comparison of the angiographic result of the orsiro hybrid stent with resolute integrity stent

Conditions: Coronary Artery Disease; Coronary Heart Disease; Stable Angina; Unstable Angina; ST-segment Elevation Myocardial Infarction; Non-ST-segment Elevation Myocardial Infarction

Summary: the purpose of this multicenter, randomized, open label, parallel arm study whether the newest 3rd generation stent - orsiro hybrid sirolimus-eluting stent is noninferior to the newest 2nd generation stent - resolute integrity zotarolimus-eluting stent in terms of 9 months in-stent late lumen loss. 345 korean patients with a wide variety of coronary heart disease will be enrolled to this "all-comers" trial to give definite answer to the above hypothesis that is urgently needed.

the rate of restenosis after percutaneous coronary intervention (pci) has dramatically decreased since the introduction of drug-eluting stents (des). however, restenosis still remains a problem and some papers reported that the rate of restenosis can even go up to nearly 20% after the first-generation des implantation, depending on the complexity of target lesion. furthermore, there arises a concern about thrombogenic risk of these des at the expense of reduced restenosis. therefore, works aiming to reduce both restenosis and thrombosis are on-going, and there has been a rush of various second-generation des with "biocompatible but non-absorbable polymer" and third-generation des with "bioabsorbable polymer". recently, orsiro hybrid sirolimus-eluting stent (orsiro ses, biotronik ag, bulach, switzeland) has been developed. it has a unique hybrid combination of polymers coated on thin cobalt-chromium struts (60um). the biolute® active component is a bioabsorbable polymer matrix combined with an anti-proliferative drug, sirolimus, and elutes the drug in a controlled manner after implantation, degrades over time and leaves only the probio® coated stent behind in the long-term. the probio® passive coating encapsulates the stent and protects interaction between the metal stent and the surrounding tissue. although orsiro ses showed excellent results in terms of late lumen loss at 9 months in first-in-man single arm trial (bioflow-i trial), randomized controlled trials evaluating its efficacy and safety are limited to date. the orient trial will evaluate the angiographic and clinical outcomes of the innovative third-generation des, orsiro ses, compared with the latest second-generation des, resolute integrity zotarolimus-eluting stent (zes-i, medtronic cardiovascular, santa rosa, california, usa), for treatment of patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the orsiro hybrid des® or endeavor resolute integrity® stent. * he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, acute myocardial infarction, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ecg) consistent with ischemia) with a coronary artery or graft vessel lesion with \>50% stenosis by visual estimation or \>70% stenosis irrespective of the functional status. * target lesion(s) must be located in a coronary artery with estimated reference diameter of ≥ 2.5 mm and ≤ 5.0 mm. * target lesion(s) must be amenable for pci. exclusion criteria: * the patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, sirolimus, zotarolimus, cobalt chromium, contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. those with true anaphylaxis to prior contrast media, however, should not be enrolled.) * patients who cannot maintain aspirin, plavix from the study enrollment to study completion (during 1 year). * systemic (intravenous) sirolimus or zotarolimus use within 12 months. * female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. * history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions. * gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. * planned major non-cardiac surgery within the study period. * patients in cardiogenic shock * patients with symptomatic heart failure that preclude coronary angiography in supine position. * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Keywords: orsiro hybrid stent drug-eluting stent zotarolimus-eluting stent coronary heart disease cobalt chromium