Background Long-term benefit of dual antiplatelet
therapy (
DAPT) over single antiplatelet
therapy (SAPT) for the prevention of recurrent
stroke has not been established in patients with intracranial arterial
stenosis. We compared the efficacy and safety of
DAPT with
cilostazol and
clopidogrel or
aspirin to those of SAPT with
clopidogrel or
aspirin in patients with intracranial arterial
stenosis, who were recruited to the
Cilostazol Stroke Prevention Study for Antiplatelet Combination trial, a randomized controlled trial in high-risk Japanese patients with
ischemic stroke. Methods and Results We compared the vascular and hemorrhagic events between
DAPT and SAPT in patients with
ischemic stroke and symptomatic or asymptomatic intracranial arterial
stenosis of at least 50% in a major intracranial artery. Patients were placed in two groups: 275 were assigned to receive
DAPT and 272 patients SAPT. The risks of
ischemic stroke (hazard ratio [HR], 0.47; 95% CI, 0.23-0.95); and composite of
stroke,
myocardial infarction, and vascular death (HR, 0.48; 95% CI, 0.26-0.91) were lower in
DAPT than SAPT, whereas the risk of severe or life-threatening
bleeding (HR, 0.72; 95% CI, 0.12-4.30) did not differ between the 2 treatment groups. Conclusions
DAPT using
cilostazol was superior to SAPT with
clopidogrel or
aspirin for the prevention of recurrent
stroke and vascular events without increasing
bleeding risk among patients with intracranial arterial
stenosis after
stroke. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01995370.