• Masato Nakamura, Shinsuke Nanto, Atsushi Hirayama, Tadateru Takayama, Masakatsu Nishikawa, Kazuo Kimura, Satoshi Morita, Tadanori Aizawa, Ryuta Asano, Yuji Matsumaru, Chikuma Hamada, Takaaki Isshiki, and OPERA Steering Committee and Investigators.
• Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
• Catheter Cardiovasc Interv. 2014 Sep 1; 84 (3): 368-74.

BackgroundIn 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.ObjectivesTo 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 DesignThe 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.ConclusionsThe 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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