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

Joo Myung Lee, Sang Don Park, Sang Yeob Lim, Joon Hyung Doh, Jin Man Cho, Ki Seok Kim, Jang Whan Bae, Woo Young Chung, Tae Jin Youn

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.Trial registration: Clinicaltrials.gov NCT01826552.

Original languageEnglish
Article number398
JournalTrials
Volume14
Issue number1
DOIs
Publication statusPublished - 2013 Nov 20

Fingerprint

Sirolimus
Clinical Protocols
Stents
Coronary Artery Disease
Randomized Controlled Trials
zotarolimus
Polymers
Myocardial Infarction
Safety
Drug-Eluting Stents
Coronary Angiography
Population
Thrombosis

Keywords

  • Coronary heart disease
  • Drug-eluting stent
  • Orsiro hybrid stent
  • Zotarolimus-eluting stent

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / Lee, Joo Myung; Park, Sang Don; Lim, Sang Yeob; Doh, Joon Hyung; Cho, Jin Man; Kim, Ki Seok; Bae, Jang Whan; Chung, Woo Young; Youn, Tae Jin.

In: Trials, Vol. 14, No. 1, 398, 20.11.2013.

Research output: Contribution to journalArticle

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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.Trial registration: Clinicaltrials.gov NCT01826552.",
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AU - Park, Sang Don

AU - Lim, Sang Yeob

AU - Doh, Joon Hyung

AU - Cho, Jin Man

AU - Kim, Ki Seok

AU - Bae, Jang Whan

AU - Chung, Woo Young

AU - Youn, Tae Jin

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