2012 SCAI+特设性PCI介入治疗共识声明

Clinical Decision Making Ad Hoc Percutaneous Coronary Intervention: A Consensus Statement From the Society for Cardiovascular Angiography and Interventions James C. Blankenship,1* MD, Osvaldo S. Gigliotti,2 MD, Dmitriy N. Feldman,3 MD, Timothy A. Mixon,4 MD, Rajan A.G. Patel,5 MD, Paul Sorajja,6 MD, Steven J. Yakubov,7 MD, and Charles E. Chambers,8 MD Percutaneous coronary interventions (PCI) may be performed during the same session as diagnostic catheterization (ad hoc PCI) or at a later session (delayed PCI). Randomized trials comparing these strategies have not been performed; cohort studies have not identified con- sistent differences in safety or efficacy between the two strategies. Ad hoc PCI has increased in prevalence over the past decade and is the default strategy for treating acute coronary syndromes. However, questions about its appropriateness for some patients with stable symptoms have been raised by the results of recent large trials comparing PCI to medical therapy or bypass surgery. Ad hoc PCI for stable ischemic heart disease requires preproce- dural planning, and reassessment after diagnostic angiography must be performed to ensure its appropriateness. Patients may prefer ad hoc PCI because it is convenient. Payers may prefer ad hoc PCI because it is cost-efficient. The majority of data confirm equivalent out- comes in ad hoc versus delayed PCI. However, there are some situations in which delayed PCI may be safer or yield better outcomes. This document reviews patient subsets and clini- cal situations in which one strategy is preferable over the other. VC 2012Wiley Periodicals, Inc. Key words: stenting; percutaneous coronary intervention; angina INTRODUCTION Percutaneous coronary intervention (PCI) has evolved since its inception 35 years ago. Initially, PCI required cardiac surgery and anesthesiology standby, and emer- gency coronary artery bypass surgery (CABG) was per- formed in �5% of PCI patients. As PCI became safer and more predictable, it was more often performed dur- ing the same session as diagnostic catheterization (termed ‘‘ad hoc’’ PCI). More recently, it has been sug- gested that ad hoc PCI may be performed too frequently in situations in which it would be preferable to pause for additional informed consent or consideration of alterna- tives.1 Guidelines and appropriate use criteria for PCI are frequently being revised, adding to the factors an interventional cardiologist must consider before per- forming ad hoc PCI.2,3 Recommendations for the appro- priate performance of ad hoc PCI were published 8 years ago by the Society for Cardiovascular Angiography and Interventions (SCAI).4 The purpose of this paper is to update those recommendations in light of recent trial results and practice trends. 1Department of Cardiology, Geisinger Medical Center, Dan- ville, Pennsylvania 2Seton Heart Institute, Austin, Texas 3Division of Cardiology, Weill Cornell Medical College, New York, New York 4Department of Cardiology, Texas A&M College of Medicine, Temple, Texas 5Department of Cardiology, Ochsner Clinic Foundation, New Orleans, Los Angeles 6Department of Cardiology, Mayo Clinic, Rochester, Minnesota 7Ohio Health Research Institute, Riverside Methodist Hospital, Columbus, Ohio 8Department of Cardiology, Hershey Medical Center, Hershey, Pennsylvania Conflict of interest: There are no conflicts of interest relevant to this article. *Correspondence to: James C. Blankenship, MD, FSCAI, Department of Cardiology, 27-75 Geisinger Medical Center, Danville, PA 17822. E-mail: jblankenship@geisinger.edu Received 17 September 2012; Revision accepted 7 October 2012 DOI 10.1002/ccd.24701 Published online 00 Month 2012 in Wiley Online Library (wiley onlinelibrary.com) J_ID: Z7V Customer A_ID: 12-1256 Cadmus Art: CCD24701 Date: 19-November-12 Stage: Page: 1 ID: guganp I Black Lining: [ON] I Time: 15:05 I Path: N:/3b2/CCD#/Vol00000/120481/APPFile/JW-CCD#120481 VC 2012 Wiley Periodicals, Inc. Catheterization and Cardiovascular Interventions 00:000–000 (2012) 医 脉 通 ww w. me dl iv e. cn DEFINITIONS OF AD HOC AND DELAYED PCI Coronary angiography followed by PCI is performed in various scenarios, including the following. Angiography and PCI in the Same Session (Ad Hoc PCI) Diagnostic catheterization is followed in the same session, or same sitting, by PCI. Angiography and PCI on Separate Days (Delayed PCI) After diagnostic catheterization, the patient is taken off the catheterization laboratory table; PCI is per- formed on a separate day. Angiography and PCI on the Same Day but Separate Sessions (same-Day PCI) After diagnostic catheterization, the patient is taken off the catheterization laboratory table and returned later in the same day for PCI. This strategy combines some of the efficiencies of ad hoc PCI while allowing for a ‘‘pause’’ for additional evaluation or treatment, discussion with the patient after sedation has resolved, or expert consultation. Databases usually do not dis- tinguish between ad hoc and same-day PCI, and there are no reliable data on its prevalence or clinical impact. EVOLUTION OF AD HOC PCI All trials of ad hoc PCI discussed below used regis- try data; randomized trials of ad hoc PCI have not been conducted. Ad Hoc PCI in the Prestent Era Ten studies5–14 have reported the results of ad hoc PTCA. Of these, seven compared ad hoc with delayed PTCA, and all found similar overall angiographic suc- cess and acute complication rates for ad hoc and delayed PTCA (Table T1I). Kimmel et al.12 reported that ad hoc angioplasty was associated with an increased risk of acute complications in patients with unstable angina, multivessel coronary artery disease (CAD), advanced age, and multilesion angioplasty. Overall, these studies provided evidence that ad hoc angio- plasty, compared to delayed angioplasty, was safe in selected patients. Ad Hoc PCI in the Stent Era Shubrooks et al.15 reported the outcome of 4,136 PCIs performed in seven New England centers in 1997. Ad hoc PCI was performed in 42% of PCIs with similar clinical success and ischemic complication rates compared to delayed PCI. Vascular complication rates were lower in patients undergoing ad hoc PCI (0.6% vs. 1.6%, P ¼ 0.006). Goldstein et al.16 reported outcomes of 62,873 PCIs performed in 33 centers from 1995 to 1998, using data TABLE I. Studies of Ad Hoc Versus Delayed Percutaneous Coronary Intervention Angiographic success Inpatient death Procedural myocardial infarction Emergent coronary bypass surgery Author (years enrolled) No. patients (Ad hoc/delayed) Ad hoc (%) Delayed (%) Ad hoc (%) Delayed (%) Ad hoc (%) Delayed (%) Ad hoc (%) Delayed (%) Angioplasty era O’Keefe et al.8 (1985–1986) 120/404 89 91 0 1.2 0.8 1.4 1.6 3.4 O’Keefe et al.9 (1984–1988) 73/5,351 95 95 0.5 0 0.9 0.5 2.3 0.5 Lund et al.10 (1991–1992) 124/? 92.1 88.4 NA NA NA NA NA NA Rozenman et al.11 (1989–1992) 1,719/2,069 93.9 92.9 0.8 1.3 1.0 1.3 0.5 0.3 Kimmel et al.12 (1992–1995)a 6,152/29,548 NA NA 0.29 0.16 0.73 0.15 1.3 1.09 Le Feuvre et al.13 (1990–2000) 1,809/631 92c 88c 0.9 0.4 2.2 2.3 0.6 0.9 Panchamukhi and Flaker14 (1995–1996) 244/113 92 91 0 0 NA NA 0.8 0 Stent era (>50% of PCI utilized stents) Shubrooks et al.15 (1997)a 1,748/2,388 93.7b 93.6b 0.6 0.5 2.0 2.6 0.9 0.8 Goldstein et al.16 (1995–1998)a 38,411/23,462 NA NA 0.46 0.56 NA NA NA NA Krone et al.18 (2001–2003)a 41,524/27,004 91.7c 92.5c 0.13 0.16 NA NA 0.59c 0.34c Feldman et al.17 (2001–2002)a 28,904/18,116 NA NA 0.4 0.4 NA NA 0.2 0.3 Hannan et al.19 (2003–2005)a 38,431/8,134 NA NA 0.25c 0.45c 0.85 0.95 NA NA Good et al.20 (2004)a 557/23 97.7 100 0.7 0 3.8c 8.7c 0.4 0 aStatistical analyses involved multivariate analysis. bClinical success is reported since angiographic success was not available. cP < 0.05. NA ¼ not available J_ID: Z7V Customer A_ID: 12-1256 Cadmus Art: CCD24701 Date: 19-November-12 Stage: Page: 2 ID: guganp I Black Lining: [ON] I Time: 15:05 I Path: N:/3b2/CCD#/Vol00000/120481/APPFile/JW-CCD#120481 2 Blankenship et al. Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI). 医 脉 通 ww w. me dl iv e. cn from the New York State Department of Health PCI database. Ad hoc PCI was performed in 62% of PCIs with similar mortality as delayed PCI overall but with increased risk of mortality in ‘‘high-risk’’ subgroups [i.e., those with congestive heart failure (odds ratio ¼ 1.6; P ¼ 0.04) or class IV angina (odds ratio ¼ 1.6; P ¼ 0.04)]. Feldman et al.17 reported the outcome of 47,020 patients undergoing PCI from 2000 to 2001 using data from the same New York State PCI Registry analyzed by Goldstein et al. years earlier.16 Ad hoc PCI was performed in 61%. Mortality, major adverse cardiac events (death, emergency CABG, or stroke), and inci- dence of renal failure/dialysis during hospitalization were similar for ad hoc and delayed PCI. Patients with high-risk features (age >80 years, class IV angina, congestive heart failure on admission, renal failure, and multivessel CAD) had similar in-hospital clinical outcomes after either treatment approach. Krone et al.18 reported the outcomes of 68,528 PCIs with stable angina from 2001 to 2003 using data from the American College of Cardiology National Cardio- vascular Data Registry. Ad hoc PCI was performed in 61%. While ad hoc PCI was associated with lower suc- cess rates, and slightly more frequent unplanned CABG and emergency repeat PCIs, the differences between ad hoc and delayed PCI became nonsignificant in a multivariate analysis. Procedural mortality, cere- brovascular events, and renal failure were similar between groups. Hannan et al.19 reported outcomes of 46,565 PCIs between 2003 and 2005 using data from the New York PCI Reporting System. Ad hoc PCI was performed in 83% of PCIs. Adjusted in-hospital mortality rates were similar for ad hoc and delayed PCI. Ad hoc PCI was associated with lower rates of renal failure (0.07% vs. 0.14%) and myocardial infarction (MI) (0.85% vs. 0.95%) compared with delayed PCI, although P values were not reported. After 36 months of follow-up, ad hoc PCI was associated with lower mortality (risk- adjusted hazard ratio 0.76, P < 0.0001). The mortality reduction associated with ad hoc PCI was present in ‘‘high-risk’’ groups (women, age � 75 years, multives- sel disease, congestive heart failure, and class IV an- gina). The data did not explain why delayed PCI was associated with higher mortality overall and in high- risk subgroups; the authors suggested it could be due to increased morbidity associated with a second PCI procedure or unidentified biases in their data. Good et al.20 reported the outcomes of 580 PCIs in 2004 from a single center. Ad hoc PCI was performed in 96% of PCIs. Delayed PCI patients were older with a higher frequency of prior MI, congestive heart fail- ure, chronic kidney disease, left ventricular systolic dysfunction, and prior CABG. Outcomes were similar for both groups except for a higher incidence of peri- procedural MI in the delayed PCI group (8.7% vs. 3.8%, P ¼ 0.023). Ad Hoc PCI in the Current Era The prevalence of ad hoc PCI has increased over the past decade.15–20 This increase is in part due to the proven efficacy of PCI (usually performed ad hoc) for acute coronary syndromes (ACS)21 and to studies suggesting that ad hoc PCI is safe and effective compared to delayed PCI.15,17,19,20 The appropriateness of ad hoc PCI has been chal- lenged recently, particularly for patients at either end of the spectrum of CAD—those with mild CAD in whom medical therapy might be sufficient and those with extensive and complex CAD for whom the rela- tive benefit of PCI versus CABG has been ques- tioned.22,23 For example, it has been suggested that, for patients with stable ischemic heart disease (SIHD), delay or deferral to discuss treatment options and to in- tensify medical therapy may be appropriate.22,24,25 For patients with extensive (i.e., complex multivessel, or unprotected left main) CAD, it has been suggested that a ‘‘heart team’’ approach allowing input from both an interventional cardiologist and a cardiac surgeon may be preferable.2,23 GUIDELINES AND APPROPRIATE USE CRITERIA RELEVANT TO AD HOC PCI PCI Guidelines The first PCI guidelines,26 published in 1988, rec- ommended against ad hoc balloon angioplasty. Subse- quent PCI guidelines characterized ad hoc PCI as ‘‘par- ticularly suitable’’ for patients with acute MI, medi- cally refractory unstable angina, or symptomatic restenosis but advised against ad hoc PCI when ‘‘angiographic findings are unanticipated or the indica- tion, suitability, or preferences for percutaneous revas- cularization are unclear.’’27 The 2011 PCI guidelines2 do not specifically address ad hoc PCI but recommend for ACS patients and early invasive strategy that in most cases would include ad hoc PCI, particularly for patients with ongoing ischemia (Table T2II) (Fig. F11). Appropriate Use Criteria The 2012 Appropriate Use Criteria (AUC)3 classified PCI as appropriate, inappropriate, or of uncertain appro- priateness in a wide range of clinical scenarios based on four variables: clinical presentation [ST-segment eleva- tion MI (STEMI), non-ST elevation ACS (NSTE-ACS), or SIHD], extent and degree of ischemia suggested by J_ID: Z7V Customer A_ID: 12-1256 Cadmus Art: CCD24701 Date: 19-November-12 Stage: Page: 3 ID: guganp I Black Lining: [ON] I Time: 15:05 I Path: N:/3b2/CCD#/Vol00000/120481/APPFile/JW-CCD#120481 Ad Hoc PCI 3 Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI). 医 脉 通 ww w. me dl iv e. cn noninvasive testing before coronary angiography, ade- quacy of medical therapy, and extent of anatomic CAD. The document makes no explicit statement about ad hoc PCI but implies several principles. The AUC imply that ad hoc PCI is appropriate for many patients with ACS, particularly those with ongoing ischemia. The AUC also suggest that patients with stable moderate/severe angina who are optimally treated medically and have moderate/ high-risk findings on ischemic testing are generally suita- ble candidates for PCI, although they do not specify tim- ing. In contrast, the AUC suggest that, for patients with- out severe symptoms, prior functional testing confirming ischemia, and/or an attempt to provide optimal medical therapy, PCI is generally inappropriate. The AUC note that fractional flow reserve (FFR) or intravascular ultra- sound (IVUS) are acceptable substitutes for noninvasive testing before angiography to confirm that a target lesion is sufficiently severe to warrant PCI if a functional test was not performed before angiography.2,28,29 The AUC do not discuss timing of PCI, but a logical extension of the concept of appropriateness is that, when appropriate- ness of a procedure is uncertain, it should be delayed until indications are clarified. AD HOC PCI FOR SPECIFIC PATIENT SUBSETS ST-Segment Elevation Myocardial Infarction Ad hoc PCI of the infarct-related artery within 12 hr in symptomatic patients with STEMI has a class I indi- cation in the 2011 PCI guidelines.2 The 2011 PCI guidelines rate PCI of nonculprit lesions at the time of primary PCI as a class III recommendation2 due to evidence that the strategy increases adverse events.30 Cardiogenic Shock Revascularization decreases the mortality of STEMI patients with cardiogenic shock complicating ACS.31 Ad hoc PCI of the infarct artery is appropriate. Ad hoc PCI of more than one lesion may be appropriate if the culprit cannot be identified with certainty. Among patients with hemodynamic stabilization after PCI of the infarct artery, ad hoc PCI of noninfarct artery sten- oses correlates with poorer outcomes.32 If shock per- sists despite PCI of the culprit lesion, ad hoc PCI of nonculprit lesions may be helpful if they are flow lim- iting at rest and supply a large risk region.33 NSTE-ACS The 2011 PCI guidelines give a class I recommenda- tion for an early invasive strategy defined as diagnostic angiography with the intention to perform PCI for patients with NSTE-ACS who are at increased risk for clinical events or who have refractory angina, hemody- namic compromise, or electrical instability.2 While these guidelines do not specifically advocate ad hoc PCI in these situations, it is commonly used to provide the revascularization as recommended in these guide- lines. Plaque rupture apparent on angiography or IVUS may occur in multiple sites,34 warranting PCI of multi- ple lesions if the culprit cannot be identified or if more than one is suspected to be a culprit. Routine ad hoc PCI of nonculprit arteries in ACS may be of bene- fit.35–37 In a survey of 411 interventional cardiologists regarding PCI of nonculprit lesions in patients with ACS, 42% recommended ad hoc PCI, 37% recom- mended delayed PCI, and 14% recommended PCI of nonculprit lesions only if the patient experienced recur- rent ischemia after PCI of the culprit lesion.38 Stable Ischemic Heart Disease The 2011 PCI guidelines and 2012 AUC provide guidance for PCI in SIHD.2,3 In general, either ad hoc or delayed PCI is appropriate for symptom relief when patients are on optimal medical therapy, have symp- toms limiting their quality of life, have evidence of is- chemia in the target artery by stress testing or FFR, and have undergone informed consent. Among patients with SIHD, the AUC give the highest ratings of appro- priateness (8 or 9 on a scale of 1 to 9) to those with the most severe symptoms and largest areas of myocar- dium at risk. These patients are the most likely to ben- efit from PCI,25 and indications to perform ad hoc PCI TABLE II. Clinical Scenarios Favoring Delayed Percutaneous Coronary Intervention 1. High-risk/complex anatomic stable coronary disease (e.g., unpro- tected left main, complex multivessel coronary artery disease, chronic total occlusion). 2. Excessive contrast or radiation during diagnostic procedure or anticipated during percutaneous coronary intervention. 3. Site of service (e.g., facility without onsite surgery in which the patient risk or lesion risk is high or facility lacking necessary interventional equipment). 4. Inadequate informed consent (e.g., diagnostic catheterization identi- fies anatomy for which the risk of PCI is significantly higher than was discussed before percutaneous coronary intervention). 5. Uncertainty regarding extent of symptoms in patients with stable ischemic heart disease. 6. Lack of evidence of ischemia and unavailability of fractional flow reserve or intravascular ultrasound. 7. Complication during diagnostic catheterization (e.g., stroke and access site bleeding). 8. Operator or patient fatigue after diagnostic catheterization. 9. Scheduling problems (e.g., if a new patient presents with ST-elevation as ad hoc PCI is being considered for a patient with stable ischemic heart disease). 10. Inadequate pretreatment (e.g., no aspirin before diagnostic catheterization, inadequate trial of antianginal therapy, and inadequate hydration). J_ID: Z7V Customer A_ID: 12-1256 Cadmus Art: CCD24701 Date: 19-November-12 Stage: Page: 4 ID: guganp I Black Lining: [ON] I Time: 15:05 I Path: N:/3b2/CCD#/Vol00000/120481/APPFile/JW-CCD#120481 4 Blankenship et al. Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI). 医 脉 通 ww w. me dl iv e. cn are clearer than in patients with less severe symptoms or ischemia. Ad hoc PCI may be inappropriate if com- plications have occurred during the diagnostic catheter- ization, excessive radiation or contrast were used, the significance of a lesion cannot be determined, or a heart team approach is indicated t