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2009 Focused Updates

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2009 Focused Updates

    2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous (经皮)Coronary

    Intervention?介入? (Updating the 2005 Guideline and 2007 Focused Update)?更新?

    A Report of the American College of Cardiology

    Foundation/American Heart Association Task Force on Practice Guidelines

    Frederick G. Kushner, MD, FACC, FAHA, FSCAI, Co-Chair; Mary Hand, MSPH, *RN, FAHA, Co-Chair; Sidney C. Smith, Jr, MD, FACC, FAHA, Chair; Spencer B. King, III, MD, MACC, FSCAI, Co-Chair; Jeffrey L. Anderson, MD, FACC, FAHA; Elliott M. Antman, MD, FACC, FAHA; Steven R. Bailey, MD, FACC, FSCAI; Eric R. Bates, MD, FACC, FAHA; James C. Blankenship, MD, FACC, FSCAI; Donald E. Casey, Jr, MD, MPH, MBA; Lee A. Green, MD, MPH; Judith S. Hochman, MD, FACC, FAHA; Alice K. Jacobs, MD, FACC, FAHA, FSCAI; Harlan M. Krumholz, MD, SM, FACC, FAHA; Douglass A. Morrison, MD, PhD, FACC, FSCAI; Joseph P. Ornato, MD, FACC, FAHA; David L. Pearle, MD, FACC, FAHA; Eric D. Peterson, MD, MPH, FACC, FAHA; Michael A. Sloan, MD, MS, FACC, FAHA; Patrick L. Whitlow, MD, FACC, FAHA; David O. Williams, MD, FACC, FAHA, FSCAI

Key Words: ACCF/AHA practice guidelines?实践指南? • focused update •

    ST-elevation myocardial infarction • percutaneous coronary intervention • thienopyridines?噻吩并吡啶? • parenteral?肠外? anticoagulants

    ?抗凝血药? • antiplatelet therapy • glycoprotein?糖蛋白? IIb/IIIa

    receptor antagonists ?拮抗剂?

     2009 STEMI and PCI Focused Updates...2273 Preamble(前言)...2273

     1. Introduction...2274 1.1.Methodology?方法论? and EvidenceReview?回顾?...2274 1.2.Organization of Committeeand Relationships With Industry andOther Entities?实体?2275

     1.3.Document Review andApproval?审批?...2275

     STEMI and PCI FocusedUpdate Section...2276

     2.Recommendations?建议? forthe Use of GlycoproteinIIb/IIIa

     ReceptorAntagonists...2276 2.1.Glycoprotein IIb/IIIaReceptor Antagonists...2276

     3.Recommendationsfor the Use of Thienopyridines...2277 3.1.Thienopyridines...2277 3.1.1. Additional Thienopyridine Information...2280 3.1.2.Choice of Thienopyridine for PCI in STEMI...2281

     3.2.Proton?质子? Pump Inhibitorsand Dual-Antiplatelet Therapy for ACS...2281

     4. Recommendations for the Use of Parenteral

    Anticoagulants...2282 4.1.Parenteral Anticoagulants...2282

     5. Recommendationsfor Triage?分流? and Transferfor PCI...2283 5.1.Triageand Transferfor PCI...2283 5.1.1.STEMI Patients Who Are Candidates for Reperfusion ?再灌注?...2283

     6. Recommendations for Intensive Glucose?葡萄糖?Controlin STEMI...2286 6.1.IntensiveGlucose Control...2286

     ?? 7. Recommendationfor Thrombus?血栓? Aspiration心愿During PCI for STEMI...2287 7.1.Thrombus Aspiration...2287

     8. Recommendationsfor the Use of Stents inSTEMI...2288 8.1.StentSelection forSTEMI...2288

     PCI Focused UpdateSection...2289

     9. Recommendationfor Angiography?血管造影?in PatientsWith

     Chronic Kidney Disease...2289 9.1.Angiography in PatientsWith Chronic Kidney Disease...2289

     10.Recommendations for Use of Fractional?分数?Flow?流动?

    ...2289 Reserve?储留? 10.1.Fractional Flow Reserve...2289

     11. Recommendationsfor PCI for UnprotectedLeft Main Coronary Artery Disease...2290 11.1.Unprotected Left MainCoronary Artery Disease...2290

     12. Recommendationsfor the Timing of Angiographyand Antiplatelet Therapy in UA/NSTEMI...2292 12.1.Timing of Angiography...2292 12.2.Timing of GP IIb/IIIaReceptor Antagonist Therapy in

     UA/NSTEMIPatients Undergoing?经历?Angiography...2292

     Appendix 1. Author RelationshipsWith Industry and Other EntitiesST-ElevationMyocardialInfarction...2294 Appendix 2. Author Relationships With Industryand Other EntitiesPercutaneousCoronary Intervention...2295 Appendix 3. Reviewer Relationships With Industry and Other Entities2009STEMI and PCI Focused Updates...2296 Appendix4. Dosing Table for Antiplatelet and AnticoagulantTherapy Discussedin This Focused Update to Support PCI in STEMI...2299 Appendix5. Triage and Transfer for PCI...2301 Appendix 6. Outcomesof PCI Versus CABG for Unprotected LeftMain Coronary ArteryDisease...2301 References...2302

    Preamble?前言? A primary challenge in the development of clinical practiceguidelines is keeping pace with the stream of new data on whichrecommendations are based. In an effort to respond promptlyto new evidence, the American College of Cardiology Foundation/AmericanHeart Association (ACCF/AHA) Task Force on Practice Guidelineshas created a "focused update" process to revise the existingguideline recommendations that are affected by evolving dataor opinion. Before the initiation of this focused approach,periodic ?定期?updates and revisions?修改? of existing guidelines requiredup to 3 years to complete. Now, however, new evidence will be reviewed in an ongoing fashion to more efficiently respond toimportant science and treatment trends that could have a majorimpact on patient outcomes and quality of care. Evidence willbe reviewed at least twice a year, and updates will be initiatedon an as-needed basis as quickly as possible, while maintainingthe rigorous?严格? methodology that the ACCF and AHA have developedduring their 25 years of partnership.

     These updated guideline recommendations reflect a consensus?共识?of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting?审批? process as being important to the relevant?相关? patient population, as well as a review of other new data deemed to have an impact on patientcare (see Section 1.1, Methodology and Evidence Review, fordetails). This focused update is not intended to represent anupdate based on a full literature review from the date of theprevious guideline publication. Specific criteria/considerationsfor inclusion of new data include the following:

     1. publicationin a peer-reviewed journal; 2. large randomized, placebo-controlledtrial(s); 3. nonrandomized data deemed important on the basisof resultsthat affect current safety and efficacy assumptions; 4. strength/weakness of research methodology and findings; 5. likelihoodof additional studies influencing current findings; 6. impacton current performance measure(s) and/or likelihood ofneed to develop new performance measure(s); 7. requests and requirementsfor review and update from the practice community, key stakeholders,and other sources free of relationshipswith industry or otherpotential bias; 8. number of previous trials showing consistentresults; and 9. need for consistency with a new guideline orguideline revision.

     In analyzing the data and developing updated recommendationsand supporting text, the focused update writing group used evidence-based

     methodologies developed by the ACCF/AHA Task Force on PracticeGuidelines, 1 which are described elsewhere.

     The schema?框架? for classification of recommendations and level of evidence is summarized in Table 1, which also illustrates howthe grading system provides an estimate of the size of the treatmenteffect and an estimate of the certainty of the treatment effect.Note that a recommendation with level of evidence B or C doesnot imply that the recommendation is weak. Many important clinicalquestions addressed in guidelines do not lend themselves toclinical trials. Although randomized trials may not be available,there may be a very clear clinical consensus that a particulartest or therapy is useful and effective. Both the classificationof recommendations and level of evidence listed in the focusedupdates are based on consideration of the evidence reviewedin previous iterations of the guideline and the focused update.Of note, the implications of older studies that have informedrecommendations but have not been repeated in contemporary settingsare considered carefully.

    Table 1. Applying Classification of Recommendations and Level of Evidence

    *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history

     of prior myocardial infarction, history of heart failure, and prior aspirin use. View larger version (66K):

    A recommendation with Level of Evidence [in this window]

    B or C does not imply that the [in a new window]

    recommendation is weak. Many important

    clinical questions addressed in the

    guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a

    very clear clinical consensus that a particular test or therapy is useful or effective.

    In 2003, the ACCF/AHA Task Force on Practice Guidelines developed a list of

    suggested phrases to use when writing

recommendations. All guideline

    recommendations have been written in full sentences that express a complete thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level.

     The ACCF/AHA practice guidelines address patient populations(and healthcare providers) residing in North America. As such,drugs that are not currently available in North America arediscussed in the text without a specific class of recommendation.For studies performed in large numbers of subjects outside ofNorth America, each writing group reviews the potential impactof different practice patterns and patient populations on thetreatment effect and on the relevance to the ACCF/AHA target population to determine whether the findings should inform aspecific recommendation.

     The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a rangeof generally acceptable approaches for the diagnosis, management,and prevention of specific diseases or conditions. The guidelinesattempt to define practices that meet the needs of most patientsin most circumstances. The ultimate judgment regarding careof a particular patient must be made by the healthcare providerand patient in light of all the circumstances presented by thatpatient. Thus, there are circumstances in which deviations fromthese guidelines may be appropriate. Clinical decision makingshould consider the quality and availability of expertise inthe area where care is provided. These guidelines may be usedas the basis for regulatory or payer decisions, but the ultimategoals are quality of care and serving the patient’s bestinterests.

     Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed by the patient. Becausea lack of patient adherence may adversely affect treatment outcomes,healthcare providers should engage the patient in active participationwith the prescribed treatment.

     The ACCF/AHA Task Force on Practice Guidelines makes every effortto avoid actual, potential, or perceived conflicts of interestthat may arise as a result of industry relationships or personalinterests among the writing committee. Specifically, all membersof the writing committee, as well as reviewers of the document,are asked to disclose all such relevant relationships pertainingto the trials and other evidence under consideration (see Appendixes1, 2, and 3). All guideline recommendations require a confidentialvote by the writing group and must be approved by a consensusof the members voting. Members who recused themselves from votingare noted on the title page of this document. Members must recuse themselves from voting on any recommendations to which their relationships with industry and other entities apply. Writinggroup members who did not participate are not listed as authorsof this focused update. The work of the writing group was supportedexclusively by the ACCF and AHA without commercial support.Writing group members volunteered their time for this effort.

     With the exception of the recommendations presented here, thefull-text 2,3 guidelines remain current. Only the recommendationsfrom the affected section(s) of the full-text guidelines areincluded in this focused update. Recommendations from any sectionof a guideline affected by a change are presented with notationas to whether they are new or have been modified; however, recommendationsthat remain unchanged in each section are not included in thisfocused update. When evidence affects recommendations in morethan 1 set of guidelines, those guidelines are updated concurrentlywhenever possible.

     The recommendations in this focused update will be consideredcurrent until they are superseded by another focused updateor the full-text guidelines are revised. This focused updateis published in the December 1, 2009, issues of the Journalof the American College of Cardiology and Circulation as anupdate to the full-text guideline, and it is also posted onthe American College of Cardiology (ACC; www.acc.org), AHA (my.americanheart.org),and Society for Cardiovascular Angiography and Interventions(SCAI; scai.org) World Wide Web sites.

     Alice K. Jacobs, MD, FACC, FAHA

     Chair, ACCF/AHA Task Force on Practice Guidelines 1. Introduction

    1.1. Methodology and Evidence Review

     Late-breaking clinical trials presented at the 2007 and 2008annual scientific meetings of the ACC, AHA, Transcatheter Cardiovascular Therapeutics, the European Society of Cardiology, and the 2009annual

scientific sessions of the ACC were reviewed by the standingguideline writing committee along with the parent Task Forceand other experts to identify those trials and other key datathat may impact guideline recommendations. On the basis of thecriteria/considerations noted above, recent trial data and otherclinical information were considered important enough to prompta focused update of the ACC/AHA 2004 Guidelines for the Managementof Patients With ST-Elevation Myocardial Infarction theACC/AHA 2005 Guidelines for Percutaneous Coronary Intervention,and 25 inclusive of their respective 2007 focused updates.

The ST-elevation myocardial infarction (STEMI) and percutaneouscoronary intervention (PCI) writing groups together consideredthe following studies: Two meta-analyses, "A Comparison of Abciximaband Small Molecule Glycoprotein IIb/IIIa Inhibitors in PatientsUndergoing Primary 6 Percutaneous Coronary Intervention," and"Benefits From Small Molecule Administration as Compared WithAbciximab Among Patients With ST-Segment 7Elevation MyocardialInfarction Treated With Primary Angioplasty," FINESSE (FacilitatedPCI in Patients With ST-Elevation Myocardial 8 Infarction), theHORIZONS-AMI (Harmonizing Outcomes With 9Revascularization andStents in Acute Myocardial Infarction), BRAVE-3 10(Bavarian ReperfusionAlternatives Evaluation-3), MULTISTRATEGY (Multicentre Evaluationof Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-ElutingStent or Bare Metal Stent in Acute 11Myocardial Infarction Study), ON-TIME 2 (Ongoing Tirofiban in Myocardial 12Infarction Evaluation), TRITON-TIMI 38 (Trial to Assess Improvement in TherapeuticOutcomes by Optimizing Platelet Inhibition With 13PrasugrelThrombolysisin Myocardial Infarction), TRANSFER-AMI (Trial of RoutineANgioplasty and Stenting after Fibrinolysis to Enhance 14Reperfusionin Acute Myocardial Infarction), CARESS-in-AMI (Combined 15AbciximabReteplase Stent Study in Acute Myocardial Infarction), NICE-SUGAR(Normoglycemia in Intensive Care EvaluationSurvival Using16 Glucose Algorithm Regulation), TAPAS (Thrombus Aspirationduring Percutaneous coronary intervention in Acute myocardialinfarction 17 Study), and EXPIRA (Thrombectomy With Export Catheterin Infarct-Related 18Artery During Primary Percutaneous CoronaryIntervention). Additionally, the PCI writing group consideredthe CARE (Cardiac Angiography in Renally 19Impaired Patients), FAME (Fractional Flow Reserve versus Angiography for 20MultivesselEvaluation) study, SYNTAX (Synergy Between Percutaneous 21InterventionWith Taxus and Cardiac Surgery), Early ACS (Early versus 22 Delayed,Provisional Eptifibatide in Acute Coronary Syndromes), and TIMACS (Timing of Intervention in Patients With Acute CoronarySyndromes) 23 studies. When considering the new data for thisfocused update, the writing group faced the task of weighingevidence from studies that had enrolled large numbers of subjectsoutside North America. Although noting

     that practice patternsand the rigor applied to data collection, as well as the geneticmakeup of subjects, may influence the observed magnitude ofa treatment’s effect, the writing group believed the datawere relevant to the formulation of recommendations for managementof STEMI and PCI in North America. The writing group also notesthat the AHA/ACCF and the Heart Rhythm Society have publishedupdated recommendations for the standardization and interpretationof the electrocardiogram with a 24 separate section on acute ischemia/infarction.

     To provide clinicians with a comprehensive set of data, wheneverpossible, the exact event rates in various treatment arms ofclinical trials are presented to permit calculation of the absoluterisk difference and number needed to treat (NNT) or harm; therelative treatment effects are described either as odds ratio,relative risk (RR), or hazard ratio (HR) depending on the formatused in the original publication. Along with all other statisticalpoint estimates, the confidence interval (CI) for those statisticsare added when available.

     Consult the full-text or executive summary versions of the ACC/AHA2004 Guidelines for the Management of Patients With ST-ElevationMyocardial Infarction or the ACC/AHA/SCAI 2005 Guidelines forPercutaneous Coronary Intervention, as well as their respective2007 focused updates, for policy 25on clinical areas not coveredby the present focused update. Unchanged recommendationsfrom previous iterations of the guidelines are not listed inthis document and remain current policy. Individual recommendations updated in this focused update will be incorporated into futurerevisions of the full-text guidelines.

    1.2. Organization of Committee and Relationships With Industry and Other Entities

     For this focused update, all members of the 2004 STEMI guideline,2007 STEMI focused update, 2005 PCI guideline, and 2007 PCIfocused update writing committees were invited to participate;those who agreed (referred to as the 2009 Focused Update WritingGroup) were required to disclose all relationships with industryand other entities relevant to the data under consideration.The policies used for relationships with industry were thosein effect at the initial meeting of this committee, which includeddisclosure of relationships 12 months prior to initiation anda chair with no relevant relationships except in a situationwhere more than one chair is named. In this circumstance, onechair will have no relevant relationships and the other mayhave relationships. Each recommendation required a confidentialvote by the writing group members before and after externalreview of the document. Any writing group member with a relationshipwith industry relevant to the recommendation was recused fromvoting on that recommendation. The PCI writing group included 2 representatives from SCAI.

     1.3. Document Review and Approval

     This document was reviewed by 3 official reviewers nominatedby the ACCF and 4 official reviewers nominated by the AHA, 1official reviewer nominated by the SCAI, 6 reviewers from theACCF Interventional Council, 2 reviewers from the ACCF ImagingCouncil, and 22 content reviewers. All reviewer informationon relationships with industry and other entities was collectedand distributed to the writing committee and is published inAppendix 3. This document was approved for publication by thegoverning bodies of the ACCF, the AHA, and the SCAI (specifically,the PCI portion of the guideline).

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    Introduction

    2009 STEMI and PCI...

    STEMI and PCI Focused...

    PCI Focused Update Section

    Staff

    References

     STEMI and PCI Focused Update Section

    2. Recommendations for the Use of Glycoprotein IIb/IIIa Receptor

    Antagonists (See Table 2 and Appendix 4.)

View this Table 2. Recommendations for the Use of Glycoprotein

    table: IIb/IIIa Receptor Antagonists

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