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依维莫司洗脱型可吸收生物可降解血管支架重叠与非重叠的临床结局:来自多中心前瞻性RAI注册研究(ClinicalTrials.gov标识符:NCT02298413)的分析

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413).

作者信息

Tarantini Giuseppe, Mojoli Marco, Masiero Giulia, Cortese Bernardo, Loi Bruno, Varricchio Attilio, Gabrielli Gabriele, Durante Alessandro, Pasquetto Giampaolo, Calabrò Paolo, Gistri Roberto, Tumminello Gabriele, Misuraca Leonardo, Pisano Francesco, Ielasi Alfonso, Mazzarotto Pietro, Coscarelli Sebastian, Lucci Valerio, Moretti Luciano, Nicolino Annamaria, Colombo Alessandro, Olivari Zoran, Fineschi Massimo, Piraino Davide, Piatti Luigi, Canosi Umberto, Tellaroli Paola, Corrado Donatella, Rovera Chiara, Steffenino Giuseppe

机构信息

Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy.

Department of Interventional Cardiology, A.O. Fatebenefratelli, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2018 Jan 1;91(1):E1-E16. doi: 10.1002/ccd.27095. Epub 2017 May 13.

Abstract

OBJECTIVES

To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS.

BACKGROUND

Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent.

METHODS

We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry.

RESULTS

Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints.

CONCLUSIONS

Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.

摘要

目的

比较接受重叠式与非重叠式Absorb生物可吸收血管支架(BVS)治疗的患者的临床结局。

背景

关于支架重叠对Absorb BVS生物可吸收支架临床影响的数据有限。

方法

我们在多中心前瞻性RAI注册研究中比较了接受重叠或非重叠Absorb BVS治疗的患者的结局。

结果

在1505例连续接受Absorb BVS治疗的患者中,1384例符合本分析条件。其中,377例(27%)在重叠组,1007例(73%)在非重叠组。最常见的重叠构型是标记对标记型(48%),其次是标记重叠标记型(46%)和标记内标记型(6%)。重叠组患者多支血管病变的患病率更高,SYNTAX评分更高,且更频繁地需要使用血管内成像。在中位随访368天时,重叠组和非重叠组在器械相关复合终点(心源性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建)方面无差异(5.8%对4.1%,P = 0.20),在患者相关复合终点(任何死亡、任何心肌梗死、任何血运重建)方面也无差异(15.4%对12.5%,P = 0.18)。两组的心源性死亡(1.0%对1.3%,P = 0.54)、心肌梗死(4.5%对3.6%,P = 0.51)、靶血管血运重建(4.5%对3.6%,P = 0.51)和支架血栓形成(1.1%对1.5%,P = 1.00)也相当。根据所使用的重叠构型评估重叠人群的结局时,在器械或患者相关复合终点方面未观察到差异。

结论

尽管重叠亚组的血管造影复杂性较高,但在中期随访时,有或无BVS重叠患者的结局相当。©2017威利期刊公司。

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