Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus‐eluting stent in real‐world Japanese patients with coronary artery disease (OPERA): Study design and rationale |
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| Authors: | Masato Nakamura MD Shinsuke Nanto MD Atsushi Hirayama MD Tadateru Takayama MD Masakatsu Nishikawa MD Kazuo Kimura MD Satoshi Morita PhD Tadanori Aizawa MD Ryuta Asano MD Yuji Matsumaru MD Chikuma Hamada PhD Takaaki Isshiki MD for the OPERA Steering Committee Investigators |
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| Affiliation: | 1. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan;2. Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan;3. Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan;4. Institute of Human Research Promotion and Drug Development, Mie University Faculty of Medicine, Tsu, Japan;5. Department of Cardiology, Yokohama City University Medical Center, Yokohama, Japan;6. Department of Epidemiology and Healthcare Research, Kyoto University School of Public Health, Kyoto, Japan;7. Department of Cardiology, The Cardiovascular Institute Hospital, Tokyo, Japan;8. Department of Cardiology, Sakakibara Memorial Hospital, Tokyo, Japan;9. Department of Endovascular Neurosurgery, Toranomon Hospital, Tokyo, Japan;10. Department of Management Science, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan;11. Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan |
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| Abstract: | ![]()
Background: In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline‐recommended 6–12 months after the implantation of drug‐eluting stents. However, no clinical grounds sufficient to rationalize the need are available. Objectives: To define the optimal duration of DAPT and to examine the safety and efficacy of the Endeavor zotarolimus‐eluting stent (E‐ZES) in real‐world Japanese patients with CAD. Study design: The present prospective, nonrandomized, multicenter, controlled study is uniquely designed to examine the analysis set to be formulated after integrating two different databases consisting of the following two study arms: the 3‐month DAPT arm, in which 1,210 patients were consecutively enrolled at 106 medical institutions; and the 12‐month DAPT arm, in which 1,210 patients will be consecutively extracted from the Endeavor Japan post‐marketing surveillance at 60 medical institutions. The primary endpoint is “net adverse cardiac and cerebrovascular events—death, myocardial infarction, cerebrovascular accident, and major bleeding)” at 12 months after implantation. The secondary endpoints are as follows: major adverse cardiac events at 1, 3, 6, 9, and 12 months after implantation; target vessel revascularization and target lesion revascularization at 9 and 12 months after implantation; and stent thrombosis, DAPT compliance, and bleeding events at 12 months after implantation. Noninferiority in the E‐ZES's profiles between the study arms will be investigated. Conclusions: The present study will provide insight into the optimal duration of DAPT after the E‐ZES implantation in individual, real‐world patients with CAD. © 2013 Wiley Periodicals, Inc. |
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| Keywords: | coronary artery disease dual antipalete therapy drug‐eluting stent major bleeding stent thrombosis |
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