Incremental Effect of Clopidogrel on Important Outcomes in Patients with Cardiovascular Disease
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ORIGINAL RESEARCH ARTICLE
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Incremental Effect of Clopidogrel on Important Outcomes in Patients with Cardiovascular Disease A Meta-Analysis of Randomized Trials Thomas J. Helton,1 Anthony A. Bavry,1 Dharam J. Kumbhani,2 Sandeep Duggal,1 Henri Roukoz1 and Deepak L. Bhatt1 1 2
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA Department of Internal Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Abstract
Objectives: To quantify the impact of clopidogrel plus aspirin on the individual outcomes of death, myocardial infarction, or stroke in patients with established cardiovascular disease, or in patients with multiple risk factors for vascular disease. Background: Randomized trials have demonstrated a reduction in composite outcomes when clopidogrel is added to aspirin therapy in patients with coronary artery disease; however, the magnitude of benefit on individual outcomes is unknown. Methods: We conducted a meta-analysis on randomized, controlled trials that compared aspirin plus clopidogrel with aspirin plus placebo for the treatment of coronary artery disease. Results: This analysis included five randomized trials (CURE, CREDO, CLARITY, COMMIT, and CHARISMA) in 79 624 patients. The incidence of all-cause mortality was 6.3% in the aspirin plus clopidogrel group versus 6.7% in the aspirin group (odds ratio [OR] 0.94; 95% CI 0.89, 0.99; p = 0.026). The incidence of myocardial infarction was 2.7% and 3.3% (OR 0.82; 95% CI 0.75, 0.89; p < 0.0001), and stroke was 1.2% and 1.4% (OR 0.82; 95% CI 0.73, 0.93; p = 0.002). Similarly, the incidence of major bleeding was 1.6% and 1.3% (OR 1.26; 95% CI 1.11, 1.41; p < 0.0001), and fatal bleeding was 0.28% and 0.27% (OR 1.04; 95% CI 0.76, 1.43; p = 0.79). Conclusion: The addition of clopidogrel to aspirin results in a small reduction in all-cause mortality in patients with ST-elevation myocardial infarction and a modest reduction in myocardial infarction and stroke in patients with cardiovascular disease. The overall incidence of major bleeding however is increased, although there is no excess of fatal bleeds or hemorrhagic strokes.
The use of aspirin (acetylsalicylic acid) in patients with coronary artery disease has long been considered the standard of care.[1] Aspirin compared with placebo has been shown to reduce mortality across the spectrum of cardiovascular disease.[2] Despite this significant reduction in mortality when aspirin is used for secondary prevention, adverse outcomes are still common. This was illustrated in the PURSUIT trial[3] (see table I for definitions of trial/study acronyms), where patients with non-ST-elevation unstable coronary syndromes were treated aggressively with aspirin, heparin, and a glycoprotein IIb/IIIa inhibitor, in conjunction with
appropriate reperfusion therapy. Despite this aggressive therapy, the incidence of death or nonfatal myocardial infarction up to 30 days after the index event in the most aggressively treated group was still
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