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超薄型与传统第二代药物洗脱支架的长期随访:随机对照试验的系统评价和荟萃分析。

Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, New York, NY, USA.

Cardiovascular Research Foundation, New York, NY, USA.

出版信息

Eur Heart J. 2021 Jul 15;42(27):2643-2654. doi: 10.1093/eurheartj/ehab280.

Abstract

AIMS

Contemporary 2nd-generation thin-strut drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. A previous meta-analysis of 10 randomized controlled trials (RCTs) with 11 658 patients demonstrated a 16% reduction in the 1-year risk of target lesion failure (TLF) with ultrathin-strut DES compared with conventional 2nd-generation thin-strut DES. Whether this benefit is sustained longer term is not known, and newer trial data may inform these relative outcomes. We therefore sought to perform an updated systematic review and meta-analysis of RCTs comparing clinical outcomes with ultrathin-strut DES (≤70 µm strut thickness) with conventional 2nd-generation thin-strut DES.

METHODS AND RESULTS

We performed a random-effects meta-analysis of all RCTs comparing ultrathin-strut DES to conventional 2nd-generation thin-strut DES. The pre-specified primary endpoint was long-term TLF, a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included the components of TLF, stent thrombosis (ST), and all-cause death. There were 16 eligible trials in which 20 701 patients were randomized. The weighted mean follow-up duration was 2.5 years. Ultrathin-strut DES were associated with a 15% reduction in long-term TLF compared with conventional 2nd-generation thin-strut DES [relative risk (RR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.008] driven by a 25% reduction in CD-TLR (RR 0.75, 95% CI 0.62-0.92, P = 0.005). There were no significant differences between stent types in the risks of MI, ST, cardiac death, or all-cause mortality.

CONCLUSIONS

At a mean follow-up of 2.5 years, ultrathin-strut DES reduced the risk of TLF, driven by less CD-TLR compared with conventional 2nd-generation thin-strut DES, with similar risks of MI, ST, cardiac death, and all-cause mortality.

摘要

目的

当代第二代薄壁药物洗脱支架(DES)被认为是经皮冠状动脉介入治疗患者血运重建的标准治疗方法。此前对 10 项随机对照试验(RCT)的荟萃分析纳入了 11658 例患者,结果显示与传统第二代薄壁 DES 相比,超薄壁 DES 可使 1 年时的靶病变失败(TLF)风险降低 16%。但尚不清楚这种获益是否能长期持续,并且新的试验数据可能会影响这些相对结果。因此,我们旨在对比较超薄壁 DES(≤70μm 支架厚度)与传统第二代薄壁 DES 的 RCT 进行更新的系统评价和荟萃分析,以评估其临床结局。

方法和结果

我们对所有比较超薄壁 DES 与传统第二代薄壁 DES 的 RCT 进行了随机效应荟萃分析。预先设定的主要终点为长期 TLF,即心源性死亡、心肌梗死(MI)或临床驱动的靶病变血运重建(CD-TLR)的复合终点。次要终点包括 TLF 的组成部分、支架血栓形成(ST)和全因死亡。共有 16 项符合条件的试验纳入了 20701 例患者。加权平均随访时间为 2.5 年。与传统第二代薄壁 DES 相比,超薄壁 DES 可使长期 TLF 降低 15%[相对风险(RR)0.85,95%置信区间(CI)0.76-0.96,P=0.008],主要是由于 CD-TLR 降低了 25%(RR 0.75,95% CI 0.62-0.92,P=0.005)。两种支架类型在 MI、ST、心源性死亡或全因死亡率方面的风险没有显著差异。

结论

在平均 2.5 年的随访中,与传统第二代薄壁 DES 相比,超薄壁 DES 降低了 TLF 的风险,主要是由于 CD-TLR 降低,而 MI、ST、心源性死亡和全因死亡率的风险相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2a6/8282325/63d6e0057df6/ehab280f7.jpg

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