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

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.