经皮冠状动脉介入治疗患者中可生物降解聚合物超薄支柱西罗莫司洗脱支架与可生物降解聚合物比伐卢定洗脱支架的随机对照比较：SORT OUT VII试验
Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial.
作者信息
Jensen Lisette Okkels, Thayssen Per, Maeng Michael, Ravkilde Jan, Krusell Lars Romer, Raungaard Bent, Junker Anders, Terkelsen Christian Juhl, Veien Karsten Tange, Villadsen Anton Boel, Kaltoft Anne, Tilsted Hans-Henrik, Hansen Knud Nørregaard, Aaroe Jens, Kristensen Steen Dalby, Hansen Henrik Steen, Jensen Svend Eggert, Madsen Morten, Bøtker Hans Erik, Berencsi Klára, Lassen Jens Flensted, Christiansen Evald Høj
机构信息
From the Department of Cardiology, Odense University Hospital, Denmark (L.O.J., P.T., A.J., K.T.V., K.N.H., H.S.H.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (M. Maeng, L.R.K., C.J.T., A.K., S.D.K., H.E.B., J.F.L., E.H.C.); Department of Cardiology, Aalborg University Hospital, Denmark (J.R., B.R., A.B.V., H.-H.T., J.A., S.E.J.); and Department of Clinical Epidemiology, Aarhus University, Denmark (M. Madsen, K.B.).
出版信息
Circ Cardiovasc Interv. 2016 Jul;9(7). doi: 10.1161/CIRCINTERVENTIONS.115.003610.
BACKGROUND
Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy.
METHODS AND RESULTS
The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05).
CONCLUSIONS
The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.
背景
具有可生物降解聚合物的冠状动脉药物洗脱支架旨在提高安全性和有效性。
方法与结果
斯堪的纳维亚临床结局随机试验组织（SORT OUT）VII试验——一项基于大规模注册研究的随机、多中心、单盲、双臂、非劣效性试验——在所有患者群体中比较了两种可生物降解聚合物药物洗脱支架：薄支柱钴铬西罗莫司洗脱Orsiro支架和不锈钢生物素洗脱Nobori支架。主要终点靶病变失败是指心脏死亡、心肌梗死（与靶病变无关）或1年内靶病变血运重建的复合情况，采用意向性分析（非劣效界值为3.0%）。基于丹麦注册研究进行临床驱动的事件检测。共有1261例患者被分配接受西罗莫司洗脱支架（1590个病变），1264例患者接受生物素洗脱支架（1588个病变）。1年时，西罗莫司洗脱组48例患者（3.8%）发生复合终点靶病变失败，生物素洗脱组58例患者（4.6%）发生（绝对风险差异，-0.78%[单侧95%置信区间上限，0.61%]；P<0.0001）。西罗莫司洗脱组5例（0.4%）发生明确支架内血栓形成，而生物素洗脱支架治疗患者为15例（1.2%）（率比，0.33；95%置信区间，0.12 - 0.92；P = 0.034），这主要归因于亚急性明确支架内血栓形成风险较低：0.1%对0.6%（率比，0.12；95%置信区间，0.02 - 1.00；P = 0.05）。
结论
在未选择的患者中，薄支柱西罗莫司洗脱Orsiro支架在1年时靶病变失败方面不劣于生物素洗脱Nobori支架。
Zotero 插件