TY - JOUR
T1 - Outcomes Following Pre-Operative Clopidogrel Administration in Patients With Acute Coronary Syndromes Undergoing Coronary Artery Bypass Surgery. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial
AU - Ebrahimi, Ramin
AU - Dyke, Cornelius
AU - Mehran, Roxana
AU - Manoukian, Steven V.
AU - Feit, Frederick
AU - Cox, David A.
AU - Gersh, Bernard J.
AU - Ohman, E. Magnus
AU - White, Harvey D.
AU - Moses, Jeffrey W.
AU - Ware, James H.
AU - Lincoff, A. Michael
AU - Stone, Gregg W.
N1 - Funding Information:
Dr. Ebrahimi is a consultant and member of the Speakers' Bureau and advisory board for Sanofi-Aventis and Bristol-Myers Squibb, and is a member of the Speakers' Bureau for The Medicines Company. Dr. Dyke is a consultant for The Medicines Company and is on the Speakers' Bureau of Sanofi-Aventis and Bristol-Myers Squibb. Dr. Mehran has received honoraria from and been a consultant for The Medicines Company, Lily/Daiichi Sankyo, Boston Scientific Corp., Cordis, Abbott, Medtronic, and Bracco, and has received research support from Sanofi-Aventis. Dr. Manoukian is a consultant for The Medicines Company, Bristol-Myers Squibb, Medicure Pharma, Sanofi-Aventis, and Schering-Plough. Dr. Feit is a consultant for the Medicines Company and a shareholder of Millennium Pharmaceuticals, Johnson & Johnson, and The Medicines Company. Dr. Cox is a consultant for The Medicines Company. Dr. Gersh is an advisory board member for AstraZeneca, Bristol-Myers Squibb, Abbott Laboratories, and Boston Scientific Corp., and is a shareholder in CV Therapeutics. Dr. Ohman is a consultant for The Medicines Company, Inovise, Savacor, Liposcience, Response Biomedical, Datascope, and Abioed; is in receipt of research grants from Sanofi-Aventis, Bristol-Myers Squibb, Eli Lilly, Sanofi-Aventis, Berlex, and Millennium Pharmaceuticals; is on the Speakers' Bureau of Schering-Plough and CV Therapeutics; and is a shareholder of Inovise, Savacor, and Medtronic. Dr. White is in receipt of research grants from The Medicines Company, Sanofi-Aventis, Proctor & Gamble, Schering-Plough, Eli Lilly, Alexion, Merck, Neuren Pharmaceuticals, GlaxoSmithKline, Pfizer, Roche, Fournier Laboratories, and Johnson & Johnson, and has received consulting fees from The Medicines Company and Sanofi-Aventis. Dr. Ware serves as a statistical consultant to The Medicines Company but receives no personal income. Dr. Lincoff has received research grants from The Medicines Company. Dr. Stone has received research grants from The Medicines Company, Abbott Vascular, and Boston Scientific.
PY - 2009/5/26
Y1 - 2009/5/26
N2 - Objectives: This study sought to evaluate the impact of upstream clopidogrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) requiring coronary artery bypass grafting (CABG) from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background: Despite benefits of clopidogrel in patients with NSTE-ACS undergoing percutaneous coronary intervention, this agent is often not administered upstream (before angiography) as recommended by the American College of Cardiology/American Heart Association guidelines because of potential bleeding in the minority of patients who require CABG. Methods: The ACUITY trial enrolled 13,819 patients with NSTE-ACS undergoing early invasive management. The timing of clopidogrel initiation was per investigator discretion. A 5-day washout period before CABG was recommended for patients having received clopidogrel. Results: Of 13,819 patients enrolled, 1,539 (11.1%) underwent CABG before discharge. Clopidogrel-exposed patients had a longer median duration of hospitalization (12.0 days vs. 8.9 days, p < 0.0001), but fewer adverse composite ischemic events (death, myocardial infarction, or unplanned revascularization) at 30 days; 12.7% vs. 17.3%, p = 0.01), with nonsignificantly different rates of non-CABG-related major bleeding (3.4% vs. 3.2%, p = 0.87) and post-CABG major bleeding (50.3% vs. 50.9%, p = 0.83) compared with those patients not administered clopidogrel. By multivariable analysis, clopidogrel use before CABG was an independent predictor of reduced 30-day composite ischemia (odds ratio: 0.67, 95% confidence interval: 0.48 to 0.92, p = 0.001) but not of increased post-CABG major bleeding (odds ratio: 0.98, 95% confidence interval: 0.80 to 1.19, p = 0.80). Conclusions: Clopidogrel administration before catheterization in patients with NSTE-ACS requiring CABG is associated with significantly fewer 30-day adverse ischemic events without significantly increasing major bleeding, compared to withholding clopidogrel until after angiography. These findings support the American College of Cardiology/American Heart Association guidelines for upstream clopidogrel administration in all NSTE-ACS patients, including those who subsequently undergo CABG. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).
AB - Objectives: This study sought to evaluate the impact of upstream clopidogrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) requiring coronary artery bypass grafting (CABG) from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. Background: Despite benefits of clopidogrel in patients with NSTE-ACS undergoing percutaneous coronary intervention, this agent is often not administered upstream (before angiography) as recommended by the American College of Cardiology/American Heart Association guidelines because of potential bleeding in the minority of patients who require CABG. Methods: The ACUITY trial enrolled 13,819 patients with NSTE-ACS undergoing early invasive management. The timing of clopidogrel initiation was per investigator discretion. A 5-day washout period before CABG was recommended for patients having received clopidogrel. Results: Of 13,819 patients enrolled, 1,539 (11.1%) underwent CABG before discharge. Clopidogrel-exposed patients had a longer median duration of hospitalization (12.0 days vs. 8.9 days, p < 0.0001), but fewer adverse composite ischemic events (death, myocardial infarction, or unplanned revascularization) at 30 days; 12.7% vs. 17.3%, p = 0.01), with nonsignificantly different rates of non-CABG-related major bleeding (3.4% vs. 3.2%, p = 0.87) and post-CABG major bleeding (50.3% vs. 50.9%, p = 0.83) compared with those patients not administered clopidogrel. By multivariable analysis, clopidogrel use before CABG was an independent predictor of reduced 30-day composite ischemia (odds ratio: 0.67, 95% confidence interval: 0.48 to 0.92, p = 0.001) but not of increased post-CABG major bleeding (odds ratio: 0.98, 95% confidence interval: 0.80 to 1.19, p = 0.80). Conclusions: Clopidogrel administration before catheterization in patients with NSTE-ACS requiring CABG is associated with significantly fewer 30-day adverse ischemic events without significantly increasing major bleeding, compared to withholding clopidogrel until after angiography. These findings support the American College of Cardiology/American Heart Association guidelines for upstream clopidogrel administration in all NSTE-ACS patients, including those who subsequently undergo CABG. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).
KW - acute coronary syndromes
KW - clopidogrel
KW - coronary artery bypass surgery
UR - https://www.scopus.com/pages/publications/65549120672
U2 - 10.1016/j.jacc.2009.03.006
DO - 10.1016/j.jacc.2009.03.006
M3 - Article
C2 - 19460609
AN - SCOPUS:65549120672
SN - 0735-1097
VL - 53
SP - 1965
EP - 1972
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 21
ER -