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Hillis et al 2011 ACCF/AHA CABG Guideline e731

Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

 

 

 

 

 

 

Institutional,

 

Voting

 

 

 

 

Ownership/

 

Organizational, or

 

Recusals by

Committee

 

 

 

Partnership/

Personal

Other Financial

 

Section

Member

Employer/Title

Consultant

Speaker’s Bureau

Principal

Research

Benefit

Expert Witness

Numbers*

 

 

 

 

 

 

 

 

 

L. David

University of Texas Health

None

None

None

None

None

None

None

Hillis (Chair)

Science Center at San

 

 

 

 

 

 

 

 

Antonio—Professor and

 

 

 

 

 

 

 

 

Chair of the Department of

 

 

 

 

 

 

 

 

Medicine

 

 

 

 

 

 

 

Peter K.

Duke University Medical

Eli Lilly

None

None

None

None

None

2.2.3

Smith (Vice

Center: Private Diagnostic

Baxter BioSurgery

 

 

 

 

 

4.1

Chair)

Clinic—Professor of

 

 

 

 

 

 

4.2

 

Surgery; Chief of Thoracic

 

 

 

 

 

 

5.2.6

 

Surgery

 

 

 

 

 

 

 

Jeffrey L.

Intermountain Medical

BMS/sanofi-aventis

None

None

AstraZeneca

None

None

2.1.6

Anderson

Center—Associate Chief of

 

 

 

Gilead Pharma

 

 

2.2.3

 

Cardiology

 

 

 

Toshiba†

 

 

4.1

 

 

 

 

 

 

 

 

4.2

 

 

 

 

 

 

 

 

4.3

 

 

 

 

 

 

 

 

5.2.6

John A. Bittl

Ocala Heart Institute

None

None

None

None

None

None

None

 

Munroe Regional Medical

 

 

 

 

 

 

 

 

Center—Interventional

 

 

 

 

 

 

 

 

Cardiologist

 

 

 

 

 

 

 

Charles R.

University of Pennsylvania

Baxter BioSurgery†

Bayer

None

None

None

Plaintiff, alleged mitral

2.2.3

Bridges

Medical Center—Chief of

Zymogenetics

Pharmaceuticals

 

 

 

valve dysfunction, 2009

4.1

 

Cardiothoracic Surgery

 

 

 

 

 

Defendant, retinal artery

4.2

 

 

 

 

 

 

 

occlusion (stroke) after

5.2.6

 

 

 

 

 

 

 

CABG, 2009

 

 

 

 

 

 

 

 

Defendant, timely

 

 

 

 

 

 

 

 

insertion of IABP after

 

 

 

 

 

 

 

 

CABG, 2009

 

 

 

 

 

 

 

 

Defendant, timely

 

 

 

 

 

 

 

 

transport after acute

 

 

 

 

 

 

 

 

aortic dissection, 2009

 

 

 

 

 

 

 

 

Plaintiff, unexpected

 

 

 

 

 

 

 

 

intra-abdominal

 

 

 

 

 

 

 

 

hemorrhage and death

 

 

 

 

 

 

 

 

after AVR, 2009

 

John G.

Vanderbilt University

None

None

None

None

None

None

None

Byrne

Medical Center: Division of

 

 

 

 

 

 

 

 

Cardiac

 

 

 

 

 

 

 

 

Surgery—Chairman of

 

 

 

 

 

 

 

 

Cardiac Surgery

 

 

 

 

 

 

 

Joaquin E.

Oregon Health and

None

None

None

None

None

None

None

Cigarroa

Science

 

 

 

 

 

 

 

 

University—Associate

 

 

 

 

 

 

 

 

Professor of Medicine

 

 

 

 

 

 

 

Verdi J.

John Hopkins Hospital,

None

None

None

None

None

None

None

DiSesa

Division of Cardiac

 

 

 

 

 

 

 

 

Surgery—Clinical

 

 

 

 

 

 

 

 

Associate

 

 

 

 

 

 

 

Loren F.

Cardiac, Vascular and

None

None

None

None

None

None

None

Hiratzka

Thoracic Surgeons,

 

 

 

 

 

 

 

 

Inc.—Medical Director of

 

 

 

 

 

 

 

 

Cardiac Surgery

 

 

 

 

 

 

 

Adolph M.

Massachusetts General

None

None

None

None

None

None

None

Hutter, Jr.

Hospital—Professor of

 

 

 

 

 

 

 

 

Medicine

 

 

 

 

 

 

 

Michael E.

UT Southwestern Medical

Quest Medical†

None

None

None

None

None

2.1.8

Jessen

Center—Professor of

 

 

 

 

 

 

 

 

Cardiothoracic Surgery

 

 

 

 

 

 

 

Ellen C.

University of

None

None

None

None

None

None

None

Keeley

Virginia—Associate

 

 

 

 

 

 

 

 

Professor of Internal

 

 

 

 

 

 

 

 

Medicine

 

 

 

 

 

 

 

Stephen J.

University of

None

None

None

None

None

Defendant, mitral valve

None

Lahey

Connecticut—Professor

 

 

 

 

 

replacement, 2009

 

 

and Chief of

 

 

 

 

 

 

 

 

Cardiothoracic Surgery

 

 

 

 

 

 

 

(Continued)

e732

Circulation

December 6, 2011

 

 

 

 

 

 

Appendix 1.

Continued

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Institutional,

 

Voting

 

 

 

 

 

Ownership/

 

Organizational, or

 

Recusals by

Committee

 

 

 

 

Partnership/

Personal

Other Financial

 

Section

Member

 

Employer/Title

Consultant

Speaker’s Bureau

Principal

Research

Benefit

Expert Witness

Numbers*

 

 

 

 

 

 

 

 

 

Richard A.

University of Texas Health

None

None

None

None

None

None

None

Lange

 

Science Center at San

 

 

 

 

 

 

 

 

 

Antonio—Professor of

 

 

 

 

 

 

 

 

 

Medicine

 

 

 

 

 

 

 

Martin J.

University of California San

None

None

None

None

None

None

None

London

Francisco, Veterans Affairs

 

 

 

 

 

 

 

 

Medical Center—Professor

 

 

 

 

 

 

 

 

 

of Clinical Anesthesia

 

 

 

 

 

 

 

Michael J.

The Heart Hospital Baylor

Cordis

None

None

None

None

None

2.1.3

Mack

 

Plano—Cardiovascular

Marquett

 

 

 

 

 

2.2.1

 

Surgery, Medical Director

Medtronic

 

 

 

 

 

5.2.1.1

 

 

 

Edwards Lifesciences†

 

 

 

 

 

5.2.1.2

Manesh R.

 

Duke University Medical

None

None

None

None

None

None

None

Patel

 

Center—Associate

 

 

 

 

 

 

 

 

 

Professor of Medicine

 

 

 

 

 

 

 

John D.

 

Emory University/Emory

Marquett

None

None

Marquett‡

None

None

2.1.3

Puskas

 

Healthcare—Chief of

Medtronic

 

 

Medtronic‡

 

 

2.2.1

 

 

Cardiac Surgery

 

 

 

 

 

 

2.2.2

Joseph F.

 

Cleveland Clinic

Edwards Lifesciences

None

None

None

None

None

2.2.2

Sabik

Foundation—Professor of

Medtronic

 

 

 

 

 

5.2.1.1

 

 

Surgery

 

 

 

 

 

 

5.2.1.2

Ola Selnes

 

John Hopkins Hospital,

None

None

None

None

None

None

None

 

 

Department of

 

 

 

 

 

 

 

 

 

Neurology—Professor of

 

 

 

 

 

 

 

 

 

Neurology

 

 

 

 

 

 

 

David M.

 

Massachusetts General

None

None

None

None

None

None

None

Shahian

 

Hospital—Professor of

 

 

 

 

 

 

 

 

 

Surgery

 

 

 

 

 

 

 

Jeffrey C.

 

John Hopkins School of

None

None

None

Toshiba‡

None

None

2.1.7

Trost

 

Medicine—Assistant

 

 

 

 

 

 

4.10

 

 

Professor of Medicine

 

 

 

 

 

 

4.10.1

 

 

 

 

 

 

 

 

 

4.10.2

 

 

 

 

 

 

 

 

 

4.10.3

 

 

 

 

 

 

 

 

 

5.2.1.1.1

 

 

 

 

 

 

 

 

 

5.2.1.1.2

Michael D.

 

University of Mississippi

None

None

None

None

None

None

None

Winniford

Medical Center—Professor

 

 

 

 

 

 

 

 

 

of Medicine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect 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 voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the 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 are modest unless otherwise noted.

According to the ACCF/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 competing drug 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 as a result of the issues/content addressed in the document.

*Writing committee 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.

AVR indicates aortic valve replacement; CABG, coronary artery bypass graft surgery; and IABP, intraaortic balloon pump.

Hillis et al 2011 ACCF/AHA CABG Guideline e733

Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant)—2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

 

 

 

 

 

 

Institutional,

 

 

 

 

 

Ownership/

 

Organizational, or

 

 

 

 

 

Partnership/

 

Other Financial

 

Peer Reviewer

Representation

Consultant

Speaker’s Bureau

Principal

Personal Research

Benefit

Expert Witness

 

 

 

 

 

 

 

 

Robert Guyton

Official

None

None

None

Edwards

None

None

 

Reviewer—ACCF/

 

 

 

Lifesciences

 

 

 

AHA Task Force on

 

 

 

 

 

 

 

Practice Guidelines

 

 

 

 

 

 

Jeffrey Jacobs

Official

None

None

None

None

None

None

 

Reviewer—ACCF/

 

 

 

 

 

 

 

AHA Task Force on

 

 

 

 

 

 

 

Data Standards

 

 

 

 

 

 

L. Kristin

Official

AstraZeneca

None

None

Eli Lilly*

None

None

Newby

Reviewer—AHA

 

 

 

GlaxoSmithKline†

 

 

Eric D.

Official

AstraZeneca

None

None

BMS/sanofi-aventis†

None

None

Peterson

Reviewer—ACCF/

 

 

 

Eli Lilly†

 

 

 

AHA Task Force on

 

 

 

 

 

 

 

Performance

 

 

 

 

 

 

 

Measures

 

 

 

 

 

 

Richard J.

Official

Edwards

None

None

None

None

None

Shemin

Reviewer—AHA

Lifesciences

 

 

 

 

 

Hector Ventura

Official

None

Actelion

None

None

None

None

 

Reviewer—ACCF

 

Gilead

 

 

 

 

 

Board of Governors

 

 

 

 

 

 

Thad F. Waites

Official

None

None

None

None

None

None

 

Reviewer—ACCF

 

 

 

 

 

 

 

Board of Trustees

 

 

 

 

 

 

T. Bruce

Organizational

None

None

None

None

None

None

Ferguson, Jr

Reviewer—STS

 

 

 

 

 

 

Stephen E.

Organizational

None

None

None

None

Merck

Defendant, leaking

Fremes

Reviewer—AATS

 

 

 

 

 

thoracic aortic

 

 

 

 

 

 

 

aneurysm, 2009

 

 

 

 

 

 

 

Defendant, aortic

 

 

 

 

 

 

 

dissection, 2009

Colleen G.

Organizational

None

None

None

None

None

None

Koch

Reviewer—SCA

 

 

 

 

 

 

Harold L.

Organizational

None

None

None

None

None

None

Lazar

Reviewer—AATS

 

 

 

 

 

 

Walter H.

Organizational

None

None

None

None

None

None

Merrill

Reviewer—STS

 

 

 

 

 

 

Stanton K.

Organizational

None

Philips Healthcare

None

None

None

Plaintiff, communication

Shernan

Reviewer—SCA

 

 

 

 

 

of echocardiography

 

 

 

 

 

 

 

results, 2010

Joseph S.

Content Reviewer

Bayer

None

None

None

None

None

Alpert

 

Sanofi-aventis

 

 

 

 

 

Robert M.

Content Reviewer

AstraZeneca

None

None

Eli Lilly†

None

None

Califf

 

Daiichi-Sankyo

 

 

Bayer

 

 

 

 

GlaxoSmithKline

 

 

 

 

 

 

 

Medtronic

 

 

 

 

 

 

 

Sanofi-aventis

 

 

 

 

 

Robbin G.

Content Reviewer

None

None

None

None

None

Defendant, death after

Cohen

 

 

 

 

 

 

minimally invasive heart

 

 

 

 

 

 

 

surgery, 2011

 

 

 

 

 

 

 

Defendant, diagnosis of

 

 

 

 

 

 

 

aortic dissection, 2010

 

 

 

 

 

 

 

Plaintiff, renal failure

 

 

 

 

 

 

 

and Aprotinin, 2010

Mark A.

Content

AstraZeneca

None

None

Merck

None

Plaintiff, Fasudil

Creager

Reviewer—ACCF/

Genzyme

 

 

 

 

Development: Asahi

 

AHA Task Force on

Merck

 

 

 

 

Pharma v Actelion,

 

Practice Guidelines

Roche

 

 

 

 

2010

 

 

Vascutek

 

 

 

 

 

 

 

 

 

 

 

 

(Continued)

 

 

 

 

 

 

 

 

e734

Circulation

December 6, 2011

 

 

 

 

Appendix 2.

Continued

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Institutional,

 

 

 

 

 

 

Ownership/

 

Organizational, or

 

 

 

 

 

 

Partnership/

 

Other Financial

 

Peer Reviewer

 

Representation

Consultant

Speaker’s Bureau

Principal

Personal Research

Benefit

Expert Witness

 

 

 

 

 

 

 

 

 

Steven M.

 

Content

None

None

None

Medtronic

None

None

Ettinger

 

Review—ACCF/AHA

 

 

 

 

 

 

 

 

Task Force on

 

 

 

 

 

 

 

 

Practice Guidelines

 

 

 

 

 

 

David P. Faxon

Content Reviewer

Sanofi-aventis

None

None

None

None

Defendant, cath

 

 

 

 

 

 

 

 

vascular access site

 

 

 

 

 

 

 

 

complication, 2009

Kirsten E.

 

Content Reviewer

None

None

None

None

None

None

Fleischmann

 

 

 

 

 

 

 

 

Lee Fleisher

 

Content Reviewer

None

None

None

Pfizer

AstraZeneca†

Defendant, perioperative

 

 

 

 

 

 

 

 

stroke, 2009

Anthony P.

 

Content

None

None

None

None

None

Defendant, Bayer Corp.

Furnary

 

Reviewer—ACCF

 

 

 

 

 

Trasylol litigation,

 

 

Surgeons’ Scientific

 

 

 

 

 

2009 to 2011

 

 

Council

 

 

 

 

 

 

Valentin Fuster

 

Content Reviewer

None

None

None

None

None

None

John W.

 

Content Reviewer

GlaxoSmithKline

None

None

None

None

None

Hirshfeld, Jr

 

 

 

 

 

 

 

 

Judith S.

 

Content

Eli Lilly

None

None

None

None

None

Hochman

 

Reviewer—ACCF/

GlaxoSmithKline

 

 

 

 

 

 

 

AHA Task Force on

 

 

 

 

 

 

 

 

Practice Guidelines

 

 

 

 

 

 

James L.

 

Content Reviewer

Roche

None

None

Roche

None

None

Januzzi, Jr

 

 

 

 

 

 

 

 

Frederick G.

 

Content

None

None

None

None

None

None

Kushner

 

Reviewer—Vice

 

 

 

 

 

 

 

 

Chair, 2012 STEMI

 

 

 

 

 

 

 

 

Guideline Writing

 

 

 

 

 

 

 

 

Committee

 

 

 

 

 

 

Glenn Levine

 

Content

None

None

None

None

None

None

 

 

Review—Chair,

 

 

 

 

 

 

 

 

2011 PCI Guideline

 

 

 

 

 

 

 

 

Writing Committee

 

 

 

 

 

 

Donald Likosky

Content Reviewer

None

None

None

Maquet†

None

None

 

 

 

 

 

 

Medtronic†

 

 

James J.

 

Content

None

None

None

None

None

Defendant, acute aortic

Livesay

 

Reviewer—Southern

 

 

 

 

 

dissection, 2011

 

 

Thoracic Surgical

 

 

 

 

 

Defendant, cardiac

 

 

Association

 

 

 

 

 

mortality review, 2010

 

 

 

 

 

 

 

 

Defendant, heparin

 

 

 

 

 

 

 

 

induced

 

 

 

 

 

 

 

 

thrombocytopenia, 2010

Bruce W. Lytle

 

Content

None

None

None

None

None

None

 

 

Reviewer—2004

 

 

 

 

 

 

 

 

CABG Guideline

 

 

 

 

 

 

 

 

Writing Committee

 

 

 

 

 

 

Robert A.

 

Content

None

None

None

None

None

None

Marlow

 

Reviewer—2004

 

 

 

 

 

 

 

 

CABG Guideline

 

 

 

 

 

 

 

 

Writing Committee

 

 

 

 

 

 

Rick A.

 

Content

None

None

None

None

None

None

Nishimura

 

Reviewer—ACCF

 

 

 

 

 

 

 

 

Board of Trustees

 

 

 

 

 

 

Patrick O’Gara

 

Content

None

None

None

None

None

None

 

 

Reviewer—Chair,

 

 

 

 

 

 

 

 

2012 STEMI

 

 

 

 

 

 

 

 

Guideline Writing

 

 

 

 

 

 

 

 

Committee

 

 

 

 

 

 

(Continued)

 

 

 

 

Hillis et al

2011 ACCF/AHA CABG Guideline

e735

Appendix 2.

Continued

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Institutional,

 

 

 

 

 

 

Ownership/

 

Organizational, or

 

 

 

 

 

 

Partnership/

 

Other Financial

 

 

Peer Reviewer

Representation

Consultant

Speaker’s Bureau

Principal

Personal Research

Benefit

Expert Witness

 

 

 

 

 

 

 

 

 

E. Magnus

Content

AstraZeneca

Boehringer

None

Daiichi-Sankyo

None

None

 

Ohman

Reviewer—ACCF/

Bristol-Myers

Ingelheim

 

Datascope

 

 

 

 

AHA Task Force on

Squibb

Gilead Sciences

 

Eli Lilly

 

 

 

 

Practice Guidelines

Boehringer

 

 

 

 

 

 

 

 

Ingelheim

 

 

 

 

 

 

 

 

Gilead Sciences

 

 

 

 

 

 

 

 

Merck

 

 

 

 

 

 

 

 

Pozen

 

 

 

 

 

 

 

 

Sanofi-aventis

 

 

 

 

 

 

John D.

Content Reviewer

None

None

None

None

None

None

 

Rutherford

 

 

 

 

 

 

 

 

George A.

Content Reviewer

None

None

None

None

None

Defendant, review of

Stouffer

 

 

 

 

 

 

malpractice claim, 2010

Mathew

Content—ACCF

Edwards

None

None

None

None

None

 

Williams

Interventional

Lifesciences

 

 

 

 

 

 

 

Scientific Council

Medtronic

 

 

 

 

 

 

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. It does not necessarily reflect 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 voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received 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 under the preceding definition. Relationships that exist with no financial benefit 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 category of review.

According to the ACCF/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 competing drug 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 as a result of the issues/content addressed in the document.

*No financial benefit. †Significant relationship.

AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; CABG, coronary artery bypass graft surgery; PCI, percutaneous coronary intervention; SCA, Society of Cardiovascular Anesthesiologists; STEMI, ST-elevation myocardial infarction; and STS, Society of Thoracic Surgeons.

Appendix 3. Abbreviation List

ACE angiotensin-converting enzyme

LIMA left internal mammary artery

ACS acute coronary syndrome

LV left ventricular

AF atrial fibrillation

LVEF left ventricular ejection fraction

AKI acute kidney injury

MACE major adverse coronary events

ARB angiotensin-receptor blockers

MI myocardial infarction

BMS bare-metal stent

NSTEMI non-ST-elevation myocardial infarction

CABG coronary artery bypass graft surgery

PAC pulmonary artery catheter

CAD coronary artery disease

PAD peripheral artery disease

CKD chronic kidney disease

PCI percutaneous coronary intervention

CPB cardiopulmonary bypass

RCT randomized controlled trial

DAPT dual antiplatelet therapy

SIHD stable ischemic heart disease

DES drug-eluting stent

SIRS systemic inflammatory response system

EF ejection fraction

STEMI ST-elevation myocardial infarction

GDMT guideline-directed medical therapy

SVG saphenous vein graft

ICU intensive care unit

TEE transesophageal echocardiography

IMA internal mammary artery

TIA transient ischemic attack

LAD left anterior descending

TMR transmyocardial laser revascularization

LDL low-density lipoprotein

UA unstable angina

 

 

Correction

In the article by Hillis et al, “2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” which published ahead of print on November 7, 2011, and appears in the December 6, 2011, issue of the journal (Circulation. 2011;124:e652– e735), a correction was needed.

On page e689, in the second column, under “5.2.2. Mediastinitis/Perioperative Infection: Recommendations,” the second recommendation under Class I read,

2.A second-generation cephalosporin is recommended for prophylaxis in patients without methicillin-resistant Staphylococcus aureus colonization.897–905 (Level of Evidence: A)

It has been changed to read,

2.A firstor second-generation cephalosporin is recommended for prophylaxis in patients without methicillin-resistant Staphylococcus aureus colonization.897–905

(Level of Evidence: A)

This correction has been made to the current online version of the article, which is available at http://circ.ahajournals.org/cgi/reprint/124/23/e652.

DOI: 10.1161/CIR.0b013e318242d5c8

(Circulation. 2011;124:e957.)

© 2011 American Heart Association, Inc.

Circulation is available at http://circ.ahajournals.org

e957

2011 ACCF/AHA Coronary Artery Bypass Graft Surgery Data Supplements

Data Supplement 1. Anesthetic Considerations

Author

Drug

Number of

Number of

RR (95% CI)

P-Value

 

Mortality

RR

P-Value

Number of

RR

P-Value

Sternal

RR

P-Value

 

 

Patients

patients with

 

 

Number of

(95% CI)

 

Patients

(95%

 

Infection in

(95% CI)

 

 

 

 

 

≥1 SAE

 

 

Patients (%)

 

 

with CV

CI)

 

Patients (%)

 

 

 

 

 

 

(%)

 

 

 

 

 

 

events (%)

 

 

 

 

 

Ott et. al.

Standard Care

151

15

(9.9)

 

 

0

(0)

 

 

4 (2.6)

 

 

0 (0)

 

 

2003 (1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Parecoxib/vald

311

59

(19.0)

 

0.015

4

(1.3)

 

0.31

17 (5.4)

 

 

10 (3.2)

 

0.035

 

ecoxib

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nussmeier et

Placebo

560

22

(4.0)

 

 

1

(0.2)

 

 

3 (0.5)

 

 

16 (2.9)

 

 

al. 2005 (2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Placebo+Vald

556

40

(7.4)

1.9 (1.1 to

0.02

3

(0.6)

3.0 (0.3 to

0.31

6 (1.1)

2.0 (0.5

0.31

27 (5.0)

1.7 (0.9 to 3.3)

0.08

 

ecoxib

 

 

 

3.2)

 

 

 

29.3)

 

 

to 8.1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Parecoxib/vald

555

40

(7.4)

1.9 (1.1 to

0.02

4

(0.7)

4.1 (0.5 to

0.18

11 (2.0)

3.7 (1.0

0.03

20 (3.7)

1.3 (0.7 to 2.5)

0.48

 

ecoxib

 

 

 

3.2)

 

 

 

36.4)

 

 

to 13.5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Both COX-2

1,088

1,088 (7.4)

2.9 (0.8 to

0.08

7

(0.6)

3.6 (0.4 to

0.2

17 (1.6)

2.9 (0.8

0.08

47 (4.3)

1.5 (0.8 to 2.7)

0.15

 

Groups

 

 

 

9.9)

 

 

 

29.1)

 

 

to 9.9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CI indicates confidence interval; COX-2; cyclooxygenase-2 inhibitors; CV, cardiovascular; N, number of patients; RR, relative risk; and SAE, serious adverse events.

Data Supplement 2. Preconditioning: Table 1

Author

Study Population

Comparison

Protocol

Primary Outcome

Comments

De Hurt et al. 2009 (3)

Elective CABG, 8 centers

TIVA only n=145; SEVO

Minimum end-tidal volatile

Peak postoperative troponin T release:

Only variable associated with elevated troponin

 

Belgium, 2002 to 2004

n=132; DES n=137

concentration 0.5 MAC starting at least

TIVA 0.30 ng/ml (0.00 to 4.79); SEVO

was use of >2 distal anastomoses; volatile

 

 

 

30 min prior to cross-clamping

0.33 ng/ml (0.02 to 3.68);

assignment associated with shorter LOS; only

 

 

 

continued until at least 10 min after the

DES 0.39 ng/ml (0.08 to 3.74); p=NS

significant predictor of 1 y mortality was

 

 

 

release of the cross-clamp on CPB

between groups

EUROSCORE >2

 

 

 

otherwise anesthesia not controlled

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

Frassdorf et al 2009 (4)

Elective CABG, single center

TIVA only n=10,

10 min prior to CPB onset, SEVO

Peak postoperative tropronin I release:

Translocation of PKC epsilon observed in SEVO

 

 

SEVO group I n=10,

group I received 1.0 MAC SEVO for 5

TIVA only 14±3 ng/ml;

group II from cytosol to nuclear fraction

 

 

SEVO group II n=10

min;

SEVO group I 14±3 ng/ml; SEVO

consistent with preconditioning

 

 

 

SEVO group II received (2 times) 5

group II group 7±2 ng/ml;

 

 

 

 

min of SEVO, with 5 min washout 10

TIVA only and SEVO group I vs.

 

 

 

 

min before CPB.

SEVO group II; p<0.001

 

 

 

 

 

 

 

Flier 2010 (5)

Elective CABG, single center

Group I: n=51; Group P:

Group I: ISO 0.5 to 1.0 MAC with SUF

Peak postoperative troponin I release:

No differences in in-hospital mortality or

 

 

n=49

Group P: PROP 2 to 4 mg/kg/h with

Group I: 2.72 mg/ml (95% CI: 1.78 to

morbidity, 1 y-mortality

 

 

 

SUF throughout surgery

5.85) vs. Group P: 2.64 mg/ml (95%

 

 

 

 

 

CI: 1.67 to 4.83); p=0.11

 

 

 

 

 

 

 

CI, confidence interval; CPB indicates cardiopulmonary bypass; CV, cardiovascular; DES, desflurane; EUROSCORE, European System for Cardiac Operative Risk Evaluation; ISO, isoflurane; LOS, length of stay; MAC, minimum alveolar concentration; NS, non significant; PKC, protein kinase C; PROP, propofol; RCT, randomized controlled trial; RR, relative risk; SEVO, sevoflurane; SUF, sufentanil; and TIVA, total intravenous anesthesia.

Data Supplement 3. Preconditioning: Table 2

Author

Study Population

Study

Proposed

Patients With

%

Patients With

%

ARR

RR

95% CI

P-Value

Comments

 

 

Drug

Mechanism

Event/Total

 

Event/Total

 

 

 

 

 

 

 

 

 

 

Patients for

 

Patients

 

 

 

 

 

 

 

 

 

 

Placebo

 

Treated

 

 

 

 

 

 

Mangano et al.

Subanalysis of 2 y

Acadesin

Purine analog

Death 15/54

Death

Death 3/46

Death 6.5%

Death 0.213

Death

Death

Death 0.013

Subsequent large scale RCT:

2006 (6)

outcome of 100

e

increases local

Periop MI

27.8%

Periop MI

Periop MI

Periop MI

0.765

0.239 to

MI 0.53

RED-CABG (Effect of

 

patients sustaining

 

adenosine

54/1358

Periop MI

46/1337

3.4%

0.005

Periop

0.928

 

Acadesine on Reducing

 

perioperative MI

 

levels, inhibit

 

4.0%

 

 

 

MI 0.135

Periop MI

 

Cardiovascular and

 

in larger RCT

 

mPTP opening

 

 

 

 

 

 

0.273 to

 

Cerebrovascular Adverse

 

(Acadesine Trial

 

 

 

 

 

 

 

 

0.412

 

Events in Coronary Artery

 

1024 conducted in

 

 

 

 

 

 

 

 

 

 

Bypass Graft)

 

2,695 CABG

 

 

 

 

 

 

 

 

 

 

(NCT00872001) with

 

patients at 54

 

 

 

 

 

 

 

 

 

 

planned enrollment of 7,500

 

centers from 1993

 

 

 

 

 

 

 

 

 

 

patients was terminated for

 

to 1994 evaluating

 

 

 

 

 

 

 

 

 

 

futility by sponsor Oct. 2010

 

efficacy in

 

 

 

 

 

 

 

 

 

 

 

 

reduction of

 

 

 

 

 

 

 

 

 

 

 

 

cardiac death, MI

 

 

 

 

 

 

 

 

 

 

 

 

or stroke by POD

 

 

 

 

 

 

 

 

 

 

 

 

4) stopped for

 

 

 

 

 

 

 

 

 

 

 

 

futility.

 

 

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Mentzer et al

5,761 CABG

Cariporid

Inhibitor of

Periop MI

Periop MI

Periop MI

Periop MI

Periop MI

Periop

 

Periop MI

Periop MI 0.003

No difference in mortality

2008

patients at high-

e

sodium

562/2891

19.4%

439/2870

15.3%

0.041

MI 0.213

0.118 to

Cerebrovascular

noted at 6 mo follow-up,

(EXPEDITIO

risk for

 

hydrogen

6 m

Cerebrovasc

Cerebrovascula

Cerebrovasc

Cerebrovascul

Cerebrov

0.298

Events 0.0001

beneficial effects persisted.

N Study) (7)

perioperative

 

exchanger

Cerebrovascul

ular Events

r Events

ular Events

ar Events

ascular

 

Cerebrova

 

 

 

ischemic events at

 

(isoform 1)

ar Events

3.0% Periop

146/2870

5.2%

0.021

Events

 

scular

 

 

 

235 centers in 26

 

limits

86/2839

Death 1.5%

 

Periop

 

0.679

 

Events

 

 

 

countries from

 

intracellular

 

 

 

Death 2.2%

 

 

 

1.181 to

 

 

 

2001 to 2002

 

calcium

 

 

 

 

 

 

 

0.293

 

 

 

(terminated early

 

overload

 

 

 

 

 

 

 

 

 

 

 

due to mortality

 

 

 

 

 

 

 

 

 

 

 

 

 

from increased

 

 

 

 

 

 

 

 

 

 

 

 

 

cerebrovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

events)

 

 

 

 

 

 

 

 

 

 

 

 

MEND-

3,023 intermediate

MC-1

Purinergic

Periop CV

9.00%

Periop CV

9.30%

-0.003

-0.036

"-0.299 to

0.809

 

CABG II

to high risk CABG

 

receptor

death or MI

 

death or MI

 

 

 

 

0.174"

 

 

Investigators

patients at 130

 

antagonist

133/1,486

 

140/1,510

 

 

 

 

 

 

 

2008 (8)

sites in 3 countries

 

preventing

 

 

 

 

 

 

 

 

 

 

 

from 2006 to 2007

 

cellular calcium

 

 

 

 

 

 

 

 

 

 

 

 

 

overload

 

 

 

 

 

 

 

 

 

 

Smith et al.

Discrete and

Pexelizu

Monoclonal

PRIMO II 30

PRIMO II

PRIMO II 30 d

PRIMO II

PRIMO II 30

PRIMO

 

PRIMO II

PRIMO II 30 d

Combined analysis of

2010

combined analyses

mab

antibody

d death or MI

30 d death

death or MI

30 d death

d death or MI

II 30 d

 

30 d death

death or MI 0.2

pooled studies stratifying

(PRIMO-

of PRIMO I (3,099

 

binding to C5

323/2130

or MI

341/2098

or MI

-0.011

death or

 

or MI

 

patients by < or ≥2%

CABG I and II

CABG patients at

 

complement

Combined 30

15.3%

 

16.3%

 

MI

-

-0.233 to

 

expected STS mortality

trials) (9)

205 centers in

 

aimed at

d mortality

 

 

 

 

0.072

 

0.068

 

noted significant reduction

 

North American

 

inhibiting

 

 

 

 

 

 

 

 

 

in 30 d mortality in treated

 

and Europe from

 

formation of

 

 

 

 

 

 

 

 

 

pts (5.7 vs. 8.1%; p=0.024)

 

2002 to 2003) and

 

the membrane

 

 

 

 

 

 

 

 

 

 

 

PRIMO II (4,254

 

attack complex

 

 

 

 

 

 

 

 

 

 

 

CABG patients at

 

responsible for

 

 

 

 

 

 

 

 

 

 

 

249 centers from

 

cell lysis

 

 

 

 

 

 

 

 

 

 

 

2004 to 2005)

 

 

 

 

 

 

 

 

 

 

 

 

ARR indicates absolute risk ratio; CABG, coronary artery bypass graft; CI, confidence interval; CV, cardiovascular; EXPEDITION, Expanding Alzheimer’s Disease Investigators; MC-1, pyridoxal 5’-phosphate; MEND-CABG II, MC- 1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial; MI, myocardial infarction; mPTP, mitochondrial permeability transition pore; NS, nonsignificant; Periop, perioperative; POD, Postoperative Day; PRIMO , Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery; RCT, randomized controlled trial; and REDCABG, Reduction in Cardiovascular and Cerebrovascular Events in High-Risk Subjects Undergoing Coronary Artery Bypass Graft Surgery Using Cardiopulmonary Bypass; RR, relative risk; and STS, Society of Thoracic Surgeons.

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 4. Preconditioning: Table 3 (Comparison of Meta-Analyses of Potential Cardioprotective Effects of Volatile Anesthetics for Patients Undergoing CABG)

Author

Inclusions

No. Studies/

MI; OR; 95% CI; P-Value

Troponin Release; OR; 95% CI; P-Value

Mortality; OR; 95% CI; P-Value

 

 

No. Patients

 

 

 

 

Symons et al.

HALO, ENF, ISO, SEVO,

27/2979

WMD OR: -3.87; 95% CI: -

OR -1.44 (95% CI: -2.34 to -0.55); p=0.002

OR 0.68 (95% CI: 0.32 to 1.47); p=0.33

2006 (10)

DES; on-/ off-pump

 

8.75,1.03; p=0.12

 

 

 

 

 

 

 

 

 

 

Yu et al. 2006

HALO, ENF, ISO, SEVO,

32/2841

OR: 1.34; 95% CI: 0.68 to 2.64;

WMD: (SEVO,DES) OR: -1.45; 95% CI: -1.73 to -1.16;

OR: 0.65; 95%

CI: 0.36 to 1.18; p=0.16

(11)

DES; on-pump

 

p=0.40

p<0.00001

 

 

 

 

 

 

 

 

 

Landoni et al.

SEVO, DES; on-/off-pump

22/1922

OR: 0.51; 95% CI: 0.32 to 0.84; p for

Not reported

OR: 0.31; 95%

CI: 0.12 to 0.80; p for effect=0.02

2007 (12)

 

 

effect=0.008

 

 

 

 

 

 

 

 

 

 

Yao et al. 2009

SEVO; on-/off-pump

13/696

Not reported

WMD: OR: -0.82; 95% CI: -0.87 to -0.85; p=0.0002

OR: 0.32; 95%

CI: 0.03 to 3.19; p=0.33

(13)

 

 

 

 

 

 

 

 

 

 

 

 

 

CI indicates confidence interval; DES indicates desflurane; ENF, enflurane; HALO, halothane; ISO, isoflurane; MI, myocardial infarction; OR, odds ratio; SEVO, sevoflurane; and WMD, weighted mean difference.

Data Supplement 5. CABG in Patients With Acute MI

Study Name

Study Type

Patient Population

Findings

Statistical Significance

 

 

Sample Size

 

 

Thielmann et al. 2007

Observational

138 STEMI unresponsive to

In-hospital mortality:

p<0.01

(14)

Study

nonsurgical therapy

23.8% when CABG was performed between 7 to 23 h

 

 

 

 

6.7% when performed at 1 to 3 d

 

 

 

 

4.2% when performed at 4 to 7 d

 

 

 

 

2.4% when performed at 8 to 14 d

 

 

 

 

Independent predictors of in-hospital death were female gender and preoperative cTnI level

 

Alexiou et al. 2008 (15)

Observational

220 with ACS; 35 (15.9%) with

In-hospital mortality was 8.5%

p<0.0007

 

Study

STEMI

Mean time from onset of symptoms to CABG differed between survivors (5.1±2.7 h) and

 

 

 

 

nonsurvivors (11.4±3.2 h)

 

 

 

 

Independent predictors of mortality were age >75 y (OR: 5.36; 95% CI: 1.64 to 21.68;

 

 

 

 

p=0.028), COPD (OR: 23.04; 95% CI: 4.33 to 158.61; p=0.003), and renal disease (OR: 7.01;

 

 

 

 

95% CI: 1.81 to 34.62; p=0.007)

 

Filizcan et al. 2011 (16)

Observational

150 (114 survived, 36 died)

Overall in-hospital mortality was 22% patients who underwent CABG ≤6 h (6.1%)

 

 

Study

 

7 to 23 h (50%)

 

 

 

 

15 to 30 d (7.1%)

 

 

 

 

Predictors of in-hospital mortality were age (OR: 1.049; 95% CI: 1.013 to 1.087; p=0.008),

 

 

 

 

preoperative IABP (OR: 4.386; 95% CI: 1.381 to 13.933; p=0.012), and preoperative cTnl

 

 

 

 

(OR: 1.019; 95% CI: 1.002 to 1.036; p=0.027).

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.