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药物洗脱生物可吸收支架与药物洗脱金属支架在直接经皮冠状动脉介入治疗后后扩张的效果:TROFI II 血管造影和光学相干断层成像亚研究。

Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy.

机构信息

Department of Cardiology, Bern University Hospital, Bern, Switzerland.

Thorax Institute, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

出版信息

JACC Cardiovasc Interv. 2017 Sep 25;10(18):1867-1877. doi: 10.1016/j.jcin.2017.07.035.

DOI:10.1016/j.jcin.2017.07.035
PMID:28935079
Abstract

OBJECTIVES

This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES).

BACKGROUND

Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes.

METHODS

In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status.

RESULTS

Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm vs. 5.72 ± 1.77 mm; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm vs. 5.55 ± 1.77 mm; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72).

CONCLUSIONS

In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803).

摘要

目的

本研究旨在对比研究在直接经皮冠状动脉介入治疗(PCI)中应用依维莫司洗脱生物可吸收支架(BRS)与依维莫司洗脱金属支架(EES)时,后扩张对血管造影和血管内影像学参数的影响。

背景

有研究建议,对 BRS 进行常规后扩张可以改善术后血管造影和随后的器械相关临床结局。

方法

在 ABSORB STEMI TROFI II 试验中,191 例 ST 段抬高型心肌梗死患者被随机分为 BRS(n=95)或 EES(n=96)治疗组。通过光学相干断层扫描评估 6 个月时的最小管腔面积和愈合评分,并根据后扩张状态对 BRS 和 EES 治疗患者进行分层比较。

结果

48 例(50.5%)BRS 治疗病变和 25 例(25.5%)EES 治疗病变行 PCI 后扩张。两组间的基线特征和术后最小管腔直径无差异。在 BRS 组中,后扩张病变与 6 个月时较小的最小管腔面积(5.07±1.68mm 比 5.72±1.77mm;p=0.09)和明显较大的血管造影晚期管腔丢失(0.28±0.34mm 比 0.12±0.25mm;p=0.02)相关,而 EES 组无差异(5.46±2.18mm 比 5.55±1.77mm;p=0.85)。新生内膜愈合评分较低,且两组间无差异(BRS:1.55±2.61 比 1.92±2.17;p=0.48;EES:2.50±3.33 比 2.90±4.80;p=0.72)。

结论

在接受直接 PCI 的 ST 段抬高型心肌梗死患者中,对 BRS 或 EES 进行选择性后扩张并不能在随访中带来更大的管腔面积或改善动脉愈合。(ABSORB STEMI:TROFI II;NCT01986803)。

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