BACKGROUND: Early intervention is certainly a preferred strategy over conservative management in patients with post-infarction angina (PIA). But at times, it may not be feasible to intervene, especially if patient refuses for intervention. In a pilot study, we analyzed whether the addition of eptifibatide to intensified antianginal therapy would be of added benefit, in patients with PIA not willing to undergo intervention. METHODS: A total of 461 patients with PIA who refused intervention were randomized in a 1:1 manner to receive either eptifibatide along with intensification of antianginal therapy (group A; n = 229) or intensified antianginal therapy alone (group B; n = 232). The primary endpoints were composite of all-cause death and nonfatal myocardial infarction at 30 days. RESULTS: Primary composite endpoint did not differ between the two groups (16.2% vs. 18.9% in group A and group B, odds ratio [OR], 0.82; 95% CI, 0.5-1.30; P-value = 0.43). Significant earlier relief of angina (complete relief of angina within 12 h: 76% of patients in group A vs. 40.5% in group B; P-value <0.0001) was achieved in group A compared to group B. Although on Bleeding Academic Research Consortium (BARC) scale, type 1 and 2 bleeding was higher in group A (OR, 3.18; 95% CI, 1.76-5.74; P-value = 0.0001), the more serious (composite of type 3 and 5) bleeds did not show any difference (OR, 1.73; 95% CI, 0.7-4.08; P-value = 0.21). CONCLUSION: In patients with PIA who refused intervention, eptifibatide infusion resulted in earlier relief of angina albeit at the cost of increased non-life-threatening bleeding. Further, this effect was achieved in significantly higher number of patients receiving eptifibatide infusion when compared to patients not receiving it. Primary composite endpoints, however, did not differ in two groups, but being a pilot study, this needs to be confirmed by larger study of adequate sample size.
RCT Entities:
BACKGROUND: Early intervention is certainly a preferred strategy over conservative management in patients with post-infarction angina (PIA). But at times, it may not be feasible to intervene, especially if patient refuses for intervention. In a pilot study, we analyzed whether the addition of eptifibatide to intensified antianginal therapy would be of added benefit, in patients with PIA not willing to undergo intervention. METHODS: A total of 461 patients with PIA who refused intervention were randomized in a 1:1 manner to receive either eptifibatide along with intensification of antianginal therapy (group A; n = 229) or intensified antianginal therapy alone (group B; n = 232). The primary endpoints were composite of all-cause death and nonfatal myocardial infarction at 30 days. RESULTS: Primary composite endpoint did not differ between the two groups (16.2% vs. 18.9% in group A and group B, odds ratio [OR], 0.82; 95% CI, 0.5-1.30; P-value = 0.43). Significant earlier relief of angina (complete relief of angina within 12 h: 76% of patients in group A vs. 40.5% in group B; P-value <0.0001) was achieved in group A compared to group B. Although on Bleeding Academic Research Consortium (BARC) scale, type 1 and 2 bleeding was higher in group A (OR, 3.18; 95% CI, 1.76-5.74; P-value = 0.0001), the more serious (composite of type 3 and 5) bleeds did not show any difference (OR, 1.73; 95% CI, 0.7-4.08; P-value = 0.21). CONCLUSION: In patients with PIA who refused intervention, eptifibatide infusion resulted in earlier relief of angina albeit at the cost of increased non-life-threatening bleeding. Further, this effect was achieved in significantly higher number of patients receiving eptifibatide infusion when compared to patients not receiving it. Primary composite endpoints, however, did not differ in two groups, but being a pilot study, this needs to be confirmed by larger study of adequate sample size.