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Abstract

Why is this study important?
Aspirin has long been the recommended treatment for all atherothrombotic vascular diseases. The study S-ACCESS looked at the antiplatelet agent sarpogrelate, 2 (dimethylamino) 1 [[o(mmethoxyphenethyl)phenoxy]methyl] ethyl hydrogen succinate hydrochloride, that has been used for years to treat patients with peripheral arterial disease in Japan, China, and the Republic of Korea. It works as a selective 5-hydroxytryptamine (5-HT) receptor antagonist, inhibiting responses to 5 HT mediated by 5-HT2A receptors, including platelet aggregation and vasoconstriction.
Who were the participants?
1510 patients with recent cerebral infarction (1 week to 6 months after onset) were randomly assigned to receive either sarpogrelate (100 mg TID) or aspirin (81 mg/d). The study was conducted in 113 centres in Japan. Mean follow-up period was 1.59 years. The primary efficacy end point was recurrence of cerebral infarction. Clusters of serious vascular events (stroke, acute coronary syndrome, or vascular event-related death) were selected as secondary end points. The aim of the primary efficacy analysis was to demonstrate the noninferiority of sarpogrelate with respect to aspirin.
What were the outcomes?
Cerebral infarction recurred in 72 patients (6.09%/y) in the sarpogrelate group and in 58 (4.86%/y) in the aspirin group (hazard ratio=1.25; 95% CI, 0.89 to 1.77; P=0.19). A serious vascular event occurred in 90 (7.61%/y) and in 85 (7.12%/y) patients, respectively (hazard ratio=1.07; 95% CI, 0.80 to 1.44; P=0.65). The overall incidences of bleeding events were 89 (11.9%) and 131 (17.3%), respectively (P