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Abstract WMP114: Safety and Efficacy of Prasugrel in Elderly/Low Bodyweight Japanese Patients With Ischemic Stroke: Randomized PRASTRO-II


 Background and Purpose:
 The safety of prasugrel in elderly and/or low body weight Japanese subjects who have a relatively high bleeding risk with antiplatelet therapy remains unknown. We aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic stroke.
 
 
 Methods:
 In this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic stroke were assigned to a prasugrel 3.75 mg group (PRA3.75), a prasugrel 2.5 mg group (PRA2.5), or a clopidogrel 50 mg group (CLO50) and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes.
 
 
 Results:
 A total of 654 subjects (age 76.4±7.3 years; body weight 55.6±9.3 kg; women 43.9%) were enrolled. The combined incidence of primary safety events was 4.2%, 1.9%, and 3.6% in the PRA3.75, PRA2.5, and CLO50 groups, respectively. The incidences of bleeding leading to treatment discontinuation were 2.3%, 0.9%, and 2.2% in the PRA3.75, PRA2.5, and CLO50 groups, respectively, while the incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was numerically lower but non-significant in patients treated with prasugrel than in patients treated with clopidogrel [0.0% (0/216), 3.3% (7/215), and 3.6% (8/223)].
 
 
 Conclusions:
 Elderly and/or low body weight Japanese patients with previous non-cardioembolic stroke who received prasugrel 3.75 mg showed similar results in terms of primary safety endpoint and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes compared with those who received clopidogrel 50 mg.
