BACKGROUND:Cilostazol has been widely used to prevent peripheral vascular events, and its antiplatelet mechanisms may different from aspirin and clopidogrel. We hypothesized that cilostazol in addition to aspirin and clopidogrel effectively reduces systemic ischemic events after percutaneous coronary intervention (PCI) in high-risk patients. METHODS: In this prospective study, 1,212 patients with acute coronary syndromes were randomly assigned to receive either standard dual-antiplatelet treatment with aspirin and clopidogrel (n = 608) or triple-antiplatelet therapy with the addition of a 6-month course of cilostazol (n = 604) after successful PCI. The primary end point was a composite of cardiac death, nonfatal myocardial infarction, stroke, or target vessel revascularization (TVR) at 1 year after randomization. The secondary end points were TVR and hemorrhagic events. RESULTS: Triple-antiplatelet treatment was associated with a significantly lower incidence of the primary end points (10.3% vs 15.1%; P = .011). The need for TVR was similar between patients who received triple- and dual-antiplatelet treatment (7.9% vs 10.7%; P = .10). Multivariate analysis showed that female patients and clinically or angiographically high-risk patients benefited more from the triple-antiplatelet treatment. There were no significant differences between the 2 regimens in terms of the risks for major and minor bleeding. CONCLUSIONS: For patients with acute coronary syndromes, triple-antiplatelet therapy consisting ofcilostazol, aspirin, and clopidogrel reduced long-term cardiac and cerebral events after PCI, especially for patients with high-risk profiles.
RCT Entities:
BACKGROUND:Cilostazol has been widely used to prevent peripheral vascular events, and its antiplatelet mechanisms may different from aspirin and clopidogrel. We hypothesized that cilostazol in addition to aspirin and clopidogrel effectively reduces systemic ischemic events after percutaneous coronary intervention (PCI) in high-risk patients. METHODS: In this prospective study, 1,212 patients with acute coronary syndromes were randomly assigned to receive either standard dual-antiplatelet treatment with aspirin and clopidogrel (n = 608) or triple-antiplatelet therapy with the addition of a 6-month course of cilostazol (n = 604) after successful PCI. The primary end point was a composite of cardiac death, nonfatal myocardial infarction, stroke, or target vessel revascularization (TVR) at 1 year after randomization. The secondary end points were TVR and hemorrhagic events. RESULTS: Triple-antiplatelet treatment was associated with a significantly lower incidence of the primary end points (10.3% vs 15.1%; P = .011). The need for TVR was similar between patients who received triple- and dual-antiplatelet treatment (7.9% vs 10.7%; P = .10). Multivariate analysis showed that female patients and clinically or angiographically high-risk patients benefited more from the triple-antiplatelet treatment. There were no significant differences between the 2 regimens in terms of the risks for major and minor bleeding. CONCLUSIONS: For patients with acute coronary syndromes, triple-antiplatelet therapy consisting of cilostazol, aspirin, and clopidogrel reduced long-term cardiac and cerebral events after PCI, especially for patients with high-risk profiles.