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依维莫司与他克莫司洗脱生物可吸收支架治疗冠状动脉疾病的对比:一项匹配对照研究。

Everolimus- Versus Novolimus-Eluting Bioresorbable Scaffolds for the Treatment of Coronary Artery Disease: A Matched Comparison.

机构信息

University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany; Deutsches Herzzentrum München, Munich, Germany.

University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany.

出版信息

JACC Cardiovasc Interv. 2017 Mar 13;10(5):477-485. doi: 10.1016/j.jcin.2016.11.034. Epub 2017 Feb 15.

Abstract

OBJECTIVES

The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario.

BACKGROUND

eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients.

METHODS

Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis.

RESULTS

A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups.

CONCLUSIONS

The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed.

摘要

目的

本研究旨在比较依维莫司洗脱可吸收支架(eBRS)和诺维乐莫司洗脱可吸收支架(nBRS)在真实临床环境下经皮冠状动脉介入治疗患者的 1 年结果。

背景

eBRS 和 nBRS 已获准上市,并已被证明在经过精心选择的患者中用于冠状动脉支架置入是安全的。

方法

通过 2:1 倾向评分匹配,回顾性评估接受可吸收支架置入术的连续患者。12 个月时检查包括心源性死亡、靶血管心肌梗死和靶病变血运重建在内的靶病变失败,并检查其各个组成部分以及支架血栓形成。

结果

共 506 例患者可用于匹配。其中,212 例 eBRS 患者(平均年龄 62.9 岁)和 106 例 nBRS 患者(平均年龄 63.1 岁)在匹配后进行了分析。两组患者的基线特征和临床表现相似。eBRS 组中有 53.3%的患者为急性冠状动脉综合征,nBRS 组中有 48.1%(p=0.383)。病变特征也相似。预扩张(99.5% vs. 98.1%;p=0.218)和后扩张(84.4% vs. 86.8%;p=0.576)在匹配的 eBRS 和 nBRS 患者中比例相同。1 年靶病变失败(4.7% vs. 4.5%;p=0.851)、靶病变血运重建(2.6% vs. 3.5%;p=0.768)、心源性死亡(1.5% vs. 2.0%;p=0.752)和明确的支架血栓形成(2.0% vs. 1.0%;p=0.529)在 eBRS 和 nBRS 两组之间无显著差异。

结论

本研究表明,在常规实践中使用这两种类型的可吸收支架可获得相当的临床结果,但需要来自随机对照试验的进一步证据。

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