经皮冠状动脉介入治疗患者中依维莫司洗脱支架与西罗莫司洗脱支架的随机比较：斯堪的纳维亚随机临床试验组织具有临床转归的 IV 期研究（SORT OUT IV）。
Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV).
机构信息
Department of Cardiology, Odense University Hospital, Denmark.
出版信息
Circulation. 2012 Mar 13;125(10):1246-55. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.
BACKGROUND
Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent.
METHODS AND RESULTS
The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88).
CONCLUSION
The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.
背景
在目前已发布的药物洗脱支架中，西罗莫司洗脱支架显示出最小的晚期管腔丢失，但与新一代依维莫司洗脱支架相比，其疗效和安全性尚未进行头对头比较。
方法和结果
斯堪的纳维亚随机临床试验中结果的第四阶段（SORT OUT IV）试验是一项随机、多中心、单盲、全纳入、双臂、非劣效性试验，比较了西罗莫司洗脱支架与依维莫司洗脱支架在冠状动脉疾病患者中的应用。主要终点是安全性（心源性死亡、心肌梗死、明确的支架血栓形成）和疗效（靶血管血运重建）参数的复合终点。非劣效性标准为风险差异 0.015。9 个月和 18 个月随访时进行意向治疗分析。共 1390 例患者被分配接受依维莫司洗脱支架治疗，1384 例患者接受西罗莫司洗脱支架治疗。在 9 个月的随访中，68 例（4.9%）接受依维莫司洗脱支架治疗的患者与 72 例（5.2%）接受西罗莫司洗脱支架治疗的患者发生主要终点事件（风险比，0.94；95%置信区间，0.67-1.31；P 非劣效性=0.01）。在 18 个月的随访中，这种差异仍然存在：99 例（7.2%）接受依维莫司洗脱支架治疗的患者与 105 例（7.6%）接受西罗莫司洗脱支架治疗的患者（风险比，0.94；95%置信区间，0.71-1.23）。在 9 个月的随访中，西罗莫司洗脱支架组的明确支架血栓形成发生率较高（2 例[0.1%]比 9 例[0.7%]；风险比，0.22；95%置信区间，0.05-1.02）。在 18 个月的随访中，这种差异仍然存在（3 例[0.2%]比 12 例[0.9%]；风险比，0.25；95%置信区间，0.07-0.88）。
结论
依维莫司洗脱支架被发现非劣效于西罗莫司洗脱支架。
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