Indobufen resulted in a 10.6% incidence of major vascular events compared to 9.0% with warfarin over 12 months, with no statistically significant difference between treatments.
RCT (n=916)
randomized
Yes
Does indobufen prevent major vascular events compared to warfarin in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia?
Indobufen showed no statistically significant difference in efficacy compared to warfarin for secondary prevention in NRAF patients, with potentially fewer gastrointestinal bleeding events, offering a possible alternative when oral anticoagulants are contraindicated.
Absolute Event Rate: 10.6% vs 9%
BACKGROUND AND PURPOSE: The results of a large prospective randomized trial have shown the efficacy of oral anticoagulation in the secondary prevention of major vascular events in patients with nonrheumatic atrial fibrillation (NRAF); less well established is the role of antiplatelet agents. The present study compared the effects of indobufen, a reversible inhibitor of platelet cyclooxygenase, with those of warfarin in this setting. METHODS: A total of 916 patients with NRAF and a recent (< or = 15 days) cerebral ischemic episode were admitted to this multicenter, randomized study, during which they were treated with either indobufen (100 or 200 mg BID) or warfarin (to obtain an international normalized ratio of 2.0 to 3.5) for 12 months. The two groups (462 on indobufen and 454 on warfarin) were well balanced in terms of their main baseline characteristics. The primary outcome of the study was the combined incidence of nonfatal stroke (including intracerebral bleeding), pulmonary or systemic embolism, nonfatal myocardial infarction, and vascular death. RESULTS: At the end of follow-up, the incidence of primary outcome events was 10.6% in the indobufen group (95% confidence interval, 7.7% to 13.5%) and 9.0% in the warfarin group (95% confidence interval, 6.3% to 11.8%), with no statistically significant difference between treatments. The frequency of noncerebral major bleeding complications was low: only four cases (0.9%) of gastrointestinal bleeding were observed, all of them in the warfarin group. CONCLUSIONS: We conclude that, within the limitations of its design, this study may help the medical community in devising appropriate antithrombotic strategies for NRAF patients for whom oral anticoagulants are contraindicated or do not represent a feasible approach to treatment.
Morocutti et al. (Thu,) conducted a rct in Nonrheumatic atrial fibrillation (NRAF) with recent cerebral ischemia (n=916). Indobufen vs. Warfarin (INR 2.0 to 3.5) was evaluated on Combined incidence of nonfatal stroke (including intracerebral bleeding), pulmonary or systemic embolism, nonfatal myocardial infarction, and vascular death. Indobufen resulted in a 10.6% incidence of major vascular events compared to 9.0% with warfarin over 12 months, with no statistically significant difference between treatments.