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J Am Coll Cardiol, 1998; 32:311-319 © 1998 by the American College of Cardiology Foundation |
a Divisions of Hematology/Coagulation and Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA
* Section of Cardiology, Wake Forest University, Winston-Salem, North Carolina, USA
Department of Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio, USA
Manuscript received February 19, 1998; revised manuscript received April 7, 1998, accepted April 23, 1998.
Address for correspondence: Dr. Scott D. Berkowitz, Divisions of Hematology/Coagulation and Cardiology, Department of Medicine, Box 3471, Duke University Medical Center, Durham, North Carolina 27710
berko005{at}mc.duke.edu
Objectives. This study sought to determine the frequency of thrombocytopenia and its relation with clinical outcomes in high risk patients undergoing percutaneous coronary revascularization who received either the platelet glycoprotein (GP) IIb/IIIa receptor antagonist abciximab (ReoPro, c7E3 Fab) or conventional therapy.
Background. The development of thrombocytopenia on exposure to GPIIb/IIIa antagonists threatens the utility and economic viability of this drug class for patients with vascular disease.
Methods. We analyzed data from the Evaluation of c7E3 for the Prevention of Ischemic Complications trial (EPIC), a 2,099-patient, randomized trial of placebo, abciximab bolus or abciximab bolus plus a 12-h infusion during high-risk coronary revascularization.
Results. Thrombocytopenia (nadir platelet count <100 x 109/liter) developed in 81 patients (3.9%) during their hospital stay, with 19 (0.9%) developing severe (<50 x 109/liter) thrombocytopenia. Both thrombocytopenia and severe thrombocytopenia were more frequent in the bolus-plus-infusion arm (5.2% and 1.6%, respectively) than in the bolus-only and placebo arms combined (p = 0.020 and p = 0.025, respectively). Acute profound thrombocytopenia developed in two patients in the bolus-plus-infusion arm. Patients with thrombocytopenia experienced more unfavorable clinical outcomes than those who did not develop thrombocytopenia, regardless of treatment assignment, but those with thrombocytopenia who received abciximab had fewer worse outcomes at 30 days. Multivariable logistic modeling revealed a lower baseline platelet count, older age and lighter weight to be important predictors of thrombocytopenia. In a logistic regression model, bolus-plus-infusion treatment was a significant predictor of thrombocytopenia (p = 0.016) and remained so after adjustment for procedures and baseline risk factors (p = 0.0077).
Conclusions. Thrombocytopenia was associated with adverse clinical outcomes and excessive bleeding, but patients receiving abciximab fared better than those receiving placebo.
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