{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T19:05:25Z","timestamp":1722884725213},"reference-count":35,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,12,31]],"date-time":"2013-12-31T00:00:00Z","timestamp":1388448000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:p>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\u2010recommended 6\u201312 months after the implantation of drug\u2010eluting 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\u2010eluting stent (E\u2010ZES) in real\u2010world 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\u2010month DAPT arm, in which 1,210 patients were consecutively enrolled at 106 medical institutions; and the 12\u2010month DAPT arm, in which 1,210 patients will be consecutively extracted from the Endeavor Japan post\u2010marketing surveillance at 60 medical institutions. The primary endpoint is \u201cnet adverse cardiac and cerebrovascular events\u2014death, myocardial infarction, cerebrovascular accident, and major bleeding)\u201d 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\u2010ZES'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\u2010ZES implantation in individual, real\u2010world patients with CAD. \u00a9 2013 Wiley Periodicals, Inc.<\/jats:p>","DOI":"10.1002\/ccd.25282","type":"journal-article","created":{"date-parts":[[2013,11,8]],"date-time":"2013-11-08T16:52:39Z","timestamp":1383929559000},"page":"368-374","source":"Crossref","is-referenced-by-count":2,"title":["Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus\u2010eluting stent in real\u2010world Japanese patients with coronary artery disease (OPERA): Study design and rationale"],"prefix":"10.1002","volume":"84","author":[{"given":"Masato","family":"Nakamura","sequence":"first","affiliation":[{"name":"Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinsuke","family":"Nanto","sequence":"additional","affiliation":[{"name":"Department of Advanced Cardiovascular Therapeutics Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Hirayama","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine Nihon University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadateru","family":"Takayama","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine Nihon University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masakatsu","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Institute of Human Research Promotion and Drug Development Mie University Faculty of Medicine Tsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuo","family":"Kimura","sequence":"additional","affiliation":[{"name":"Department of Cardiology Yokohama City University Medical Center Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Morita","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Healthcare Research Kyoto University School of Public Health Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadanori","family":"Aizawa","sequence":"additional","affiliation":[{"name":"Department of Cardiology The Cardiovascular Institute Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryuta","family":"Asano","sequence":"additional","affiliation":[{"name":"Department of Cardiology Sakakibara Memorial Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Matsumaru","sequence":"additional","affiliation":[{"name":"Department of Endovascular Neurosurgery Toranomon Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chikuma","family":"Hamada","sequence":"additional","affiliation":[{"name":"Department of Management Science, Faculty of Engineering Tokyo University of Science Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takaaki","family":"Isshiki","sequence":"additional","affiliation":[{"name":"Department of Cardiology Teikyo University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the OPERA Steering Committee and Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,12,31]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067731"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067484"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa066633"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067193"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.08.007"},{"key":"e_1_2_6_7_1","first-page":"e362","article-title":"American College of Cardiology Foundation\/American Heart Association Task Force on Practice G. 2013 ACCF\/AHA guideline for the management of ST\u2010elevation myocardial infarction: A report of the American College of Cardiology Foundation\/American Heart Association Task Force on Practice Guidelines","volume":"127","author":"O'Gara PT","year":"2013","journal-title":"Circulation"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq277"},{"key":"e_1_2_6_9_1","unstructured":"The Japanese Circulation Society Joint Working Group.Guidelines for management of Anticoagulant and antiplatelet therapy in cardiovascular disease (JCS 2009) [in Japanese].http:\/\/www.j\u2010circ.or.jp\/guideline\/pdf\/JCS2009_hori_h.pdf. 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