Abstract
BackgroundThe 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/designThe 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).DiscussionThe 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 registrationClinicaltrials.gov NCT01826552
Highlights
The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix
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
The Orsiro SES has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial (BIOFLOW-I trial) [7], randomized controlled trials evaluating its efficacy and safety are limited to date
Summary
The first-generation of DESs, armed with sirolimus or paclitaxel, was shown to reduce in-stent neointimal hyperplasia, reduce rates of clinical restenosis and curtail the need for repeated PCI, compared with bare metal stents [17,18]. Second-generation devices were developed using breakthrough technology, such as thinner stent struts, permanent but biocompatible polymers to minimize inflammation or hypersensitivity reactions, and novel anti-proliferative agents. The ZES family and the everolimus-eluting stent (EES) are second-generation DES prototypes. They are fabricated with cobalt chromium alloy, which imparts superior radial strength and radiopacity. Even with the added polymer coating, the total strut thickness is only 71 μm (for a 3.0-mm stent), which is significantly thinner than comparators (ZES-R, 99 μm; EES, 95 μm). Abbreviation %DS: Percentage diameter stenosis; CAD: Coronary artery disease; CAG: Coronary angiography; DES: Drug-eluting stent; EES: Everolimus-eluting stent; F/U: Follow-up; MI: Myocardial infarction; MLD: Minimum lumen diameter; PCI: Percutaneous coronary intervention; QCA: Quantitative coronary angiography; SES: Sirolimus-eluting stent; TLR: Target lesion revascularization; TVR: Target vessel revascularization; ZES-I: Resolute integrity zotarolimus-eluting stent. SDP, SYL, JHD, JMC, KSK, JWB and WYC actively contributed to the study design, and all authors read and approved the final manuscript
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