Faculty Collaboration Database

Drug-induced thrombocytopenia and thrombosis: evidence from patients receiving an oral glycoprotein IIb/IIIa inhibitor in the Orbofiban in Patients with Unstable coronary Syndromes- (OPUS-TIMI 16) trial. J Thromb Thrombolysis 2006 Oct;22(2):95-102

Date

09/30/2006

Pubmed ID

17008974

DOI

10.1007/s11239-006-8669-4

Scopus ID

2-s2.0-33749162323 (requires institutional sign-in at Scopus site)   19 Citations

Abstract

OBJECTIVE: To assess etiology and impact of thrombocytopenia in a large oral glycoprotein (GP) IIb/IIIa inhibitor trial.

BACKGROUND: Heparin is known to cause thrombocytopenia, and in some of these patients thrombosis. GP IIb/IIIa inhibitors are also associated with thrombocytopenia.

METHODS: The Orbofiban in Patients with Unstable Coronary Syndromes (OPUS-TIMI 16) Trial randomized 10,392 patients with ACS to the oral GP IIb/IIIa inhibitor orbofiban or placebo. Patients were followed for a minimum of ten months. Thrombocytopenia was defined prospectively as a platelet count < 80,000.

RESULTS: Thrombocytopenia was rare in the OPUS-TIMI 16 trial (0.68% at Day 30 and 0.80% at 1 year), but more common in patients treated with orbofiban (0.92%) compared with those treated with placebo (0.2%), p < 0.001. Patients who developed thrombocytopenia had higher rates of death (11.6% vs. 1.7%, p < 0.001), recurrent MI (12.1% vs. 2.8%, p < 0.001), intracranial hemorrhage (2.9% vs. 0.0%, p < 0.001), and major or severe bleeding (19.0% vs. 2.0%, p < 0.001) at 30 days (with similar results at one year).

CONCLUSION: Thrombocytopenia, though uncommon, was associated with orbofiban use and an increased risk of bleeding, but also death and MI. This study provides further evidence that drugs that lead to thrombocytopenia are, in a significant proportion of patients associated with thrombotic events.

Author List

Scirica BM, Cannon CP, Cooper R, Aster RH, Brassard J, McCabe CH, Charlesworth A, Skene AM, Braunwald E

MESH terms used to index this publication - Major topics in bold

Aged
Alanine
Angina, Unstable
Aspirin
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction
Platelet Aggregation Inhibitors
Platelet Glycoprotein GPIIb-IIIa Complex
Pyrrolidines
Thrombocytopenia
Thrombosis