Cilostazol for primary prevention of stroke in peripheral artery disease: a population-based longitudinal study in Taiwan.

BACKGROUND: Clopidogrel, cilostazol, and aspirin were compared in terms of efficacy and safety for primary prevention of stroke in peripheral artery disease (PAD) patients.

METHODS: This retrospective cohort study analyzed data contained in the Taiwan National Health Insurance Bureau database for patients treated for PAD but not for stroke during 2002-2008. Patients were stratified according to treatment with aspirin, clopidogrel, cilostazol, or combined therapy. The primary efficacy and safety endpoints were stroke and hemorrhage.

RESULTS: Of the 931 patients enrolled in this study, 479 had received aspirin, 39 had received clopidogrel, 294 had received cilostazol alone, and 33 had received a cilostazol-based combined therapy. Compared to patients treated with aspirin, the patients treated with cilostazol had significantly lower all-stroke risk not only in the overall group (HR=0.66, 95% CI=0.48-0.90, p=0.0086), but also in the subgroup of patients with diabetes (HR=0.64, 95% CI=0.42-0.98, p=0.0394) and in the subgroup of patients with high cardiovascular risk (HR=0.66, 95% CI=0.46-0.95, p=0.0254). Additionally, compared to patients treated with aspirin, those treated with cilostazol did not have significantly more hemorrhagic events in the overall group, in the diabetes subgroup, or in the high cardiovascular risk subgroup. Clopidogrel, cilostazol-based combined therapy and aspirin did not significantly differ in terms of efficacy and hemorrhagic events.

CONCLUSION: Although this database study indicated that cilostazol therapy is an effective alternative treatment for primary prevention of stroke in PAD, further confirmation is needed in large, prospective, and randomized trials.