Abstract 13371: Frequency and Clinical Impact of Nuisance Bleeding Among Patients Receiving Aspirin and Clopidogrel: Insights from the Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial
Background: Major bleeding is a common complication among patients presenting with non-ST-elevation acute coronary syndromes (NSTE-ACS), and is associated with increased cardiovascular morbidity and mortality. However, the frequency and prognostic implications of less severe, or nuisance, bleeding has not been well characterized.
Methods: We compared differences in bleeding severity and the impact of bleeding on adverse events among participants (n=12,562) in the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial. Patients presenting with NSTE-ACS were treated with aspirin and randomized to clopidogrel or placebo, and were followed-up for 1 year. We defined nuisance bleeding as bruising, epistaxis, hematuria, gastrointestinal hemorrhage or hematoma that did not meet the criteria of major or minor bleeding as defined by the trial protocol. Independent associations between bleeding and adverse events were assessed with multivariable logistic regression.
Results: Nuisance bleeding was more common among patients randomized to clopidogrel plus aspirin compared to placebo plus aspirin (5.98% vs 3.49%; P < 0.001). The number of patients with major, minor and nuisance bleeding was 212 (1.2%), 457 (3.6%) and 599 (4.8%), respectively. The cumulative frequencies of death (5.89% vs 5.97%; P = 0.68), death or myocardial infarction (MI; 9.11% vs 10.20%; P = 0.42), and death, MI or stroke (9.66% vs 11.01%; P = 0.34) did not differ between patients with and without nuisance bleeding (Figure). Associations were unchanged after multivariable adjustment and remained consistent across treatment arms.
Conclusion: Although common, nuisance bleeding is not associated with increased risk for death, MI or stroke among patients presenting with NSTE-ACS treated with clopidogrel plus aspirin.
- © 2011 by American Heart Association, Inc.