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Chimeric 7E3 Antiplatelet Therapy in Unstable Angina Refractory to Standard Treatment - CAPTURE
Description:
Abciximab for death, MI and revascularization in percutaneous intervention.
Hypothesis:
To assess whether abciximab can improve outcome in patients with refractory unstable angina who are undergoing PTCA.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 1,266
Mean Follow Up: 6 months
Mean Patient Age: 61
Female: 28
Patient Populations:
Refractory unstable angina within 48 hours
Significant coronary disease with lesion amenable to angioplasty by angiography
Exclusions:
Recent MI
Persistent ischemia that required immediate intervention
Significant left main coronary or bypass graft disease
Surgery, GI, or GU bleeding within 6 weeks
Cerebrovascular accident within 2 years
Planned oral anticoagulation, dextran, or thrombolytics
Bleeding diathesis
Autoimmune disease
Thrombocytopenia
Primary Endpoints:
Death, MI, or urgent revascularization at 30 days
Drug/Procedures Used:
Abciximab bolus 0.25 mg/kg, followed by 10 mg/min infusion beginning 18-24h before PTCA until 1 hr afterward.
Concomitant Medications:
Aspirin, heparin, IV nitrates
Principal Findings:
The CAPTURE trial was suspended after 1265 of a planned 1400 patients were enrolled. The interim analysis revealed a 29% relative reduction in death, MI, and revascularization at 30 days(11.3% abciximab vs 15.9% placebo), with slightly more major bleeding events for patients receiving abciximab (3.8% vs. 1.9%).
At 6 months, the rate of death or MI was 9.2% in the abciximab group compared to 9.9% in the placebo group (OR 0.92; 95% CI 0.63 to 1.34).
The rate of 6-month death, MI, or revascularization was 30.6% in the abciximab group compared to 30.4% for the placebo group (OR 1.01; 95% CI 0.80, 1.29).
Interpretation:
Although some have characterized CAPTURE as an unstable angina trial, all patients received angiography prior to enrollment and percutaneous intervention. The significant result at 30 days resulted in early termination of the trial at its third interim analysis. The short course of abciximab did not affect the rate of recurrent myocardial infarction after the first few days. These results contrast with the EPIC study, which has shown a consistent reduction of revascularization at 6 months and 3 years after enrollment.
References:
1. Lancet 1997;349:1429-35. Final results
Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Immunoglobulin Fab Fragments, Angioplasty
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