Abstract

Background: The CSPS.com trial showed that dual antiplatelet therapy (DAPT) using cilostazol was superior to single antiplatelet therapy (SAPT) with aspirin or clopidogrel for the long-term prevention of recurrent ischemic stroke and vascular events in high-risk Japanese patients with ischemic stroke. We conducted a subgroup analysis of the CSPS.com trial in order to investigate the effects of extracranial or intracranial arterial stenosis on the benefit of cilostazol. Methods: We compared the risk of recurrent ischemic stroke and vascular events including stroke, myocardial infarction, and vascular death between DAPT with cilostazol and aspirin or clopidogrel and SAPT with aspirin or clopidogrel in patients with or without at least 50% stenosis of the extracranial or intracranial artery among patients recruited to the CSPS.com trial. Results: The median follow-up period was 1.4 years. The risk of recurrent stroke did not differ between DAPT and SAPT among 246 patients with extracranial arterial stenosis (8.04% vs 7.46%, HR 1.05, 95% CI 0.43-2.58), while it was lower in DAPT than in SAPT among 547 patients with intracranial arterial stenosis (5.8% vs 11.9%, HR 0.47, 95% CI 0.23-0.95), and among 944 patients without any arterial stenosis (2.91% vs 7.13%, HR 0.44, 95% CI 0.17-0.74). The risk of vascular events did not differ between DAPT and SAPT among patients with extracranial arterial stenosis (8.93% vs 8.96%, HR 0.97, 95% CI 0.42-2.24), while it was lower in DAPT than in SAPT among patients with intracranial arterial stenosis (7.70% vs 14.5%, HR 0.48, 95% CI 0.26-0.96), and among patients without any arterial stenosis (3.33% vs 7.56%, HR 0.47, 95% CI 0.26-0.85). The risk of major bleeding did not differ between DAPT and SAPT among any category of patients. Conclusions: DAPT using cilostazol might not be beneficial for the long-term prevention of recurrent stroke and vascular events in patients with extracranial arterial stenosis, while it might be beneficial in patients with intracranial arterial stenosis or in those without any arterial stenosis.

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