Key result
Dual antiplatelet therapy using cilostazol significantly reduced the recurrence of ischemic stroke compared to monotherapy in male patients (HR 0.40) but not in female patients (HR 0.82).
Why the study?
Sex differences in the effects of antiplatelet therapy for secondary stroke prevention had not been clarified.
Does dual antiplatelet therapy using cilostazol reduce the recurrence of ischemic stroke in patients with high-risk, non-cardioembolic ischemic stroke compared to monotherapy?
RCT (n=1,879)
Open-label
1:1 ratio using a block-randomization scheme
Yes
Does dual antiplatelet therapy using cilostazol reduce the recurrence of ischemic stroke in patients with high-risk, non-cardioembolic ischemic stroke compared to monotherapy?
Long-term dual antiplatelet therapy with cilostazol significantly reduces ischemic stroke recurrence in male patients, but not in female patients, highlighting a potential sex-specific treatment effect.
Suggests DAPT benefit in males but not females post-stroke; extends RCT evidence for sex-specific effects and warrants confirmation.
AIM: Although some sex differences in stroke have been reported, differences in the effects of antiplatelet therapy for secondary stroke prevention have not been clarified. METHODS: In the Cilostazol Stroke Prevention Study combination trial, patients with high-risk, non-cardioembolic ischemic stroke between 8 and 180 days after onset treated with aspirin or clopidogrel alone were recruited and randomly assigned to receive either monotherapy or dual antiplatelet therapy (DAPT) using cilostazol and followed up for 0.5-3.5 years. The primary efficacy outcome was recurrence of ischemic stroke. The safety outcome was severe or life-threatening hemorrhage. Outcomes were analyzed by sex. RESULTS: A total of 1,320 male patients and 558 female patients were included. The male patients had more risk factors than the female patients. In male patients, the primary endpoint occurred at a rate of 2.0 per 100 patient-years in the DAPT group and 5.1 per 100 patient-years in the monotherapy group (hazard ratio (HR), 0.40; 95% confidence interval (CI), 0.23-0.68). In male patients, DAPT prolonged the time to recurrent stroke by 4.02-fold (95% CI, 1.63-9.96) compared with monotherapy. In female patients, the average annual event rates were 2.7 per 100 patient-years in the DAPT group and 3.3 per 100 patient-years in the monotherapy group (HR, 0.82; 95% CI, 0.37-1.84). Safety outcomes did not differ significantly in both male and female patients. CONCLUSIONS: Long-term DAPT using cilostazol reduced the recurrence of ischemic stroke and prolonged the recurrence-free time in male patients, but not in female patients.
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Hoshino et al. (2022) conducted an RCT in High-risk, non-cardioembolic ischemic stroke (n=1,879). Dual antiplatelet therapy (cilostazol plus aspirin or clopidogrel) vs. Monotherapy (aspirin or clopidogrel alone) was evaluated on First recurrence of ischemic stroke (results shown for male patients) (HR 0.40, 95% CI 0.23-0.68). Dual antiplatelet therapy using cilostazol significantly reduced the recurrence of ischemic stroke compared to monotherapy in male patients (HR 0.40) but not in female patients (HR 0.82).
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