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自膨式冠状动脉支架治疗急性 ST 段抬高型心肌梗死的前瞻性、观察性、意大利多中心注册研究:iPOSITION 注册研究。

A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry.

机构信息

Interventional Cardiology Unit, "SS. Annunziata" Hospital, Chieti, Italy.

Institute of Cardiology, "G. d'Annunzio" University, Chieti-Pescara, Italy.

出版信息

Cardiol J. 2021;28(6):842-848. doi: 10.5603/CJ.a2021.0045. Epub 2021 May 4.

DOI:10.5603/CJ.a2021.0045
PMID:33942280
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8747812/
Abstract

BACKGROUND

Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI.

METHODS

The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR).

RESULTS

The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%.

CONCLUSIONS

The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.

摘要

背景

ST 段抬高型心肌梗死(STEMI)患者行直接经皮冠状动脉介入治疗(pPCI)时,若血栓负荷重或儿茶酚胺诱导的血管收缩,可能会面临挑战。Xposition-S 支架旨在防止支架选择过小和最小化支架贴壁不良。我们评估了一种预装在新型球囊输送系统上的、用于治疗 STEMI 行 pPCI 患者的新型雷帕霉素洗脱、自膨式、镍钛诺支架的 1 年临床结局。

方法

iPOSITION 是一项前瞻性、多中心、上市后、观察性研究。主要终点为靶病变失败(TLF),定义为心脏死亡、靶血管再次心肌梗死(TV-MI)和临床驱动的靶病变血运重建(TLR)的复合终点。

结果

该研究纳入了来自意大利 7 个中心的 247 例 STEMI 患者。99.2%的患者实现了器械和手术成功,住院期间和 30 天随访期间无死亡、TV-MI、TLR 或支架血栓形成。1 年时,TLF 发生率为 2.6%,心脏死亡发生率为 1.7%,TV-MI 发生率为 0.4%,TLR 发生率为 0.4%。1 年支架血栓形成率为 0.4%。

结论

在 STEMI 行 pPCI 中使用 Xposition-S 自膨式支架是可行的,具有出色的术后结果和 1 年结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20f7/8747812/db84fe5d3ad8/cardj-28-6-842f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20f7/8747812/58727c93ae7f/cardj-28-6-842f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20f7/8747812/db84fe5d3ad8/cardj-28-6-842f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20f7/8747812/58727c93ae7f/cardj-28-6-842f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20f7/8747812/db84fe5d3ad8/cardj-28-6-842f2.jpg

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