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Influence of Timing of Clopidogrel Treatment on the Efficacy and Safety of Bivalirudin in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

An Analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial

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^¶¶ for the ACUITY of Trial Investigators^_*

^_* Cleveland Clinic Foundation, Cleveland, Ohio
Geisinger Clinic, Danville, Pennsylvania
The Medicines Company, Parsippany, New Jersey
The Sarah Cannon Research Institute and The Centennial Heart Center, Nashville, Tennessee
^|| Flinders Medical Center, Adelaide, Australia
^¶ Pennsylvania Hospital, University of Pennsylvania, Philadelphia, Pennsylvania
^# New York University School of Medicine, New York, New York
^_** Harvard University, Boston, Massachusetts
Hopital Cardiologique, Lille, France
Duke University Medical Center, Durham, North Carolina
University Hospital Gasthuisberg, Leuven, Belgium
^|||| Lehigh Valley Hospital, Allentown, Pennsylvania
^¶¶ Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York

^_* Reprint requests and correspondence: Dr. A. Michael Lincoff, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, J2-3, Cleveland, Ohio 44195 (Email: lincofa{at}ccf.org).

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)

Key Words: clopidogrel • acute coronary syndromes • anticoagulants • percutaneous coronary intervention • bivalirudin

Abbreviations and Acronyms   ACS = acute coronary syndrome   GP = glycoprotein   IV = intravenous   NSTE = non–ST-segment elevation   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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