无聚合物涂层 Amphilimus 洗脱支架与生物可降解聚合物涂层 Biolimus 洗脱支架在伴或不伴糖尿病患者中的应用。
Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus.
机构信息
San Raffaele Scientific Institute, Milan, Italy.
San Raffaele Scientific Institute, Milan, Italy.
出版信息
Int J Cardiol. 2017 Oct 15;245:69-76. doi: 10.1016/j.ijcard.2017.06.028.
OBJECTIVES
This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention.
BACKGROUND
The PF-AES has shown promising preliminary results in patients with DM.
METHODS
Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR).
RESULTS
After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; P=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; P=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; P=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; P=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005).
CONCLUSIONS
This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.
目的
本研究旨在比较聚合物自由型艾米利缪斯洗脱支架（PF-AES）与生物可降解聚合物型比莫司洗脱支架（BD-BES）在接受经皮冠状动脉介入治疗的“所有患者”糖尿病（DM）和非 DM 患者中的临床结局。
背景
PF-AES 在 DM 患者中显示出有前景的初步结果。
方法
使用来自 2 个多中心国家注册中心（ASTUTE 和 INSPIRE-1）的数据，对 1776 名患者进行分层，分为非 DM 和 DM 患者。在每组中进行了双重 1:1 倾向评分匹配分析（PF-AES 与 BD-BES），以调整临床和程序特征。主要支架疗效和支架安全性终点为 1 年靶病变血运重建（TLR）和靶病变失败（TLF，由心源性死亡、靶血管心肌梗死和任何 TLR 组成）。
结果
经过倾向评分匹配后，850 名患者被分为非 DM 组（425 名 PF-AES/425 名 BD-BES）和 480 名 DM 患者（240 名 PF-AES/240 名 BD-BES）。非 DM 患者中，PF-AES 和 BD-BES 之间的 TLF（20 例/425 例[5%]与 24 例/425 例[6%]；P=0.527）和 TLR（9 例/425 例[2%]与 18 例/425 例[4%]；P=0.079）相似。在 DM 患者中，PF-AES 的 TLF（12 例/240 例[5%]与 31 例/240 例[13%]；P=0.002）和 TLR（9 例/240 例[4%]与 21 例/240 例[9%]；P=0.019）明显低于 BD-BES。多变量分析表明，非 DM 患者中 TLF 的最强预测因素为慢性肾脏病（OR 4.24，95%CI：2.07-8.70，p<0.001）和 DM 患者的支架类型（OR 2.76，1.36-5.56，p=0.005）。
结论
这项匹配队列研究表明，PF-AES 在 DM 患者中的安全性和疗效优于 BD-BES。
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