经皮冠状动脉介入治疗患者中生物可降解聚合物西罗莫司洗脱支架与耐久性聚合物依维莫司洗脱支架的比较：来自 5 项随机试验的个体患者数据的荟萃分析。
Biodegradable polymer sirolimus-eluting stents vs durable polymer everolimus-eluting stents in patients undergoing percutaneous coronary intervention: A meta-analysis of individual patient data from 5 randomized trials.
机构信息
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
出版信息
Am Heart J. 2021 May;235:140-148. doi: 10.1016/j.ahj.2021.02.009. Epub 2021 Feb 17.
BACKGROUND
Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI).
METHODS
We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model.
RESULTS
At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P = .73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P = .061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P = .61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events.
CONCLUSIONS
In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI.
STUDY REGISTRATION
PROSPERO registry (CRD42018109098).
背景
最新一代药物洗脱支架将可生物降解聚合物与超薄支架平台相结合，以最大程度地减少血管损伤和炎症反应。随机对照试验的证据表明，支架设计的差异会转化为临床结果的差异。本研究旨在评估与薄壁、耐用聚合物依维莫司洗脱支架（DP EES）相比，超薄支架、可生物降解聚合物西罗莫司洗脱支架（BP SES）在接受经皮冠状动脉介入治疗（PCI）的患者中的安全性和疗效。
方法
我们汇总了 5 项随机试验（NCT01356888、NCT01939249、NCT02389946、NCT01443104、NCT02579031）的个体参与者数据，共纳入 5780 例患者，并使用混合效应 Cox 回归模型进行了一阶荟萃分析。
结果
中位随访时间为 739 天（四分位距 365-1806 天），BP SES 和 DP EES 治疗的患者中，靶病变失败分别为 337 例（10.3%）和 304 例（12.2%）（HR 0.86，95%CI 0.71-1.06，P=0.16）。BP SES 和 DP EES 在心源性死亡方面无显著差异（111 例[3.4%]vs 102 例[4.1%]；HR 1.05，95%CI 0.80-1.37，P=0.73）、靶血管心肌梗死（136 例[4.1%]vs 126 例[5.0%]；HR 0.79，95%CI 0.62-1.01，P=0.061）和临床驱动的靶病变血运重建（163 例[5.0%]vs 147 例[5.9%]；HR 0.94，95%CI 0.75-1.18，P=0.61）。主要亚组分析结果一致。在里程碑分析中，治疗效果与事件发生时间之间没有显著的交互作用。
结论
在这项 5 项随机对照试验的患者水平荟萃分析中，BP SES 与 DP EES 相比，在接受 PCI 的患者中靶病变失败的风险相似。
研究注册
PROSPERO 注册（CRD42018109098）。
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