Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event.
C Michael Gibson, P Gabriel Steg, M Cecilia Bahit et al.
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In 30 seconds
This phase 3, multicentre, randomised, placebo-controlled trial tested milvexian added to standard antiplatelet therapy in patients treated within 7 days after an acute coronary syndrome event. The trial was stopped for futility after a planned interim analysis. At a median follow-up of 12.2 months, cardiovascular death, myocardial infarction, or ischemic stroke occurred in 5.4% with milvexian and 5.1% with placebo (hazard ratio, 1.05; 95% confidence interval, 0.91 to 1.21; P = 0.50). Intracranial or fatal bleeding was similarly uncommon in both groups.
Key findings
- The primary efficacy outcome occurred in 384 patients (5.4%) with milvexian and 365 (5.1%) with placebo (hazard ratio, 1.05; 95% confidence interval, 0.91 to 1.21; P = 0.50).
- BARC type 3c or 5 bleeding occurred in 23 patients (0.3%) with milvexian and 22 (0.3%) with placebo (P = 0.88).
- The trial was terminated for futility after a planned interim analysis based on 556 adjudicated efficacy end points.
Why it matters
The findings do not support an efficacy benefit from adding milvexian to antiplatelet therapy for preventing cardiovascular death, myocardial infarction, or ischemic stroke after acute coronary syndrome. The similar observed rates of severe bleeding are relevant to safety assessment, but do not offset the absence of demonstrated efficacy in this trial.
What to keep in mind
The trial was terminated for futility, and median follow-up was 12.2 months; longer-term effects are not established by these results.