冠状动脉血运重建中，生物可降解聚合物西罗莫司洗脱超微支架与持久性聚合物依维莫司洗脱支架的非选择性应用。
Unselected Use of Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Coronary Revascularization.
机构信息
Swiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Switzerland (K.Y., T.Z., C.Z., S.S., K.C.K., L.H., F.P., S.B., C.M., A.M., C.S., M.V., M.B., T.P., S.W., L.R.).
Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Switzerland (D.H.).
出版信息
Circ Cardiovasc Interv. 2018 Sep;11(9):e006741. doi: 10.1161/CIRCINTERVENTIONS.118.006741.
BACKGROUND
Biodegradable polymer sirolimus-eluting stents (BP-SESs) have been reported to be noninferior compared with durable polymer everolimus-eluting stents (DP-EES) in a randomized clinical trial. We sought to compare the efficacy and safety of an ultrathin strut BP-SES with a DP-EES in an all-comers population.
METHODS AND RESULTS
Among 7640 consecutive patients who underwent percutaneous coronary intervention between March 2011 and June 2015, 4638 patients were exclusively treated with BP-SES (N=1896; 3137 lesions) or DP-EES (N=2742; 4468 lesions). After propensity score matching within strata of clinical indications, the final study population consisted of 2902 matched patients (BP-SES 2406 lesions and DP-EES 2368 lesions). The primary device-oriented composite end point (DOCE) included cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1 year. BP-SES (6.9%) was noninferior to DP-EES (8.0%) with respect to device-oriented composite end point (hazard ratio [HR], 0.85; 95% CI, 0.65-1.11; P for noninferiority <0.001; P for superiority=0.24). No differences in cardiac death (BP-SES, 2.3% versus DP-EES, 3.0%; HR, 0.76; 95% CI, 0.49-1.20; P=0.25), myocardial infarction (BP-SES, 4.6% versus DP-EES, 4.6%; HR, 1.00; 95% CI, 0.71-1.40; P=0.99), or target lesion revascularization (BP-SES, 2.8% versus DP-EES, 2.5%; HR, 1.11; 95% CI, 0.71-1.74; P=0.65) were observed. The rate of periprocedural myocardial infarction was comparable between the 2 groups (2.1% versus 2.2%; HR, 0.97; 95% CI, 0.59-1.58; P=0.89). The rate of definite stent thrombosis was similarly low throughout 1 year (BP-SES, 0.8% versus DP-EES, 0.8%; HR, 1.00; 95% CI, 0.45-2.22; P=1.00).
CONCLUSIONS
In a consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, BP-SES was noninferior to DP-EES for device-oriented composite end point at 1 year.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02241291.
背景
生物可降解聚合物西罗莫司洗脱支架（BP-SES）与耐用聚合物依维莫司洗脱支架（DP-EES）相比，在一项随机临床试验中显示出非劣效性。我们旨在比较超小径聚合物 BP-SES 与 DP-EES 在所有患者人群中的疗效和安全性。
方法和结果
在 2011 年 3 月至 2015 年 6 月期间连续接受经皮冠状动脉介入治疗的 7640 例患者中，4638 例患者仅接受 BP-SES（N=1896；3137 处病变）或 DP-EES（N=2742；4468 处病变）治疗。在临床适应证分层内进行倾向评分匹配后，最终研究人群包括 2902 例匹配患者（BP-SES 2406 处病变和 DP-EES 2368 处病变）。主要的器械导向复合终点（DOCE）包括 1 年内的心脏死亡、靶血管心肌梗死和靶病变血运重建。BP-SES（6.9%）在器械导向复合终点方面非劣效于 DP-EES（8.0%）（风险比[HR]，0.85；95%置信区间，0.65-1.11；P<0.001；P=0.24 用于优效性）。心脏死亡（BP-SES，2.3% vs DP-EES，3.0%；HR，0.76；95%置信区间，0.49-1.20；P=0.25）、心肌梗死（BP-SES，4.6% vs DP-EES，4.6%；HR，1.00；95%置信区间，0.71-1.40；P=0.99）或靶病变血运重建（BP-SES，2.8% vs DP-EES，2.5%；HR，1.11；95%置信区间，0.71-1.74；P=0.65）方面无差异。两组间围手术期心肌梗死发生率相当（2.1% vs 2.2%；HR，0.97；95%置信区间，0.59-1.58；P=0.89）。1 年内确定的支架血栓形成率也相似较低（BP-SES，0.8% vs DP-EES，0.8%；HR，1.00；95%置信区间，0.45-2.22；P=1.00）。
结论
在反映常规临床实践的连续入选的经皮冠状动脉介入治疗人群中，BP-SES 在 1 年时的器械导向复合终点非劣效于 DP-EES。
临床试验注册
网址：https://www.clinicaltrials.gov 。唯一标识符：NCT02241291。
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