Addition of cilostazol to aspirin therapy for secondary prevention of cardiovascular and cerebrovascular disease in patients undergoing percutaneous coronary intervention: A randomized, open-label trial

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• 作者：Hiroshi Ueda ; MD^a ; ^{h.ueda998@nifty.com" class="auth_mail" title="E-mail the corresponding author} ; Atsumichi Kido ; MD^b ; Seiji Matsuhisa ; MD ; PhD^a ; Koichiro Asawa ; MD ; PhD^a ; Naohiro Yoshida ; MD^a ; Mitsuru Tsujimoto ; MD^c ; Yasushi Sasaki ; MD^a ; Yukiko Kuga ; MD ; PhD^a ; Masaki Yamasaki ; MD^a ; Kazuya Ueda ; MD^a ; Shoichi Shinohara ; MD^d ; Yasunori Nishida ; MD^a
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：173
• 期：Complete
• 页码：134-142
• 全文大小：595 K

文摘

Patients with established coronary artery disease are at increased risk for future ischemic events and require secondary prevention for systemic vascular disease. We performed a randomized clinical trial to evaluate the impact of cilostazol on cardiovascular and cerebrovascular disease in patients undergoing percutaneous coronary intervention.

Methods

A total of 514 patients who had undergone coronary stent implantation >6 months previously and were thought to no longer need dual antiplatelet therapy with aspirin and a thienopyridine were randomly assigned to receive aspirin plus cilostazol therapy or aspirin therapy alone after discontinuation of thienopyridine therapy. The primary efficacy end point was a composite of all-cause death, myocardial infarction, stroke, or cardiovascular or cerebrovascular revascularization at 2 years after randomization. The main safety end point was major or minor bleeding, according to the Thrombolysis in Myocardial Infarction bleeding definition.

Results

At 2 years, follow-up clinical data were available for 98.1% of patients. The primary efficacy end point occurred in 13.9% of the aspirin plus cilostazol group versus 22.1% of the aspirin-only group (hazard ratio 0.61, 95% CI 0.40-0.93, P = .021). The rate of major or minor bleeding was not significantly different between the aspirin plus cilostazol and aspirin-only groups (1.6% and 4.0%, respectively, hazard ratio 0.40, 95% CI 0.13-1.28, P = .12).

Conclusions

In patients who underwent coronary stent implantation, the addition of cilostazol to aspirin therapy was associated with lower rates of cardiovascular and cerebrovascular events at 2 years compared with aspirin monotherapy.