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新一代超小径药物洗脱支架与上一代较厚支架药物洗脱支架治疗冠状动脉疾病的比较。

Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease.

机构信息

New York University School of Medicine (S.B., F.F.).

Mt. Sinai Beth Israel Medical Center, New York, NY (B.T., N.P.).

出版信息

Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456.

Abstract

BACKGROUND

Contemporary second-generation drug-eluting stents (DES) have superior efficacy and safety in comparison with early-generation stents in patients undergoing percutaneous coronary intervention, in part, related to their thinner struts. Whether newer-generation ultrathin DES further improve clinical outcomes in comparison with older second-generation thicker strut DES is unknown.

METHODS

We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for randomized clinical trials that compared newer-generation ultrathin strut DES (defined as strut thickness <70 µm) versus thicker strut second-generation DES and reported clinical outcomes. The primary outcome was target lesion failure (composite of cardiovascular death, target vessel myocardial infarction or ischemia-driven target lesion revascularization) evaluated at 1-year follow-up. Tests for subgroup effects based on the ultrathin strut DES type and the comparator DES type were performed by using meta-regression analysis.

RESULTS

We identified 10 trials that randomly assigned 11 658 patients and evaluated 3 newer-generation ultrathin strut DES: Orsiro stent (60 μm), MiStent (64 μm), and BioMime (65 µm). In comparison with thicker strut second-generation DES, newer-generation ultrathin strut DES were associated with a 16% reduction in target lesion failure (relative risk, 0.84; 95% CI, 0.72-0.99) driven by less myocardial infarction (relative risk, 0.80; 95% CI, 0.65-0.99). Ultrathin strut DES were also associated with qualitatively lower rates of any stent thrombosis (relative risk, 0.72; 95% CI, 0.51-1.01). Tests for subgroup effects based on the ultrathin strut DES type ( P=0.58) and the comparator DES type ( P=0.98) were not significant, suggesting consistent outcomes across the 3 ultrathin strut DES and with the different DES comparators.

CONCLUSIONS

In patients undergoing percutaneous coronary intervention, newer-generation ultrathin strut DES further improve 1-year clinical outcomes in comparison with contemporary thicker strut second-generation DES.

摘要

背景

与早期支架相比,当代第二代药物洗脱支架(DES)在经皮冠状动脉介入治疗患者中具有更好的疗效和安全性,部分原因是其支架较薄。新一代超薄 DES 是否比旧的第二代厚支架 DES 进一步改善临床结局尚不清楚。

方法

我们在 PubMed、Embase 和 Cochrane 对照试验中心注册数据库中检索了比较新一代超薄支架(定义为支架厚度<70μm)与较厚第二代支架并报告临床结局的随机临床试验。主要结局是 1 年随访时的靶病变失败(心血管死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的复合终点)。通过使用 meta 回归分析,对基于超薄支架 DES 类型和比较 DES 类型的亚组效应进行了检验。

结果

我们确定了 10 项试验,共纳入 11658 例患者,评估了 3 种新一代超薄支架:Orsiro 支架(60μm)、MiStent(64μm)和 BioMime(65μm)。与较厚的第二代 DES 相比,新一代超薄支架与靶病变失败率降低 16%相关(相对风险,0.84;95%CI,0.72-0.99),这主要是由于心肌梗死减少(相对风险,0.80;95%CI,0.65-0.99)。超薄支架血栓形成的发生率也较低(相对风险,0.72;95%CI,0.51-1.01)。基于超薄支架类型( P=0.58)和比较 DES 类型( P=0.98)的亚组效应检验无统计学意义,提示 3 种超薄支架和不同 DES 比较之间的结果一致。

结论

在经皮冠状动脉介入治疗患者中,与当代较厚的第二代支架相比,新一代超薄支架可进一步改善 1 年临床结局。

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