2015 acc/aha/scai focused update on primary ...2015 acc/aha/scai focused update on primary pci march...

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P U B L I S H E D B Y E L S E V I E R

FOCUSED UPDATE

2015 ACC/AHA/SCAI FocusedUpdate on Primary PercutaneousCoronary Intervention for Patients
With ST-Elevation Myocardial Infarction
An Update of the 2011 ACCF/AHA/SCAI Guidelinefor Percutaneous Coronary Intervention and the2013 ACCF/AHAGuideline for the Management ofST-Elevation Myocardial Infarction

Endorsed by the Latin American Society of Interventional Cardiology

PCI WritingCommittee*

Glenn N. Levine, MD, FACC, FAHA, ChairyEric R. Bates, MD, FACC, FAHA, FSCAI, Vice Ch
air*yJames C. Blankenship, MD, FACC, FAHA, FSCAI,Vice Chair*z
Steven R. Bailey, MD, FACC, FSCAI*zJohn A. Bittl, MD, FACCyBojan Cercek, MD, FACC, FAHAyCharles E. Chambers, MD, FACC, FSCAIzStephen G. Ellis, MD, FACC*yRobert A. Guyton, MD, FACCxSteven M. Hollenberg, MD, FACC*yUmesh N. Khot, MD, FACC*y

Richard A. Lange, MD, FACC, FAHAyLaura Mauri, MD, MSC, FACC, FSCAI*yRoxana Mehran, MD, FACC, FAHA, FSCAI*zIssam D. Moussa, MD, FACC, FAHA, FSCAIzDebabrata Mukherjee, MD, FACC, FAHA, FSCAIyHenry H. Ting, MD, FACC, FAHAy

*Writing committee members are required to recuse themselves from

voting on sections to which their specific relationships with industry may

apply; see Appendixes 1 and 2 for detailed information. yACC/AHA

Representative. zSCAI Representative. xACC/AHA Task Force on Clinical

Practice Guidelines Liaison.

STEMI WritingCommittee*

Patrick T. O’Gara, MD, FACC, FAHA, ChairyFrederick G. Kushner, MD, FACC, FAHA, FSCAI
,Vice Chairy
Deborah D. Ascheim, MD, FACCkRalph G. Brindis, MD, MPH, MACC, FSCAI, FAHAxDonald E. Casey, JR, MD, MPH, MBA, FAHA{Mina K. Chung, MD, FACC, FAHA*yJames A. de Lemos, MD, FACC*yDeborah B. Diercks, MD, MSc#James C. Fang, MD, FACC, FAHA*yBarry A. Franklin, PhD, FAHAyChristopher B. Granger, MD, FACC, FAHA*yHarlan M. Krumholz, MD, SM, FACC, FAHA*yJane A. Linderbaum, MS, CNP-BCy

David A. Morrow, MD, MPH, FACC, FAHA*yL. Kristin Newby, MD, MHS, FACC, FAHA*yJoseph P. Ornato, MD, FACC, FAHA, FACP, FACEP*yNarith Ou, PharmDyMartha J. Radford, MD, FACC, FAHAyJacqueline E. Tamis-Holland, MD, FACC, FSCAIyCarl L. Tommaso, MD, FACC, FAHA, MSCAIzCynthia M. Tracy, MD, FACC, FAHAyY. Joseph Woo, MD, FACC, FAHAyDavid X. Zhao, MD, FACC*y

kDr. Deborah D. Ascheim accepted a position at Capricor Therapeutics in

August 2015, after the writing effort was completed. In accordance with

ACC/AHA policy, she recused herself from the final voting process. {ACPRepresentative. #ACEP Representative.

http://crossmark.crossref.org/dialog/?doi=10.1016/j.jacc.2015.10.005&domain=pdf

http://dx.doi.org/10.1016/j.jacc.2015.10.005

Levine et al. J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6

2015 ACC/AHA/SCAI Focused Update on Primary PCI M A R C H 1 5 , 2 0 1 6 : 1 2 3 5 – 5 0

1236

ACC/AHA TaskForce Members

Jonathan L. Halperin, MD, FACC, FAHA, CGlenn N. Levine, MD, FACC, FAHA, Chair-

This document was ap

and Coordinating Comm

Committee in October 2

The American College

Bailey SR, Bittl JA, Brin

Hollenberg SM, Khot UN

MJ, Tamis-Holland JE, T

patients with ST-elevati

guideline for the mana

Clinical Practice Guideli

This article has been

Copies: This docume

americanheart.org), and

prints Department via f

Permissions: Multiple

American College of Car

material).

hairElect

Jeffrey L. Anderson, MD, FACC, FAHA,Immediate Past Chair**

Nancy M. Albert, PhD, RN, FAHA**
Sana M. Al-Khatib, MD, MHS, FACC, FAHAKim K. Birtcher, PharmD, MS, AACCBiykem Bozkurt, MD, PhD, FACC, FAHARalph G. Brindis, MD, MPH, MACCJoaquin E. Cigarroa, MD, FACCLesley H. Curtis, PhD, FAHALee A. Fleisher, MD, FACC, FAHAFederico Gentile, MD, FACC
proved by the American College of Cardiology Board of Trustees and Ex

ittee, and the Society of Cardiovascular Angiography and Interventions

015.

of Cardiology requests that this document be cited as follows: Levine

dis RG, Casey DE Jr, Cercek B, Chambers CE, Chung MK, de Lemos JA,

, Krumholz HM, Lange RA, Linderbaum JA, Mauri L, Mehran R, Morrow

ing HH, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCA

on myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guide

gement of ST-elevation myocardial infarction: a report of the America

nes and the Society for Cardiovascular Angiography and Interventions

copublished in Circulation and Catheterization and Cardiovascular Inte

nt is available on the World Wide Web sites of the American College

the Society for Cardiovascular Angiography and Interventions (www

ax (212) 633-3820, or e-mail [email protected].

copies, modification, alteration, enhancement, and/or distribution of t

diology. Requests may be completed online via the Elsevier site (http:/

Samuel Gidding, MD, FAHAMark A. Hlatky, MD, FACCJohn Ikonomidis, MD, PhD, FAHAJose Joglar, MD, FACC, FAHARichard J. Kovacs, MD, FACC, FAHA**E. Magnus Ohman, MD, FACC**Susan J. Pressler, PhD, RN, FAHAFrank W. Sellke, MD, FACC, FAHA**Win-Kuang Shen, MD, FACC, FAHA**Duminda N. Wijeysundera, MD, PhD

**Former Task Force member; current member during the writing

effort.

TABLE OF CONTENTS

PREAMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1236

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1237

1.1. Methodology and Evidence Review . . . . . . . . . . . 1237

1.2. Organization of the GWC . . . . . . . . . . . . . . . . . . . 1338

1.3. Review and Approval . . . . . . . . . . . . . . . . . . . . . . 1238

2. CULPRIT ARTERY–ONLY VERSUS MULTIVESSEL

PCI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1239

3. ASPIRATION THROMBECTOMY . . . . . . . . . . . . . . . . 1240

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1241

APPENDIX 1

Author Relationships With Industry and Other Entities(Relevant) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1243

APPENDIX 2

Author Relationships With Industry and Other Entities(Relevant) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1245

APPENDIX 3

Reviewer Relationships With Industry and OtherEntities (Relevant)—2015 Focused Update on PrimaryPercutaneous Coronary Intervention for PatientsWith ST-Elevation Myocardial Infarction (CombinedPeer Reviewers From 2011 PCI and 2013 STEMIGuidelines) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1247

PREAMBLE

To ensure that guidelines reflect current knowledge,available treatment options, and optimum medical care,existing clinical practice guideline recommendations aremodified and new recommendations are added inresponse to new data, medications or devices. To keeppace with evolving evidence, the American College

ecutive Committee, the American Heart Association Science Advisory

in September 2015, and by the American Heart Association Executive

GN, O’Gara PT, Bates ER, Blankenship JC, Kushner FG, Ascheim DD,

Diercks DB, Ellis SG, Fang JC, Franklin BA, Granger CB, Guyton RA,

DA, Moussa ID, Mukherjee D, Newby LK, Ornato JP, Ou N, Radford

I focused update on primary percutaneous coronary intervention for

line for percutaneous coronary intervention and the 2013 ACCF/AHA

n College of Cardiology/American Heart Association Task Force on

. J Am Coll Cardiol 2016;67:1235–50.

rventions.

of Cardiology (www.acc.org), the American Heart Association (my.

.scai.org). For copies of this document, please contact Elsevier Re-

his document is not permitted without the express permission of the

/www.elsevier.com/authors/obtainingpermission-to-re-use-elsevier-

http://www.acc.org

http://my.americanheart.org

http://my.americanheart.org

http://www.scai.org

mailto:[email protected]

http://www.elsevier.com/authors/obtainingpermission-to-re-use-elsevier-material

http://www.elsevier.com/authors/obtainingpermission-to-re-use-elsevier-material

J A C C V O L . 6 7 , N O . 1 0 , 2 0 1 6 Levine et al.M A R C H 1 5 , 2 0 1 6 : 1 2 3 5 – 5 0 2015 ACC/AHA/SCAI Focused Update on Primary PCI

1237

of Cardiology (ACC)/American Heart Association (AHA)Task Force on Clinical Practice Guidelines (“Task Force”)has issued this focused update to revise guideline rec-ommendations on the basis of recently published data.This update is not based on a complete literature reviewfrom the date of previous guideline publications, but it hasbeen subject to rigorous, multilevel review and approval,similar to the full guidelines. For specific focused updatecriteria and additional methodological details, please seethe ACC/AHA guideline methodology manual (1).

Modernization

In response to published reports from the Institute ofMedicine (2,3) and ACC/AHA mandates (4–7), processeshave changed leading to adoption of a “knowledge byte”format. This entails delineation of recommendationsaddressing specific clinical questions, followed by concisetext, with hyperlinks to supportive evidence. Thisapproach better accommodates time constraints on busyclinicians, facilitates easier access to recommendationsvia electronic search engines and other evolving tech-nology (e.g., smart phone apps), and supports the evolu-tion of guidelines as “living documents” that can bedynamically updated as needed.

Intended Use

Practice guidelines provide recommendations applicable topatients with or at risk of developing cardiovascular disease.The focus is on medical practice in the United States, butguidelines developed in collaboration with other organiza-tions may have a broader target. Although guidelines mayinform regulatory or payer decisions, they are intended toimprove quality of care in the interest of patients.

Class of Recommendation and Level of Evidence

The Class of Recommendation (COR) and Level of Evi-dence (LOE) are derived independently of one anotheraccording to established criteria. The COR indicates thestrength of recommendation, encompassing the esti-mated magnitude and certainty of benefit of a clinicalaction in proportion to risk. The LOE rates the quality ofscientific evidence supporting the intervention on thebasis of the type, quantity, and consistency of data fromclinical trials and other sources (Table 1) (1,7,8).

Relationships With Industry and Other Entities

The ACC and AHA sponsor the guidelines without com-mercial support, and members volunteer their time. TheTask Force zealously avoids actual, potential, orperceived conflicts of interest that might arise throughrelationships with industry or other entities (RWI). AllGuideline Writing Committee (GWC) members and re-viewers are required to disclose current industry re-lationships or personal interests from 12 months before

initiation of the writing effort. Management of RWI in-volves selecting a balanced GWC and assuring that thechair and a majority of committee members have norelevant RWI (Appendixes 1 and 2). Members arerestricted with regard to writing or voting on sections towhich their RWI apply. For transparency, members’comprehensive disclosure information is available online.Comprehensive disclosure information for the Task Forceis also available online. The Task Force strives to avoidbias by selecting experts from a broad array of back-grounds representing different geographic regions, sexes,ethnicities, intellectual perspectives/biases, and scopes ofclinical practice, and by inviting organizations and pro-fessional societies with related interests and expertise toparticipate as partners or collaborators.

Related Issues

For additional information pertaining to the methodologyfor grading evidence, assessment of benefit and harm,shared decision making between the patient and clini-cian, structure of evidence tables and summaries, stan-dardized terminology for articulating recommendations,organizational involvement, peer review, and policies forperiodic assessment and updating of guideline docu-ments, we encourage readers to consult the ACC/AHAguideline methodology manual (1).

The recommendations in this focused update representthe official policy of the ACC and AHA until superseded bypublished addenda, statements of clarification, focused up-dates, or revised full-text guidelines. To ensure that guide-lines remain current, new data are reviewed biannually todetermine whether recommendations should be modified. Ingeneral, full revisions are posted in 5-year cycles (1).

Jonathan L. Halperin, MD, FACC, FAHAChair, ACC/AHA Task Force on Clinical Practice Guidelines

1. INTRODUCTION

The scope of this focused update is limited to consider-ations relevant to multivessel percutaneous coronaryintervention (PCI) and thrombus aspiration in patientswith ST-elevation myocardial infarction (STEMI) under-going primary PCI.

1.1. Methodology and Evidence Review

Clinical trials presented at the major cardiology organi-zations’ 2013 to 2015 annual scientific meetings and otherselected reports published in a peer-reviewed formatthrough August 2015 were reviewed by the 2011 PCIand 2013 STEMI GWCs and the Task Force to identifytrials and other key data that might affect guideline rec-ommendations. The information considered importantenough to prompt updated recommendations is includedin evidence tables in the Online Data Supplement.

http://jaccjacc.acc.org/Clinical_Document/2015_Focused_Update_on_Primary_PCI_in_STEMI_Comprehensive_RWI_Table.pdf

http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/guidelines-and-documents-task-forces

http://jaccjacc.acc.org/Clinical_Document/2015_Focused_Update_on_Primary_PCI_in_STEMI_Data_Supplements.pdf

TABLE 1Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments,or Diagnostic Testing in Patient Care* (Updated August 2015)



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Consult the full-text versions of the 2011 PCI and 2013STEMI guidelines (9,10) for recommendations in clinicalareas not addressed in the focused update. The individualrecommendations in this focused update will be incor-porated into future revisions or updates of the full-textguidelines.

1.2. Organization of the GWC

For this focused update, representative members ofthe 2011 PCI and 2013 STEMI GWCs were invited to partic-ipate. Members were required to disclose all RWI relevantto the topics under consideration. The entire membershipof both GWCs voted on the revised recommendations andtext. The latter group was composed of experts represent-ing cardiovascular medicine, interventional cardiology,

electrophysiology, heart failure, cardiac surgery, emer-gency medicine, internal medicine, cardiac rehabilitation,nursing, and pharmacy. The GWC included representativesfrom the ACC, AHA, American College of Physicians,American College of Emergency Physicians, and Society forCardiovascular Angiography and Interventions (SCAI).

1.3. Review and Approval

This document was reviewed predominantly by the priorreviewers from the respective 2011 and 2013 guidelines.These included 8 official reviewers jointly nominatedby the ACC and AHA, 4 official/organizational reviewersnominated by SCAI, and 25 individual content reviewers.Reviewers’ RWI information was distributed to the GWCand is published in this document (Appendix 3).


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This document was approved for publication by thegoverning bodies of the ACC, the AHA, and the SCAI andwas endorsed by the Latin American Society of Interven-tional Cardiology.

2. CULPRIT ARTERY–ONLY VERSUS

MULTIVESSEL PCI

(See Section 5.2.2.2 of 2011 PCI guideline and Section 4.1.1of 2013 STEMI guideline for additional recommendations.)

Approximately 50% of patients with STEMI have mul-tivessel disease (25,26). PCI options for patients withSTEMI and multivessel disease include: 1) culprit artery–only primary PCI, with PCI of nonculprit arteries only forspontaneous ischemia or intermediate- or high-risk find-ings on predischarge noninvasive testing; 2) multivesselPCI at the time of primary PCI; or 3) culprit artery–onlyprimary PCI followed by staged PCI of nonculprit arteries.Observational studies, randomized controlled trials(RCTs), and meta-analyses comparing culprit artery–onlyPCI with multivessel PCI have reported conflictingresults (11,12,14–24,27,28), likely because of differing in-clusion criteria, study protocols, timing of multivesselPCI, statistical heterogeneity, and variable endpoints(Data Supplement).

Previous clinical practice guidelines recommendedagainst PCI of nonculprit artery stenoses at the time ofprimary PCI in hemodynamically stable patients withSTEMI (9,10). Planning for routine, staged PCI of non-infarct artery stenoses on the basis of the initial angio-graphic findings was not addressed in these previousguidelines, and noninfarct artery PCI was considered onlyin the limited context of spontaneous ischemia or high-risk findings on predischarge noninvasive testing. Theearlier recommendations were based in part on safetyconcerns, which included increased risks for proceduralcomplications, longer procedural time, contrast nephrop-athy, and stent thrombosis in a prothrombotic and proin-flammatory state (9,10), and in part on the findings frommany observational studies and meta-analyses of trends

2013 Recommendation2015 Focused Update

Recommendation Comment

Class III: Harm Class IIbPCI should not beperformed in anoninfarct artery at thetime of primary PCI inpatients with STEMIwho arehemodynamicallystable (11–13).(Level of Evidence: B)

PCI of a noninfarctartery may beconsidered in selectedpatients with STEMIand multivesseldisease who arehemodynamicallystable, either at thetime of primary PCIor as a planned stagedprocedure (11–24).(Level of Evidence:B-R)

Modifiedrecommendation(changed class from“III: Harm” to “IIb”and expanded timeframe in whichmultivessel PCI couldbe performed).

PCI indicates percutaneous coronary intervention; and STEMI, ST-elevation myocardialinfarction.

toward or statistically significant worse outcomes in thosewho underwent multivessel primary PCI (12–16,21–23).

Four RCTs have since suggested that a strategy ofmultivessel PCI, either at the time of primary PCI or as aplanned, staged procedure, may be beneficial and safe inselected patients with STEMI (17,18,24,27) (Data Supple-ment). In the PRAMI (Preventive Angioplasty in AcuteMyocardial Infarction) trial (n¼465) (24), the compositeprimary outcome of cardiac death, nonfatal myocardialinfarction (MI), or refractory angina occurred in 21 pa-tients (9%) treated with multivessel primary PCI,compared with 53 patients (22%) treated with culpritartery–only PCI (HR: 0.35; 95% CI: 0.21 to 0.58; p<0.001).In the CvLPRIT (Complete Versus Culprit-Lesion OnlyPrimary PCI) trial (18), 296 patients were randomized toculprit artery–only or multivessel PCI during the indexhospitalization (72% underwent multivessel primary PCI).The composite primary outcome of death, reinfarction,heart failure, and ischemia-driven revascularization at12 months occurred in 15 patients (10%) who underwentmultivessel PCI, compared with 31 patients (21%)receiving culprit artery–only PCI (HR: 0.49; 95% CI:0.24 to 0.84; p¼0.009). In the DANAMI 3 PRIMULTI(Third Danish Study of Optimal Acute Treatment ofPatients with ST-segment Elevation Myocardial Infarc-tion) trial (17), the composite primary outcome ofall-cause death, nonfatal MI, or ischemia-driven revas-cularization of nonculprit artery disease occurred in 40of 314 patients (13%) who underwent multivessel stagedPCI guided by angiography and fractional flow reservebefore discharge, versus 68 of 313 patients (22%) treatedwith culprit artery–only PCI (HR: 0.56; 95% CI: 0.38 to0.83; p¼0.004). In the PRAGUE-13 (Primary Angioplastyin Patients Transferred From General Community Hospi-tals to Specialized PTCA Units With or Without Emer-gency Thrombolysis) trial (27), 214 patients with STEMIwere randomized to staged (3 to 40 days after the indexprocedure) revascularization of all $70% diameter ste-nosis noninfarct lesions or culprit-only PCI. Preliminaryresults at 38 months’ mean follow-up showed nobetween-group differences in the composite primaryendpoint of all-cause death, nonfatal MI, and stroke.

On the basis of these findings (17,18,24,27), the priorClass III (Harm) recommendation with regard to multi-vessel primary PCI in hemodynamically stable patientswith STEMI has been upgraded and modified to a Class IIbrecommendation to include consideration of multivesselPCI, either at the time of primary PCI or as a planned,staged procedure. The writing committee emphasizesthat this change should not be interpreted as endorsingthe routine performance of multivessel PCI in all patientswith STEMI and multivessel disease. Rather, whenconsidering the indications for and timing of multivesselPCI, physicians should integrate clinical data, lesion

2011/2013Recommendation

2015 Focused UpdateRecommendations Comments

Class IIa Class IIbManual aspirationthrombectomy isreasonable forpatients undergoingprimary PCI (29–32).(Level of Evidence: B)

The usefulness ofselective andbailout aspirationthrombectomy inpatients undergoingprimary PCI is not wellestablished (33–37).(Level of Evidence:C-LD)

Modifiedrecommendation(Class changedfrom “IIa” to “IIb”for selective andbailout aspirationthrombectomybefore PCI).

Class III: No BenefitRoutine aspirationthrombectomy beforeprimary PCI is notuseful (33–37).(Level of Evidence: A)

New recommendation(“Class III: NoBenefit” added forroutine aspirationthrombectomybefore PCI).

PCI indicates percutaneous coronary intervention; and LD, limited data.



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severity/complexity, and risk of contrast nephropathyto determine the optimal strategy.

The preceding discussion and recommendations applyto the strategy of routine PCI of noninfarct related arteriesin hemodynamically stable patients. Recommendations inthe 2013 STEMI guideline with regard to PCI of a non–infarct-related artery at a time separate from primary PCIin patients who have spontaneous symptoms andmyocardial ischemia or who have intermediate- or high-risk findings on noninvasive testing (Section 6.3 of thatguideline) remain operative.

Although several observational studies (19,20) and anetwork meta-analysis (13) have suggested that multi-vessel staged PCI may be associated with better outcomethan multivessel primary PCI, there are insufficientobservational data and no randomized data at this time toinform a recommendation with regard to the optimaltiming of nonculprit vessel PCI. Additional trial data thatwill help further clarify this issue are awaited. Issuesrelated to the optimal method of evaluating nonculpritlesions (e.g., percent diameter stenosis, fractional flowreserve) are beyond the scope of this focused update.

3. ASPIRATION THROMBECTOMY

(See Section 5.5.2 of the 2011 PCI guideline and Section 4.2 ofthe 2013 STEMI guideline for additional recommendations.)

The 2011 PCI and 2013 STEMI guidelines’ (9,10) Class IIarecommendation for aspiration thrombectomy before pri-mary PCI was based on the results of 2 RCTs (29,31,32) and 1meta-analysis (30) and was driven in large measure by theresults of TAPAS (Thrombus Aspiration During PrimaryPercutaneous Coronary Intervention in Acute MyocardialInfarction Study), a single-center study that randomized1071 patients with STEMI to aspiration thrombectomybefore primary PCI or primary PCI only (29,32). Threemulticenter trials, 2 of which enrolled significantly morepatients than prior aspiration thrombectomy trials, haveprompted reevaluation of this recommendation. In theINFUSE-AMI (Intracoronary Abciximab and AspirationThrombectomy in Patients With Large Anterior MyocardialInfarction) trial (37) of 452 patients with anterior STEMIdue to proximal or mid-left anterior descending occlusion,infarct size was not reduced by aspiration thrombectomybefore primary PCI. The TASTE (Thrombus AspirationDuring ST-Segment Elevation Myocardial Infarction) trial(n¼7,244) incorporated a unique design that allowedrandomization within an existing national registry,resulting in enrollment of a remarkably high proportion ofeligible patients (34,36). No significant 30-day or 1-yeardifferences were found between the group that receivedaspiration thrombectomy before primary PCI and thegroup that received primary PCI only with regard todeath, reinfarction, stent thrombosis, target lesion

revascularization, or a composite of major adverse cardiacevents. The TOTAL (Trial of Routine Aspiration Throm-bectomy With PCI Versus PCI Alone in Patients WithSTEMI) trial randomized 10,732 patients with STEMI toaspiration thrombectomy before primary PCI or primaryPCI only (35). Bailout thrombectomywas performed in 7.1%of the primary PCI–only group, whereas the rate of cross-over from aspiration thrombectomy before primary PCI toprimary PCI only was 4.6%. There were no differencesbetween the 2 treatment groups, either in the primarycomposite endpoint of cardiovascular death, recurrent MI,cardiogenic shock, or New York Heart Association class IVheart failure at 180 days, or in the individual componentsof the primary endpoint, stent thrombosis, or target-vesselrevascularization. There was a small but statistically sig-nificant increase in the rate of stroke in the aspirationthrombectomy group. An updated meta-analysis thatincluded these 3 trials among a total of 17 trials (n¼20,960)found no significant reduction in death, reinfarction, orstent thrombosis with routine aspiration thrombectomy.Aspiration thrombectomy was associated with a small butnonsignificant increase in the risk of stroke (33).

Several previous studies have found that higherthrombus burden in patients with STEMI is independentlyassociated 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 andTOTAL trials did not suggest relative benefit from aspira-tion thrombectomy before primary PCI in patients withhigher thrombus burden or in patients with initial Throm-bolysis inMyocardial Infarction (TIMI) flowgrade 0–1 or leftanterior descending artery/anterior infarction (34,35).

On the basis of the results of these studies, the priorClass IIa recommendation for aspiration thrombectomyhas been changed. Routine aspiration thrombectomybefore primary PCI is now not recommended (Class III: NoBenefit, LOE A). There are insufficient data to assess the


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potential benefit of a strategy of selective or bailoutaspiration thrombectomy (Class IIb, LOE C-LD). “Bailout”aspiration thrombectomy is defined as thrombectomythat was initially unplanned but was later used duringthe procedure because of unsatisfactory initial result orprocedural complication, analogous to the definition of“bailout” glycoprotein IIb/IIIa use.

It should be noted that the preceding recommenda-tions and text apply only to aspiration thrombectomy; noclinical benefit for routine rheolytic thrombectomy hasbeen demonstrated in patients with STEMI undergoingprimary PCI (30,43,44).

PRESIDENTS AND STAFF

American College of Cardiology

Kim A. Williams, Sr, MD, FACC, FAHA, PresidentShalom Jacobovitz, Chief Executive Officer

William J. Oetgen, MD, MBA, FACC, Executive VicePresident, 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 PolicyAbdul R. Abdullah, MD, Associate Science and Medicine

AdvisorAllison Rabinowitz, Project Manager, Science and Clinical

PolicyAmerican Heart Association

Mark A. Creager, MD, FAHA, FACC, PresidentNancy Brown, Chief Executive OfficerRose Marie Robertson, MD, FAHA, Chief Science OfficerGayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice

President, Office of Science OperationsJodyHundley,ProductionManager,ScientificPublications,

Office of Science Operations

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2. Committee on Standards for Developing Trust-worthy Clinical Practice Guidelines, Institute of Medi-cine (US). Clinical Practice Guidelines We Can Trust.Washington, DC: National Academies Press, 2011.

3. Committee on Standards for Systematic Reviewsof Comparative Effectiveness Research, Institute ofMedicine (US). Finding What Works in Health Care:Standards for Systematic Reviews. Washington, DC:National Academies Press, 2011.

4. Anderson JL, Heidenreich PA, Barnett PG, et al.ACC/AHA statement on cost/value methodology inclinical practice guidelines and performance measures:a report of the American College of Cardiology/Amer-ican Heart Association Task Force on PerformanceMeasures and Task Force on Practice Guidelines. J AmColl Cardiol. 2014;63:2304–22.

5. Arnett DK, Goodman RA, Halperin JL, et al. AHA/ACC/HHS strategies to enhance application of clinicalpractice guidelines in patients with cardiovasculardisease and comorbid conditions: from the AmericanHeart Association, American College of Cardiology, andU.S. Department of Health and Human Services. J AmColl Cardiol. 2014;64:1851–6.

6. Jacobs AK, Kushner FG, Ettinger SM, et al. ACCF/AHAclinical practice guideline methodology summit report: areport of the American College of Cardiology Founda-tion/American Heart Association Task Force on PracticeGuidelines. J Am Coll Cardiol. 2013;61:213–65.

7. Jacobs AK, Anderson JL, Halperin JL. The evolutionand future of ACC/AHA clinical practice guidelines: a 30-year journey: a report of the American College of

Cardiology/American Heart Association Task Force onPractice Guidelines. J Am Coll Cardiol. 2014;64:1373–84.

8. Halperin JL, Levine GN, Al-Khatib SM, et al. Furtherevolution of the ACC/AHA clinical practice guidelinerecommendation classification system: a report of theAmerican College of Cardiology/American Heart Asso-ciation Task Force on Clinical Practice Guidelines[published online ahead of print September 23, 2015].J Am Coll Cardiol. 2015, http://dx.doi.org/10.1016/j.jacc.2015.09.001.

9. Levine GN, Bates ER, Blankenship JC, et al. 2011ACCF/AHA/SCAI guideline for percutaneous coronaryintervention: a report of the American College of Car-diology Foundation/American Heart Association TaskForce on Practice Guidelines and the Society for Car-diovascular Angiography and Interventions. J Am CollCardiol. 2011;58:e44–122.

10. O’Gara PT, Kushner FG, Ascheim DD, et al.2013 ACCF/AHA guideline for the management ofST-elevation myocardial infarction: a report of theAmerican College of Cardiology Foundation/AmericanHeart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2013;61:e78–140.

11. Hannan EL, Samadashvili Z, Walford G, et al.Culprit vessel percutaneous coronary interventionversus multivessel and staged percutaneous coronaryintervention for ST-segment elevation myocardialinfarction patients with multivessel disease. J Am CollCardiol Intv. 2010;3:22–31.

12. Toma M, Buller CE, Westerhout CM, et al. Non-culprit coronary artery percutaneous coronary inter-vention during acute ST-segment elevation myocardialinfarction: insights from the APEX-AMI trial. Eur HeartJ. 2010;31:1701–7.

13. Vlaar PJ, Mahmoud KD, Holmes DR Jr., et al. Culpritvessel only versus multivessel and staged percuta-neous coronary intervention for multivessel diseasein patients presenting with ST-segment elevationmyocardial infarction: a pairwise and network meta-analysis. J Am Coll Cardiol. 2011;58:692–703.

14. Cavender MA, Milford-Beland S, Roe MT, et al.Prevalence, predictors, and in-hospital outcomes ofnon-infarct artery intervention during primary percuta-neous coronary intervention for ST-segment elevationmyocardial infarction (from the National CardiovascularData Registry). Am J Cardiol. 2009;104:507–13.

15. Corpus RA, House JA, Marso SP, et al. Multivesselpercutaneous coronary intervention in patients withmultivessel disease and acute myocardial infarction.Am Heart J. 2004;148:493–500.

16. Dziewierz A, Siudak Z, Rakowski T, et al. Impact ofmultivessel coronary artery disease and noninfarct-related artery revascularization on outcome ofpatients with ST-elevation myocardial infarctiontransferred for primary percutaneous coronary inter-vention (from the EUROTRANSFER Registry). Am JCardiol. 2010;106:342–7.

17. Engstrøm T, Kelbæk H, Helqvist S, et al. Completerevascularisation versus treatment of the culpritlesion only in patients with ST-segment elevationmyocardial infarction and multivessel disease (DANAMI3-PRIMULTI): an open-label, randomised controlledtrial. Lancet. 2015;386:665–71.

18. Gershlick AH, Khan JN, Kelly DJ, et al. Randomizedtrial of complete versus lesion-only revascularization inpatients undergoing primary percutaneous coronaryintervention for STEMI and multivessel Disease: theCvLPRIT trial. J Am Coll Cardiol. 2015;65:963–72.

19. Kornowski R, Mehran R, Dangas G, et al. Prognosticimpact of staged versus “one-time” multivesselpercutaneous intervention in acute myocardial infarc-tion: analysis from the HORIZONS-AMI (harmonizingoutcomes with revascularization and stents in acutemyocardial infarction) trial. J Am Coll Cardiol. 2011;58:704–11.

20. Manari A, Varani E, Guastaroba P, et al. Long-termoutcome in patients with ST segment elevationmyocardial infarction and multivessel disease treatedwith culprit-only, immediate, or staged multivesselpercutaneous revascularization strategies: insights

http://assets.cardiosource.com/Methodology_Manual_for_ACC_AHA_Writing_Committees.pdf



http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/documents/downloadable/ucm_319826.pdf



http://refhub.elsevier.com/S0735-1097(15)06797-2/sref2











































































































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from the REAL registry. Catheter Cardiovasc Interv.2014;84:912–22.

21. Politi L, Sgura F, Rossi R, et al. A randomised trialof target-vessel versus multi-vessel revascularisationin ST-elevation myocardial infarction: major adversecardiac events during long-term follow-up. Heart.2010;96:662–7.

22. Roe MT, Cura FA, Joski PS, et al. Initial experiencewith multivessel percutaneous coronary interventionduring mechanical reperfusion for acute myocardialinfarction. Am J Cardiol. 2001;88:170–3, A6.

23. Varani E, Balducelli M, Aquilina M, et al. Singleor multivessel percutaneous coronary intervention inST-elevation myocardial infarction patients. CatheterCardiovasc Interv. 2008;72:927–33.

24. Wald DS, Morris JK, Wald NJ, et al. Randomizedtrial of preventive angioplasty in myocardial infarction.N Engl J Med. 2013;369:1115–23.

25. Sorajja P, Gersh BJ, Cox DA, et al. Impact of mul-tivessel disease on reperfusion success and clinicaloutcomes in patients undergoing primary percutaneouscoronary intervention for acute myocardial infarction.Eur Heart J. 2007;28:1709–16.

26. Park D-W, Clare RM, Schulte PJ, et al. Extent, loca-tion, and clinical significance of non-infarct-related cor-onary artery disease among patients with ST-elevationmyocardial infarction. JAMA. 2014;312:2019–27.

27. HlinomazO.Multivessel coronary disease diagnosedat the time of primary PCI for STEMI: complete revas-cularization versus conservative strategy. PRAGUE13 trial. Available at: http://sbhci.org.br/wp-content/uploads/2015/05/PRAGUE-13-Trial.pdf. AccessedSeptember 10, 2015.

28. Vlaar PJ, Mahmoud KD, Holmes DR Jr., et al. Culpritvessel only versus multivessel and staged percutaneouscoronary intervention formultivessel disease in patientspresenting with ST-segment elevation myocardialinfarction: a pairwise and network meta-analysis. J AmColl Cardiol. 2011;58:692–703.

29. Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiacdeath and reinfarction after 1 year in the ThrombusAspiration during Percutaneous coronary interventionin Acute myocardial infarction Study (TAPAS): a 1-yearfollow-up study. Lancet. 2008;371:1915–20.

30. Bavry AA, Kumbhani DJ, Bhatt DL. Roleof adjunctive thrombectomy and embolic protectiondevices in acute myocardial infarction: a comprehen-sive meta-analysis of randomized trials. Eur Heart J.2008;29:2989–3001.

31. Sardella G, Mancone M, Bucciarelli-Ducci C, et al.Thrombus aspiration during primary percutaneous cor-onary intervention improvesmyocardial reperfusion andreduces infarct size: the EXPIRA (thrombectomy withexport catheter in infarct-related artery during primarypercutaneous coronary intervention) prospective, ran-domized trial. J Am Coll Cardiol. 2009;53:309–15.

32. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombusaspiration during primary percutaneous coronary inter-vention. N Engl J Med. 2008;358:557–67.

33. Elgendy IY, Huo T, Bhatt DL, et al. Is aspirationthrombectomy beneficial in patients undergoing pri-mary percutaneous coronary intervention? Meta-analysis of randomized trials. Circ Cardiovasc Interv.2015;8:e002258.

34. Fröbert O, Lagerqvist B, Olivecrona GK, et al.Thrombus aspiration during ST-segment elevationmyocardial infarction. N Engl J Med. 2013;369:1587–97.

35. Jolly SS, Cairns JA, Yusuf S, et al. Randomized trialof primary PCI with or without routine manual throm-bectomy. N Engl J Med. 2015;372:1389–98.

36. Lagerqvist B, Fröbert O, Olivecrona GK, et al.Outcomes 1 year after thrombus aspiration formyocardial infarction. N Engl J Med. 2014;371:1111–20.

37. Stone GW, Maehara A, Witzenbichler B, et al.Intracoronary abciximab and aspiration thrombectomyin patients with large anterior myocardial infarction:the INFUSE-AMI randomized trial. JAMA. 2012;307:1817–26.

38. Napodano M, Dariol G, Al Mamary AH, et al.Thrombus burden and myocardial damage duringprimary percutaneous coronary intervention. Am JCardiol. 2014;113:1449–56.

39. Sianos G, Papafaklis MI, Daemen J, et al. Angio-graphic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardialinfarction: the importance of thrombus burden. J AmColl Cardiol. 2007;50:573–83.

40. Yip HK, Chen M-C, Chang H-W, et al. Angiographicmorphologic features of infarct-related arteries andtimely reperfusion in acute myocardial infarction:predictors of slow-flow and no-reflow phenomenon.Chest. 2002;122:1322–32.

41. Brener SJ, Dambrink J-H, Maehara A, et al. Benefitsof optimising coronary flow before stenting in primarypercutaneous coronary intervention for ST-elevationmyocardial infarction: insights from INFUSE-AMI.EuroIntervention. 2014;9:1195–201.

42. Costa RA, Abizaid A, Lotan C, et al. Impact ofthrombus burden on outcomes after standard versusmesh-covered stents in acute myocardial infarction(from the MGuard for acute ST elevation reperfusiontrial). Am J Cardiol. 2015;115:161–6.

43. Ali A, Cox D, Dib N, et al. Rheolytic thrombectomywith percutaneous coronary intervention for infarctsize reduction in acute myocardial infarction: 30-dayresults from a multicenter randomized study. J Am CollCardiol. 2006;48:244–52.

44. Migliorini A, Stabile A, Rodriguez AE, et al. Com-parison of AngioJet rheolytic thrombectomy beforedirect infarct artery stenting with direct stentingalone in patients with acute myocardial infarction.The JETSTENT trial. J Am Coll Cardiol. 2010;56:1298–306.

KEY WORDS ACC/AHA Clinical PracticeGuideline, culprit vessel, focused update,multivessel, myocardial infarction, primary PCI,thrombectomy




























http://sbhci.org.br/wp-content/uploads/2015/05/PRAGUE-13-Trial.pdf

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CommitteeMember Employer/Title Consultant

SpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational, orOther Financial

BenefitExpertWitness

VotingRecusals

by Section*

Glenn N. Levine,Chair

Baylor College of Medicine—Professor of Medicine; Director,

Cardiac Care Unit

None None None None None None None

Eric R. Bates,Vice Chair

University of Michigan—Professor of Medicine

� Merck� Sanofi-aventis

None None None None None 2 and 3

James C.Blankenship,Vice Chair

Geisinger Medical Center—Director of Cardiology andCardiac Catheterization

Laboratories

None None None � AbbottVascular†

� Abiomed†� Boston

Scientific†� Volcano†

None None 2 and 3

Steven R. Bailey University of Texas MedicalCenter—Professor of

Medicine and Radiology


John A. Bittl Munroe Heart—Interventional Cardiologist


Bojan Cercek Cedars-Sinai Medical Center—Director, Coronary Care Unit


Charles E.Chambers

Penn State Milton S. HersheyMedical Center—Professor of

Medicine and Radiology


Stephen G. Ellis Cleveland Clinic Foundation—Section Head, Invasive andInterventional Cardiology

� Abbott� Boston Scientific� Medtronic


Robert A. Guyton Emory Clinic, Inc.—Professorand Chief, Division ofCardiothoracic Surgery

� Medtronic‡ None None None None None 2 and 3

Steven M.Hollenberg

Cooper Medical School ofRowan University—Professor

of Medicine


Umesh N. Khot Cleveland Clinic—Vice Chairman,Department of Cardiovascular

Medicine

� AstraZeneca None None None None None None

Richard A. Lange Texas Tech UniversityHealth Sciences Center El

Paso—President


Laura Mauri Brigham & Women’sHospital—Associate Professorof Medicine, Harvard Medical

School

� Medtronic� St. Jude Medical

None None None � Abbott‡� Boston

Scientific‡� Bristol-Myers

Squibb‡� Cordis‡� Medtronic

Cardiovascular‡� Sanofi-aventis‡

None 2 and 3

Roxana Mehran Columbia University MedicalCenter—Associate Professorof Medicine; Director, DataCoordinating Analysis Center

� Abbott Vascular� Boston Scientific� Janssen (John-

son & Johnson)‡� Merck� Sanofi-aventis‡

None None � BMS/Sanofi-aventis‡

� Regado� STENTYS†

None None 2 and 3

Issam D. Moussa University of Central FloridaCollege of Medicine—Professor

of Medicine; First CoastCardiovascular Institute—Chief

Medical Officer


Continued on the next page

APPENDIX 1. AUTHOR RELATIONSHIPSWITH INDUSTRY AND OTHER ENTITIES (RELEVANT)—2015 ACC/AHA/SCAI

FOCUSEDUPDATEONPRIMARYPERCUTANEOUSCORONARY INTERVENTIONFORPATIENTSWITH ST-ELEVATION

MYOCARDIAL INFARCTION (PERCUTANEOUS CORONARY INTERVENTIONWRITING COMMITTEE) (NOVEMBER

2014)


1243

APPENDIX 1. CONTINUED

CommitteeMember Employer/Title Consultant

SpeakersBureau


PersonalResearch



VotingRecusals

by Section*

DebabrataMukherjee

Texas Tech University—Chief,Cardiovascular Medicine


Henry H. Ting New York–Presbyterian Hospital,The University Hospital of

Columbia and Cornell—SeniorVice President and Chief

Quality Officer


This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships werereviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarilyreflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the votingstock or share of the business entity, or ownership of $$5,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% ofthe person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table aremodest unless otherwise noted.According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or

issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competingdrug or device addressed in the document; or c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss asa result of the issues/content addressed in the document.*Writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply.†No financial benefit.‡Significant relationship.

ACC indicates American College of Cardiology; AHA, American Heart Association; and SCAI, Society for Cardiovascular Angiography and Interventions.



1244

CommitteeMember Employment Consultant

SpeakersBureau


PersonalResearch



VotingRecusals

by Section*

Patrick T. O’Gara,Chair

Harvard Medical School—Professor of Medicine


Frederick G.Kushner,Vice Chair

Tulane University School ofMedicine—Clinical Professorof Medicine; Heart Clinic of

Louisiana—MedicalDirector


Deborah D.Ascheim†

Mount Sinai School ofMedicine—Associate Professor;

InCHOIR—Clinical Directorof Research


Ralph G. Brindis UCSF Philip R. Lee Institute forHealth Policy Studies—Clinical

Professor of Medicine


Donald E. Casey,Jr.

Thomas Jefferson College ofPopulation Health—AdjunctFaculty; Alvarez & MarsalIPO4Health—Principal

and Founder


Mina K. Chung Cleveland Clinic Foundation—Professor of Medicine

� BostonScientific§

� Medtronic§� St. Jude

Medical§

None None � BiosenseWebster§

� Boston Scientific§� Medtronic§� St. Jude Medical‡

None None 2 and 3

James A. deLemos

UT Southwestern Medical Center—Professor of Medicine

� AbbottDiagnostics

� Novo Nordisc� St. Jude

Medical

None None � AbbottDiagnostics‡

None None 2 and 3

Deborah B.Diercks

UT Southwestern Medical Center—Audre and Bernard RapoportDistinguished Chair in ClinicalCare and Research; Department

of Emergency Medicine—Professor and Chair


James C. Fang University of Utah—CardiovascularDivision

� BostonScientific


Barry A. Franklin William Beaumont Hospital—Director, Cardiac Rehabilitation

and Exercise Laboratories


Christopher B.Granger

Duke Clinical Research Institute—Director, Cardiac Care Unit;

Professor of Medicine

None None None � MedtronicFoundation‡

� Merck‡

None None 2 and 3

Harlan M.Krumholz

Yale University School ofMedicine—Professor of

Epidemiology andPublic Health

None None None � Johnson &Johnson‡

� Medtronic‡

None None 2 and 3

Jane A.Linderbaum

Mayo Clinic—Assistant Professorof Medicine


David A. Morrow Harvard Medical School—Professor of Medicine

� Abbott� Merck

None None � Abbott‡� GlaxoSmithKline‡� Johnson &

Johnson‡� Merck‡

None None 2 and 3

L. Kristin Newby Duke University Medical Center,Division of Cardiology—Professor

of Medicine

� Philips None None � Merck‡ None None 2 and 3


APPENDIX 2. AUTHOR RELATIONSHIPSWITH INDUSTRY ANDOTHER ENTITIES (RELEVANT)—2015 ACC/AHA/SCAI

FOCUSEDUPDATEONPRIMARYPERCUTANEOUSCORONARY INTERVENTIONFORPATIENTSWITH ST-ELEVATION

MYOCARDIAL INFARCTION (ST-ELEVATION MYOCARDIAL INFARCTION WRITING COMMITTEE) (FEBRUARY 2014)


1245


CommitteeMember Employment Consultant

SpeakersBureau


PersonalResearch



VotingRecusals

by Section*

Joseph P. Ornato Department of EmergencyMedicine Virginia Commonwealth

University—Professorand Chairman


Narith Ou Mayo Clinic—PharmacotherapyCoordinator, Cardiology


Martha J.Radford

NYU Langone Medical Center—Chief Quality Officer; NYU

School of Medicine—Professor of Medicine

(Cardiology)


Jacqueline E.Tamis-Holland

Mount Sinai Saint Luke’s Hospitaland The Icahn School of

Medicine—ProgramDirector, Interventional

Cardiology Fellowship Program


Carl L. Tommaso Skokie Hospital—Director ofCatheterization Laboratory;

NorthShore UniversityHealthSystems—Partner


Cynthia M. Tracy George Washington UniversityMedical Center—Associate

Director, Division of Cardiology


Y. Joseph Woo Stanford University—Professorand Chair, Cardiothoracic Surgery


David X. Zhao Wake Forest Baptist Health—Professor of Medicine, Heart

and Vascular Center ofExcellence Director

None None None � St. Jude Medical§� Medtronic§

None None 2 and 3

This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships werereviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarilyreflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the votingstock or share of the business entity, or ownership of $$5,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% ofthe person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table aremodest unless otherwise noted.According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or

issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competingdrug or device addressed in the document; or c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss asa result of the issues/content addressed in the document.*Writing group members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply.†Dr. Deborah D. Ascheim accepted a position at Capricor Therapeutics in August 2015, after the writing effort was completed. According to policy, she recused herself from the finalvoting process.‡Significant relationship.§No financial benefit.

ACC indicates American College of Cardiology; AHA, American Heart Association; NYU, New York University; UCSF, University of California San Francisco; and UT, University of Texas.



1246

Reviewer Representation Employment ConsultantSpeakersBureau


PersonalResearch



Elliott M. Antman Official Reviewer—AHA Harvard Medical School—Professor of Medicine,

Associate Dean for Clinicaland Translational Research

None None None None None None

Deepak L. Bhatt Official Reviewer—AHA Harvard Medical School—Professor; InterventionalCardiovascular Programs—

Executive Director

None None None � Bristol-Myers Squibb*� Ischemix*� Medtronic*� St. Jude Medical

� RegadoBiosciences†

None

Christopher P. Cannon Official Reviewer—AHA Harvard Medical School—Professor of Medicine;Brigham and Women’s

Hospital—Senior Investigator,TIMI Study Group,

Cardiovascular Division

� Bristol-MyersSquibb

� Merck� Regeneron/

Sanofi-aventis*

None None � Merck* None None

Joaquin E. Cigarroa Official Reviewer—ACC/AHA Task Forceon Clinical Practice

Guidelines

Oregon Health & ScienceUniversity—Clinical Professor

of Medicine


George Dangas Official Reviewer—ACCBoard of Trustees

Icahn School of Medicine—Professor of Cardiology andVascular Surgery; Mount Sinai

Medical Center—Director,Cardiovascular Innovation

� Abbott� Biosensors� Boston Scientific� Johnson & Johnson*� Merck� Osprey Medical*� Regado Biosciences

None None None � Abbott� Medtronic� Osprey

None

Charles J. Davidson Official Reviewer—SCAI Northwestern UniversityFeinberg School of Medicine—

Professor of Medicine,Director of CardiacCatheterization Lab

None None None � Baxter International† None None

Kirk N. Garratt Official Reviewer—SCAI Hofstra University MedicalSchool—Associate Chair ofQuality and Research;Professor of Medicine

� Abbott� Boston Scientific� The Medicines

Company� Daiichi-Sankyo/

Eli Lilly� AstraZeneca

None � LifeCuff Technologies� Global Delivery

Systems

None � BostonScientific

None

Steven L. Goldberg Official Reviewer—SCAI University of WashingtonMedical Center—Cath

Lab Director

� Terumo† None None None None None


APPENDIX 3. REVIEWER RELATIONSHIPSWITH INDUSTRY AND OTHER ENTITIES (RELEVANT)—2015 ACC/AHA/SCAI FOCUSED UPDATE ON PRIMARY

PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTSWITH ST-ELEVATION MYOCARDIAL INFARCTION (COMBINED PEER REVIEWERS FROM 2011

PCI AND 2013 STEMI GUIDELINES)

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PersonalResearch



G.B. John Mancini Official Reviewer—ACCBoard of Governors

Vancouver Hospital ResearchPavilion—Professor

of Medicine

� Merck� Sanofi-aventis/

Regeneron

None None None None None

Jonathan M. Tobis Official Reviewer—SCAI University of California LosAngeles—Professor of

Medicine and Cardiology

� St. Jude Medical None None None None None

Jeffrey L. Anderson Content Reviewer—ACC/AHA Task Force on

Clinical PracticeGuidelines

Intermountain MedicalCenter—Associate Chief

of Cardiology


Thomas M. Bashore Content Reviewer Duke University—Professorof Medicine


James A. Burke Content Reviewer—ACCInterventional Scientific

Council

Lehigh Valley HeartSpecialists—Associate Chief,

Division of Cardiology


Jeffrey J. Cavendish Content Reviewer—ACCPrevention of

Cardiovascular DiseaseCommittee

Kaiser PermanenteCardiology—Interventional

Cardiologist

None None None None � Abbott None

Gregory J. Dehmer Content Reviewer—ACCAppropriate Use Criteria

Texas A&M College ofMedicine—Professor ofMedicine; Scott & White

Healthcare


John S. Douglas, Jr. Content Reviewer Emory University Hospital—Professor of Medicine

None None None � Abbott� Medtronic

None None

John P. Erwin III Content Reviewer—ACC/AHA Task Force onPerformance Measures

Texas A&M College ofMedicine—Associate

Professor; Scott & WhiteHealthcare—Vice Chair of the

Department of Medicine


T. Bruce Ferguson Content Reviewer—ACCSurgeons’ Scientific

Council

East Carolina Institute BrodySchool of Medicine—Professorof Surgery and Physiology


Anthony Gershlick Content Reviewer University Hospitals ofLeicester, Department of

Cardiology

� Abbott� Boston Scientific� Cordis� Medtronic

� Abbott† None None None None

Jonathan L. Halperin Content Reviewer—ACC/AHA Task Force on

Clinical PracticeGuidelines

Mt. Sinai Medical—Professorof Medicine

� Bayer Healthcare� Boston Scientific� Johnson & Johnson� Medtronic

None None None None None



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PersonalResearch



Howard C. Herrmann Content Reviewer University of PennsylvaniaPerelman School of

Medicine—Professor ofMedicine, Director of

Interventional CardiologyProgram

� Seimens Medical� St. Jude Medical

None None � Abbott*� Medtronic� Siemens Medical*� St. Jude Medical

None None

Morton J. Kern Content Reviewer University of CaliforniaIrvine—Professor of Medicine,

Associate Chief of theDivision of Cardiology

� Acist Medical� Merit Medical*

� St. Jude Medical* None None None None

Fred M. Kosumoto Content Reviewer Mayo Clinic—Director, Pacingand Electrophysiology Service


David J. Maron Content Reviewer Stanford University School ofMedicine—Professor of

Medicine and EmergencyMedicine


Douglass A. Morrison Content Reviewer University of Arizona—Professor of Medicine;

Southern Arizona VA HealthCare System—Cardiac

Catheterization Laboratories,Director


Manesh R. Patel Content Reviewer—ACCAppropriate Use Criteria

Duke University MedicalCenter—Associate Professor

of Medicine

� Bayer Healthcare*� Janssen

Pharmaceuticals*

None None � Johnson & Johnson* None None

M. Eugene Sherman Content Reviewer—ACCBoard of Governors

Aurora Denver Cardiology None None None None � Bristol-MyersSquibb*

� Hospira*

None

Daniel I. Simon Content Reviewer University Hospitals CaseMedical Center—Professorof Cardiovascular Research

� Cordis/Johnson &Johnson*

� JanssenPharmaceuticals/Johnson & Johnson

� Medtronic Vascular� Merck

� Abbott None None None None

Richard W. Snyder Content Reviewer—ACCBoard of Governors

HeartPlace None None None None None None

William A. Tansey III Content Reviewer Summit Medical Group—Cardiologist


David D. Waters Content Reviewer San Francisco GeneralHospital—Chief, Division

of Cardiology

None None None None � Merck None


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Institutional,Organizational, or

Patrick L. Whitlow Content Reviewer Cleveland Clinic Foundation—Director, Interventional

Cardiology

None None None

David O. Williams Content Reviewer Harvard Medical School—Professor of Medicine;Brigham and Women’s

Hospital

None None None

Clyde W. Yancy Content Reviewer—ACC/AHA Task Force on

Practice Guidelines

Northwestern UniversityFeinberg School of Medicine—Vice Dean for Diversity andInclusion, Chief of Medicine-

Cardiology, Professor

None None None

Yerem Yeghiazarians Content Reviewer University of California SanFrancisco—Associate

Professor

None None None

This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Itpublication. A person is deemed to have a significant interest in a business if the interest represents ownership of$5% of the voting stock or share of the business entity, or ownershipreceived by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant unbenefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each categorAccording to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or i

the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a membprofessional, or other personal gain or loss as a result of the issues/content addressed in the document.*Significant relationship.†No financial benefit.

ACC indicates American College of Cardiology; AHA, American Heart Association; SCAI, Society for Cardiovascular Angiography and Interventions; STEMI, ST-elevation myocardial infIn Myocardial Infarction; and VA, Veterans Affairs.


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PersonalResearch

Other FinancialBenefit

ExpertWitness

� Abbott � Medtronic*

None None None

None None None

None None None

does not necessarily reflect relationships with industry at the time ofof$$5,000 of the fair market value of the business entity; or if fundsder the preceding definition. Relationships that exist with no financialy of review.ssue addressed in the document; or b) the company/entity (with whomer of the person’s household has a reasonable potential for financial,

arction; PCI, percutaneous coronary interventions; TIMI, Thrombolysis

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/SCAIFocused

Update

onPrim

aryPCI

MARCH

15,2016:12

35–50

2015 acc/aha/scai focused update on primary ...2015 acc/aha/scai focused update on primary pci march...

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