2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST‐elevation myocardial Infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST‐elevation myocardial infarction: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions

To ensure that guidelines reflect current knowledge, available treatment options, and optimum medical care, existing clinical practice guideline recommendations are modified and new recommendations are added in response to new data, medications or devices. To keep pace with evolving evidence, the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Clinical Practice Guidelines (“Task Force”) has issued this focused update to revise guideline recommendations on the basis of recently published data. This update is not based on a complete literature review from the date of previous guideline publications, but it has been subject to rigorous, multilevel review and approval, similar to the full guidelines. For specific focused update criteria and additional methodological details, please see the ACC/AHA guideline methodology manual. 1 In response to published reports from the Institute of Medicine 2, 3 and ACC/AHA mandates, 4-7 processes have changed leading to adoption of a “knowledge byte” format. This entails delineation of recommendations addressing specific clinical questions, followed by concise text, with hyperlinks to supportive evidence. This approach better accommodates time constraints on busy clinicians, facilitates easier access to recommendations via electronic search engines and other evolving technology (eg, smart phone apps), and supports the evolution of guidelines as “living documents” that can be dynamically updated as needed. Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may inform regulatory or payer decisions, they are intended to improve quality of care in the interest of patients. The Class of Recommendation (COR) and Level of Evidence (LOE) are derived independently of one another according to established criteria. The COR indicates the strength of recommendation, encompassing the estimated magnitude and certainty of benefit of a clinical action in proportion to risk. The LOE rates the quality of scientific evidence supporting the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1). 1, 7, 8 The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All Guideline Writing Committee (GWC) members and reviewers are required to disclose current industry relationships or personal interests from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced GWC and assuring that the chair and a majority of committee members have no relevant RWI (Appendixes 1 and 2). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members’ comprehensive disclosure information is available. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. For additional information pertaining to the methodology for grading evidence, assessment of benefit and harm, shared decision making between the patient and clinician, structure of evidence tables and summaries, standardized terminology for articulating recommendations, organizational involvement, peer review, and policies for periodic assessment and updating of guideline documents, we encourage readers to consult the ACC/AHA guideline methodology manual. 1 The recommendations in this focused update represent the official policy of the ACC and AHA until superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles. 1 Jonathan L. Halperin, MD, FACC, FAHA Chair, ACC/AHA Task Force on Clinical Practice Guidelines The scope of this focused update is limited to considerations relevant to multivessel percutaneous coronary intervention (PCI) and thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. Clinical trials presented at the major cardiology organizations’ 2013 to 2015 annual scientific meetings and other selected reports published in a peer-reviewed format through August 2015 were reviewed by the 2011 PCI and 2013 STEMI GWCs and the Task Force to identify trials and other key data that might affect guideline recommendations. The information considered important enough to prompt updated recommendations is included in evidence tables in the Online Data Supplement (http://jaccjacc.acc.org/Clinical_Document/2015_Focused_Update_on_Primary_PCI_in_STEMI_Data_Supplements.pdf). Consult the full-text versions of the 2011 PCI and 2013 STEMI guidelines 9, 10 for recommendations in clinical areas not addressed in the focused update. The individual recommendations in this focused update will be incorporated into future revisions or updates of the full-text guidelines. For this focused update, representative members of the 2011 PCI and 2013 STEMI GWCs were invited to participate. Members were required to disclose all RWI relevant to the topics under consideration. The entire membership of both GWCs voted on the revised recommendations and text. The latter group was composed of experts representing cardiovascular medicine, interventional cardiology, electrophysiology, heart failure, cardiac surgery, emergency medicine, internal medicine, cardiac rehabilitation, nursing, and pharmacy. The GWC included representatives from the ACC, AHA, American College of Physicians, American College of Emergency Physicians, and Society for Cardiovascular Angiography and Interventions (SCAI). This document was reviewed predominantly by the prior reviewers from the respective 2011 and 2013 guidelines. These included 8 official reviewers jointly nominated by the ACC and AHA, 4 official/organizational reviewers nominated by SCAI, and 25 individual content reviewers. Reviewers’ RWI information was distributed to the GWC and is published in this document (Appendix 3). This document was approved for publication by the governing bodies of the ACC, the AHA, and the SCAI and was endorsed by the Latin American Society of Interventional Cardiology. (See Section 5.2.2.2 of 2011 PCI guideline and Section 4.1.1 of 2013 STEMI guideline for additional recommendations.) Approximately 50% of patients with STEMI have multivessel disease. 25, 26 PCI options for patients with STEMI and multivessel disease include: 1) culprit artery–only primary PCI, with PCI of nonculprit arteries only for spontaneous ischemia or intermediate- or high-risk findings on predischarge noninvasive testing; 2) multivessel PCI at the time of primary PCI; or 3) culprit artery–only primary PCI followed by staged PCI of nonculprit arteries. Observational studies, randomized controlled trials (RCTs), and meta-analyses comparing culprit artery–only PCI with multivessel PCI have reported conflicting results, 11, 12, 14-24, 27, 28 likely because of differing inclusion criteria, study protocols, timing of multivessel PCI, statistical heterogeneity, and variable endpoints (Data Supplement). Previous clinical practice guidelines recommended against PCI of nonculprit artery stenoses at the time of primary PCI in hemodynamically stable patients with STEMI. 9, 10 Planning for routine, staged PCI of noninfarct artery stenoses on the basis of the initial angiographic findings was not addressed in these previous guidelines, and noninfarct artery PCI was considered only in the limited context of spontaneous ischemia or high-risk findings on predischarge noninvasive testing. The earlier recommendations were based in part on safety concerns, which included increased risks for procedural complications, longer procedural time, contrast nephropathy, and stent thrombosis in a prothrombotic and proinflammatory state, 9, 10 and in part on the findings from many observational studies and meta-analyses of trends toward or statistically significant worse outcomes in those who underwent-multivessel primary PCI. 12-16, 21-23 Four RCTs have since suggested that a strategy of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure, may be beneficial and safe in selected patients with STEMI17, 18, 24, 27 (Data Supplement). In the PRAMI (Preventive Angioplasty in Acute Myocardial Infarction) trial (n=465), 24 the composite primary outcome of cardiac death, nonfatal myocardial infarction (MI), or refractory angina occurred in 21 patients (9%) treated with multivessel primary PCI, compared with 53 patients (22%) treated with culprit artery–only PCI (HR: 0.35; 95% CI: 0.21 to 0.58; P<0.001). In the CvLPRIT (Complete Versus Culprit-Lesion Only Primary PCI) trial, 18 296 patients were randomized to culprit artery–only or multivessel PCI during the index hospitalization (72% underwent multivessel primary PCI). The composite primary outcome of death, reinfarction, heart failure, and ischemia-driven revascularization at 12 months occurred in 15 patients (10%) who underwent multivessel PCI, compared with 31 patients (21%) receiving culprit artery–only PCI (HR: 0.49; 95% CI: 0.24 to 0.84; P=0.009). In the DANAMI 3 PRIMULTI (Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction) trial, 17 the composite primary outcome of all-cause death, nonfatal MI, or ischemia-driven revascularization of nonculprit artery disease occurred in 40 of 314 patients (13%) who underwent multivessel staged PCI guided by angiography and fractional flow reserve before discharge, versus 68 of 313 patients (22%) treated with culprit artery–only PCI (HR: 0.56; 95% CI: 0.38 to 0.83; P=0.004). In the PRAGUE-13 (Primary Angioplasty in Patients Transferred From General Community Hospitals to Specialized PTCA Units With or Without Emergency Thrombolysis) trial, 27 214 patients with STEMI were randomized to staged (3 to 40 days after the index procedure) revascularization of all ≥70% diameter stenosis noninfarct lesions or culprit-only PCI. Preliminary results at 38 months’ mean follow-up showed no between-group differences in the composite primary endpoint of all-cause death, nonfatal MI, and stroke. On the basis of these findings, 17, 18, 24, 27 the prior Class III (Harm) recommendation with regard to multivessel primary PCI in hemodynamically stable patients with STEMI has been upgraded and modified to a Class IIb recommendation to include consideration of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure. The writing committee emphasizes that this change should not be interpreted as endorsing the routine performance of multivessel PCI in all patients with STEMI and multivessel disease. Rather, when considering the indications for and timing of multivessel PCI, physicians should integrate clinical data, lesion severity/complexity, and risk of contrast nephropathy to determine the optimal strategy. The preceding discussion and recommendations apply to the strategy of routine PCI of noninfarct related arteries in hemodynamically stable patients. Recommendations in the 2013 STEMI guideline with regard to PCI of a non–infarct-related artery at a time separate from primary PCI in patients who have spontaneous symptoms and myocardial ischemia or who have intermediate- or high-risk findings on noninvasive testing (Section 6.3 of that guideline) remain operative. Although several observational studies 19, 20 and a network meta-analysis 13 have suggested that multivessel staged PCI may be associated with better outcome than multivessel primary PCI, there are insufficient observational data and no randomized data at this time to inform a recommendation with regard to the optimal timing of nonculprit vessel PCI. Additional trial data that will help further clarify this issue are awaited. Issues related to the optimal method of evaluating nonculprit lesions (eg, percent diameter stenosis, fractional flow reserve) are beyond the scope of this focused update. (See Section 5.5.2 of the 2011 PCI guideline and Section 4.2 of the 2013 STEMI guideline for additional recommendations.) The 2011 PCI and 2013 STEMI guidelines’ 9, 10 Class IIa recommendation for aspiration thrombectomy before primary PCI was based on the results of 2 RCTs 29, 31, 32 and 1 meta-analysis 30 and was driven in large measure by the results of TAPAS (Thrombus Aspiration During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction Study), a single-center study that randomized 1071 patients with STEMI to aspiration thrombectomy before primary PCI or primary PCI only. 29, 32 Three multicenter trials, 2 of which enrolled significantly more patients than prior aspiration thrombectomy trials, have prompted reevaluation of this recommendation. In the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial 37 of 452 patients with anterior STEMI due to proximal or mid-left anterior descending occlusion, infarct size was not reduced by aspiration thrombectomy before primary PCI. The TASTE (Thrombus Aspiration During ST-Segment Elevation Myocardial Infarction) trial (n=7244) incorporated a unique design that allowed randomization within an existing national registry, resulting in enrollment of a remarkably high proportion of eligible patients. 34, 36 No significant 30-day or 1-year differences were found between the group that received aspiration thrombectomy before primary PCI and the group that received primary PCI only with regard to death, reinfarction, stent thrombosis, target lesion revascularization, or a composite of major adverse cardiac events. The TOTAL (Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI) trial randomized 10,732 patients with STEMI to aspiration thrombectomy before primary PCI or primary PCI only. 35 Bailout thrombectomy was performed in 7.1% of the primary PCI–only group, whereas the rate of crossover from aspiration thrombectomy before primary PCI to primary PCI only was 4.6%. There were no differences between the 2 treatment groups, either in the primary composite endpoint of cardiovascular death, recurrent MI, cardiogenic shock, or New York Heart Association class IV heart failure at 180 days, or in the individual components of the primary endpoint, stent thrombosis, or target-vessel revascularization. There was a small but statistically significant increase in the rate of stroke in the aspiration thrombectomy group. An updated meta-analysis that included these 3 trials among a total of 17 trials (n=20 960) found no significant reduction in death, reinfarction, or stent thrombosis with routine aspiration thrombectomy. Aspiration thrombectomy was associated with a small but nonsignificant increase in the risk of stroke. 33 Several previous studies have found that higher thrombus burden in patients with STEMI is independently associated with higher risks of distal embolization, no-reflow phenomenon, transmural myocardial necrosis, major adverse cardiac events, stent thrombosis, and death. 38-42 However, subgroup analyses from the TASTE and TOTAL trials did not suggest relative benefit from aspiration thrombectomy before primary PCI in patients with higher thrombus burden or in patients with initial Thrombolysis in Myocardial Infarction (TIMI) flow grade 0–1 or left anterior descending artery/anterior infarction. 34, 35 On the basis of the results of these studies, the prior Class IIa recommendation for aspiration thrombectomy has been changed. Routine aspiration thrombectomy before primary PCI is now not recommended (Class III: No Benefit, LOE A). There are insufficient data to assess the potential benefit of a strategy of selective or bailout aspiration thrombectomy (Class IIb, LOE C-LD). “Bailout” aspiration thrombectomy is defined as thrombectomy that was initially unplanned but was later used during the procedure because of unsatisfactory initial result or procedural complication, analogous to the definition of “bailout” glycoprotein IIb/IIIa use. It should be noted that the preceding recommendations and text apply only to aspiration thrombectomy; no clinical benefit for routine rheolytic thrombectomy has been demonstrated in patients with STEMI undergoing primary PCI. 30, 43, 44 Presidents and Staff American College of Cardiology Kim A. Williams, Sr, MD, FACC, FAHA, President Shalom Jacobovitz, Chief Executive Officer William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publications Amelia Scholtz, PhD, Publications Manager, Science, Education, and Quality American College of Cardiology/American Heart Association Lisa Bradfield, CAE, Director, Science and Clinical Policy Abdul R. Abdullah, MD, Associate Science and Medicine Advisor Allison Rabinowitz, Project Manager, Science and Clinical Policy American Heart Association Mark A. Creager, MD, FAHA, FACC, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FAHA, Chief Science Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations Class III: No Benefit Routine aspiration thrombectomy before primary PCI is not useful.33-37 (Level of Evidence: A) • Merck • Sanofi-aventis • Abbott Vascularb • Abiomedb • Boston Scientificb • Volcanob • Abbott • Boston Scientific • Medtronic • Medtronic • St. Jude Medical • Abbottc • Boston Scientificc • Bristol-Myers Squibbc • Cordisc • Medtronic Cardiovascularc • Sanofi-aventisc • Abbott Vascular • Boston Scientific • Janssen (Johnson & Johnson)c • Merck • Sanofi-aventisc • BMS/Sanofi-aventisc • Regado • STENTYSb • Boston Scientificd • Medtronicd • St. Jude Medicald • Biosense Websterd • Boston Scientificd • Medtronicd • St. Jude Medicalc • Abbott Diagnostics • Novo Nordisc • St. Jude Medical • Medtronic Foundationc • Merckc • Johnson & Johnsonc • Medtronicc • Abbott • Merck • Abbottc • GlaxoSmithKlinec • Johnson & Johnsonc • Merckc • St. Jude Medicald • Medtronicd