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

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.

Figures

Figure 1
Figure 1
ORIENT trial algorithm. ACC, American College of Cardiology; AHA, American Heart Association; CAG, coronary angiography; DES, drug-eluting stent; ESC, European Society of Cardiology; EACTS, European Association for Cardio-Thoracic Surgery; F/U, follow-up; QCA, quantitative coronary angiography; SCAI, The Society for Cardiovascular Angiography and Interventions; SES, sirolimus-eluting stent; ZES, zotarolimus-eluting stent.

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Source: PubMed

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