与使用永久性聚合物的西罗莫司洗脱支架相比，使用生物可降解聚合物的依维莫司洗脱支架治疗分叉病变的结果。
The outcome of bifurcation lesion stenting using a biolimus-eluting stent with a bio-degradable polymer compared to a sirolimus-eluting stent with a durable polymer.
机构信息
Department of Interventional Cardiology, Erasmus MC, Rotterdam, The Netherlands.
出版信息
EuroIntervention. 2011 Mar;6(8):928-35. doi: 10.4244/EIJV6I8A162.
AIMS
This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer.
METHODS AND RESULTS
The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.8% vs. SES 16.3%, p=0.31). Patients treated with BES had comparable rates of cardiac death (BES 2.7% vs. SES 2.9%, p=1.00), numerically higher rates of myocardial infarction (BES 8.9% vs. SES 5.4%, p=0.17), and significantly lower rates of clinically indicated target vessel revascularisation (4.3% vs. 11.3%, p=0.004) when compared to those treated with SES. The rate of stent thrombosis at 12-months was 4.3% and 3.8% for BES and SES, respectively (p=0.82).
CONCLUSIONS
In the treatment of BL the use of BES lead to superior efficacy and comparable safety compared to SES.
目的
本研究旨在探讨使用具有生物可降解聚合物的雷帕霉素洗脱支架（BES）和具有持久聚合物的西罗莫司洗脱支架（SES）治疗分叉病变（BL）患者的临床结局差异。
方法和结果
在多中心、随机 LEADERS 试验中，共纳入 497 例（BES 258 例，SES 239 例）接受≥1 个 BL 治疗（共 534 个 BL）的患者，评估了临床结局。在 12 个月随访时，主要终点 MACE（心脏死亡、心肌梗死和临床指征靶血管血运重建的复合）无显著差异（BES 为 12.8%，SES 为 16.3%，p=0.31）。BES 治疗组的心脏死亡发生率（BES 为 2.7%，SES 为 2.9%，p=1.00）、心肌梗死发生率（BES 为 8.9%，SES 为 5.4%，p=0.17）与 SES 治疗组相比具有可比性，而临床指征靶血管血运重建发生率（BES 为 4.3%，SES 为 11.3%，p=0.004）显著降低。12 个月时支架血栓形成的发生率分别为 BES 组 4.3%和 SES 组 3.8%（p=0.82）。
结论
在 BL 的治疗中，与 SES 相比，BES 的使用可带来更好的疗效和相似的安全性。
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