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Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial
DC Field | Value | Language |
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dc.contributor.author | Lee, Joo Myung | - |
dc.contributor.author | Park, Sang-Don | - |
dc.contributor.author | Lim, Sang Yup | - |
dc.contributor.author | Doh, Joon-Hyung | - |
dc.contributor.author | Cho, Jin Man | - |
dc.contributor.author | Kim, Ki-Seok | - |
dc.contributor.author | Bae, Jang-Whan | - |
dc.contributor.author | Chung, Woo-Young | - |
dc.contributor.author | Youn, Tae-Jin | - |
dc.date.accessioned | 2014-04-07T00:52:34Z | - |
dc.date.available | 2014-04-07T00:52:34Z | - |
dc.date.issued | 2013-11-20 | - |
dc.identifier.citation | Trials Vol.14, pp.1-6 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://hdl.handle.net/10371/91353 | - |
dc.description | Trial registration : Clinicaltrials.gov NCT01826552 | ko_KR |
dc.description.abstract | Background : The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.
Methods/design : The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction). Discussion : The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease. | ko_KR |
dc.description.sponsorship | This study is supported by a grant from Biotronik Korea. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central Ltd | - |
dc.subject | Drug-eluting stent | ko_KR |
dc.subject | Orsiro hybrid stent | ko_KR |
dc.subject | Zotarolimus-eluting stent | ko_KR |
dc.subject | Coronary heart disease | ko_KR |
dc.title | Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 이주명 | - |
dc.contributor.AlternativeAuthor | 박상돈 | - |
dc.contributor.AlternativeAuthor | 임상엽 | - |
dc.contributor.AlternativeAuthor | 도준형 | - |
dc.contributor.AlternativeAuthor | 조진만 | - |
dc.contributor.AlternativeAuthor | 김기석 | - |
dc.contributor.AlternativeAuthor | 배장완 | - |
dc.contributor.AlternativeAuthor | 정우영 | - |
dc.contributor.AlternativeAuthor | 연태진 | - |
dc.identifier.doi | 10.1186/1745-6215-14-398 | - |
dc.citation.journaltitle | Trials | - |
dc.language.rfc3066 | en | - |
dc.description.version | Peer Reviewed | - |
dc.rights.holder | Joo Myung Lee et al.; licensee BioMed Central Ltd. | - |
dc.date.updated | 2014-04-03T06:27:53Z | - |
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