冠状动脉疾病患者中三种不同聚合物涂层雷帕霉素洗脱支架的十年临床结果研究。
Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease.
机构信息
Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.).
German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.).
出版信息
Circulation. 2019 Jan 15;139(3):325-333. doi: 10.1161/CIRCULATIONAHA.118.038065.
BACKGROUND
New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up.
METHODS
Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients.
RESULTS
The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES.
CONCLUSIONS
In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.
背景
与早期一代药物洗脱支架相比，新一代药物洗脱支架具有改善晚期结果的潜力。然而，这些设备的长期扩展结果评估缺乏，特别是关于生物可降解聚合物或永久性聚合物的新一代药物洗脱支架之间的比较。本研究的目的是比较生物可降解聚合物载西罗莫司洗脱支架（BP-SES； YukonChoicePC）与永久性聚合物载依维莫司洗脱支架（PP-EES； Xience）与早期一代永久性聚合物载西罗莫司洗脱支架（PP-SES； Cypher）在 10 年随访时的疗效和安全性。
方法
共有 2603 名患者被随机分配接受 BP-SES（n=1299）、PP-EES（n=652）或 PP-SES（n=652）治疗。本分析的主要终点是主要不良心脏事件，即死亡、心肌梗死或靶病变血运重建的复合终点。主要次要终点为确定/可能的支架血栓形成。在研究患者中，有 83%可获得 10 年随访。
结果
10 年时主要不良心脏事件的发生率（BP-SES 47.7%比 PP-EES 46.0%比 PP-SES 54.9%，P=0.003）和死亡率（BP-SES 31.8%比 PP-EES 30.3%比 PP-SES 37.2%，P=0.02）在各组之间不同。各组之间确定/可能的支架血栓形成无显著差异（BP-SES 1.8%比 PP-EES 2.5%比 PP-SES 3.7%，P=0.09）。确定的支架血栓形成在各组之间有显著差异（BP-SES 1.1%比 PP-EES 0.8%比 PP-SES 2.4%，P=0.03）。BP-SES 与 PP-EES 之间无显著差异。
结论
在这项独特的长期结果分析中，BP-SES 和 PP-EES 在 10 年内显示出相似的临床结果。PP-SES 的主要不良心脏事件和确定的支架血栓形成发生率较高。
Zotero 插件