Clinical Investigation
Interventional Cardiology
Cilostazol in addition to aspirin and clopidogrel improves long-term outcomes after percutaneous coronary intervention in patients with acute coronary syndromes: A randomized, controlled study

https://doi.org/10.1016/j.ahj.2009.01.006Get rights and content

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.

Section snippets

Methods

The trial was approved by the ethics committee of Shenyang Northern Hospital, and all patients provided written informed consent.

Baseline characteristics

The demographic and clinical details of the 1,212 patients are presented in Table I. There were no significant differences between the baseline characteristics of the 2 groups. Concomitant medication regimen did not differ significantly between the groups.

Angiographic and procedural results

Lesion features and procedural results were similar between the 2 groups, as shown in Table II. There were 302 (49.7%) patients in the dual-antiplatelet therapy group and 328 (54.3%) patients in the triple-antiplatelet therapy group received

Discussion

Cilostazol is considered to be an optional substitute to clopidogrel in poor responders because its antiplatelet effect is via mechanism of suppressing cyclic adenosine monophosphate degradation.7 In selected patients, the safety and efficacy of cilostazol for the prevention of major adverse cardiac events after PCI were comparable to those of the P2Y12 antagonists.11, 12, 13, 14 However, several clinical studies have reported that combination of cilostazol and aspirin was associated with a

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    Randomized clinical trial no. NCT00404716.

    The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.

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