TY - JOUR
T1 - 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)
T2 - Study protocol for a randomized controlled trial
AU - Lee, Joo Myung
AU - Park, Sang Don
AU - Lim, Sang Yup
AU - Doh, Joon Hyung
AU - Cho, Jin Man
AU - Kim, Ki Seok
AU - Bae, Jang Whan
AU - Chung, Woo Young
AU - Youn, Tae Jin
N1 - Funding Information:
This study is supported by a grant from Biotronik Korea. However, the sponsors have no part in the analysis or interpretation of the data. The authors thank Biomedproofreading.com for editing the manuscript. Our thanks are also extended to all members of the present study group for their ideas, suggestions, participation and general assistance.
Funding Information:
This trial is investigator-initiated, with grant support from the Biotronik Korea Co, Korea. Other than financial sponsorship, the company has no role in protocol development or the implementation, management, data collection and analysis of this study. The authors alone are responsible for the design and execution of the trial, related statistical analyses and all aspects of manuscript
PY - 2013/11/20
Y1 - 2013/11/20
N2 - 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.Trial registration: Clinicaltrials.gov NCT01826552.
AB - 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.Trial registration: Clinicaltrials.gov NCT01826552.
KW - Coronary heart disease
KW - Drug-eluting stent
KW - Orsiro hybrid stent
KW - Zotarolimus-eluting stent
UR - http://www.scopus.com/inward/record.url?scp=84887660175&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-14-398
DO - 10.1186/1745-6215-14-398
M3 - Article
C2 - 24257456
AN - SCOPUS:84887660175
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
IS - 1
M1 - 398
ER -