Author + information
- Received September 10, 2008
- Revision received October 7, 2008
- Accepted October 10, 2008
- Published online December 1, 2008.
- A. Michael Lincoff, MD⁎,⁎ (, )
- Steven R. Steinhubl, MD†,‡,
- Steven V. Manoukian, MD§,
- Derek Chew, MD∥,
- Charles V. Pollack Jr, MD¶,
- Frederick Feit, MD#,
- James H. Ware, PhD⁎⁎,
- Michel E. Bertrand, MD††,
- E. Magnus Ohman, MD‡‡,
- Walter Desmet, MD§§,
- David A. Cox, MD∥∥,
- Roxana Mehran, MD¶¶,
- Gregg W. Stone, MD¶¶,
- ACUITY of Trial Investigators⁎
- ↵⁎Reprint requests and correspondence:
Dr. A. Michael Lincoff, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, J2-3, Cleveland, Ohio 44195
Objectives This study sought to determine if the efficacy of bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial.
Background The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events.
Methods Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), bivalirudin plus a GP IIb/IIIa inhibitor, or bivalirudin alone. Dose and timing of clopidogrel were left to the investigator's discretion.
Results Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel >30 min after PCI or not at all experienced an increase in ischemic events when randomized to bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with bivalirudin alone.
Conclusions This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
Funded by the Medicines Company, Parsippany, New Jersey. Dr. Lincoff has received research grants from the Medicines Company and Sanofi-Aventis. Dr. Steinhubl is an employee of the Medicines Company and was a consultant for Sanofi-Aventis, Diiachi Sankyo, Eli Lilly, and AstraZeneca. Dr. Manoukian is a consultant for Bristol-Myers Squibb, Medicure Pharma, Sanofi-Aventis, Schering-Plough, and the Medicines Company and is member of the Speakers' Bureau of and has received research grants from the Medicines Company. Dr. Pollack is a consultant for the Medicines Company, Sanofi-Aventis, and Schering-Plough; is a member of the Speakers' Bureau of Sanofi-Aventis, Schering-Plough, and Bristol Myers-Squibb; and has received research grants from Sanofi-Aventis and GlaxoSmithKline. Dr. Feit is a consultant for the Medicines Company and a shareholder of Millennium Pharmaceuticals, Johnson & Johnson, and the Medicines Company. Dr. Ware is a consultant for Biogen, InfraRedeX, Schering-Plough, Pfizer, and the Medicines Company. Dr. Ohman is a consultant for the Medicines Company, Inovise, Savacor, Liposcience, Response Biomedical, Datascope, and Abioed; has received 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. Desmet is a consultant for the Medicines Company and Nycomed and a member of the Speakers' Bureau of Sanofi-Aventis. Dr. Cox is a member of the Speakers' Bureau of the Medicines Company. Dr. Mehran has received research grants from the Medicines Company. Dr. Stone has received research grants from the Medicines Company and has received honoraria from Eli Lilly.
- Received September 10, 2008.
- Revision received October 7, 2008.
- Accepted October 10, 2008.
- American College of Cardiology Foundation