most accurate comparisons of outcomes are best made from prospective randomized trials of patients suitable for either treatment. Although results of these trials provide useful information for selection of therapy in several patient subgroups, prior studies of PTCA may not reflect outcome of current PCI practice, which includes frequent use of stents and antiplatelet drugs. Similarly, many previous studies of CABG may not reflect outcome of current surgical practice in which arterial conduits are used whenever practicable. Beating heart bypass operations are also employed for selected patients with single-vessel disease with reduced morbidity. In addition, patients are selected for PCI (with or without stenting) because of certain lesion characteristics, and these anatomical criteria are not required for CABG.Despite these limitations, some generalizations can be made from comparative trials of PTCA and CABG. First, for most patients with single-vessel disease, late survival is similar with either revascularization strategy, and this might be expected given the generally good prognosis of most patients with single-vessel disease managed medically.In the ARTS trial, the first trial to compare stenting with surgery, there was no significant difference in mortality between PCI and surgical groups at one year. The main difference compared to previous PTCA and CABG trials was an approximate 50% reduction in the need for repeat revascularization in a group randomized to PCI with stent placement.Direct comparison of initial strategies of PCI or CABG in patients with multivessel coronary disease is possible only by randomized trials because of selection criteria of patients for PCI. There have been five large (>300 patients) randomized trials of PTCA versus CABG and two smaller studies. These trials demonstrate that in appropriately selected patients with multivessel coronary disease, an initial strategy of standard PTCA yields similar overall outcomes (e.g., death, MI) compared to initial revascularization with coronary artery bypass.An important exception to the conclusion of the relative safety of PCI in multivessel disease is the subgroup of patients with treated diabetes mellitus. Among treated diabetic patients in BARI assigned to PTCA, 5-year survival was 65.5% compared to 80.6% for patients having CABG (p = 0.003); the improved outcome with CABG was due to reduced cardiac mortality (5.8% vs. 20.6%, p = 0.0003), which was confined to those receiving at least one internal mammary artery graft.G. Comparison With MedicineThere has been a considerable effort made to evaluate the relative effectiveness of bypass surgery as compared to PCI for coronary artery revascularization. In contrast to this, very little effort has been directed toward comparing medical therapy with PCI for the management of stable and unstable angina.Based on the limited data available from randomized trials (Table 6) comparing medical therapy with PTCA, it seems prudent to consider medical therapy for the initial management of most patients with Canadian Cardiovascular Society Classification Class I and II and reserve PTCA and CABG for those patients with more severe symptoms and ischemia. The symptomatic individual patient who wishes to remain physically active, regardless of age, will more often require PCI. The results of the ACIP trial indicate that higher-risk patients with asymptomatic ischemia and significant CAD who undergo complete revascularization with CABG or PTCA may have a better outcome as compared to those with medical management.IV. Institutional and Operator CompetencyA. Quality AssuranceA mechanism for valid peer review must be established and ongoing at each institution performing PCI. Interventional cardiology procedures are associated with complications that in general are inversely related to operator and institutional volume. The mechanism for institutional review should provide an opportunity for interventionalists as well as physicians who do not perform angioplasty, but are knowledgeable about it, to review overall results of" @default.
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• W2040393337 date "2001-06-19" @default.
• W2040393337 modified "2023-10-10" @default.
• W2040393337 title "ACC/AHA Guidelines for Percutaneous Coronary Intervention (Revision of the 1993 PTCA Guidelines)—Executive Summary" @default.
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