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Benefit of Clopidogrel in Patients With Acute Coronary Syndromes Without ST-Segment Elevation in Various Risk Groups - CURE Risk Stratification Substudy
Description:
Theh goal of this study was to assess the safety and efficacy of clopidogrel among patients with non-ST elevation acute coronary syndromes when stratified into various risk categories.
Study Design
Study Design:
Patients Enrolled: 12562
Patient Populations:
non-ST elevation acute coronary syndromes presenting within 24 horus of symptom onset
Primary Endpoints:
composite of cardiovascular death myocardial infarction stroke
Drug/Procedures Used:
Patients with non-ST elevation acute coronary syndromes (n=12,562) presenting within 24 hours of their symptom onset were randomized to receive either clopidogrel (300 mg followed by 75 mg daily) plus aspirin or placebo plus aspirin for 3 to 12 months. Patients were categorized into various risk-groups based on their Thrombolysis in Myocardial Infarction (TIMI) risk scores. Treatment effect was analyzed in these different risk groups.
Principal Findings:
The TIMI risk model was validated in the CURE population with moderately good discriminatory power (c statistic 0.634 for the primary outcome at 9 months). The primary outcome (composite of cardiovascular death, myocardial infarction, or stroke) increased proportionally with increasing TIMI risk score. The primary outcome occurred less frequently in the clopidogrel group compared to the placebo group in low-risk (TIMI score 0 to 2, 4.1% versus 5.7%; relative risk [RR], 0.71; 95% confidence interval [CI], 0.52 to 0.97; P=0.04), intermediate-risk (TIMI score 3 to 4, 9.8% versus 11.4%; RR, 0.85; 95% CI, 0.74 to 0.98; P=0.03), and high-risk (TIMI score 5 to 7, 15.9% versus 20.7%; RR, 0.73; 95% CI, 0.60 to 0.90; P=0.004) categories.
Interpretation:
Among low-, intermediate-, and high-risk patients with non-ST elevation acute coronary syndromes (as stratified by TIMI risk score) clopidogrel was associated with a reduction in composite of cardiovascular death, myocardial infarction and stroke. Unlike many other therapies for non-ST elevation acute coronary syndromes (low molecular heparin, glycoprotein GpIIbIIIa receptor antagonists, invasive strategy) that have shown benefits mainly in high-risk patients, clopidogrel appears to provide similar benefit across all risk strata, including the low risk patients. The cost-effectiveness of treating the low-risk group reamins to be determined.
References:
Budaj A, Yusuf S, Mehta SR, et al, for the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial Investigators. Benefit of Clopidogrel in Patients With Acute Coronary Syndromes Without ST-Segment Elevation in Various Risk Groups. Circulation 2002;106:1622-26.
Keywords: Risk, Myocardial Infarction, Acute Coronary Syndrome, Stroke, Platelet Aggregation Inhibitors, Heparin, Ticlopidine, Confidence Intervals, Purinergic P2Y Receptor Antagonists
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