Background: The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent,\r\nfeaturing a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus,\r\nvia controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding\r\ntissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss\r\nat 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting\r\nstents in a broader population of all-comers are limited. The present study offers an angiographic and clinical\r\ncomparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in\r\nthe treatment of patients with coronary artery disease.\r\nMethods/design: The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to\r\ndemonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity\r\nzotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective,\r\nrandom assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio),\r\nfor a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary\r\n12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial\r\ninfarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization\r\nand target vessel-related myocardial infarction).\r\nDiscussion: The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with\r\nthe Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary\r\nartery disease.
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