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自贴式Stentys药物洗脱支架在左主干经皮冠状动脉介入治疗中的长期安全性和有效性:多中心LM-STENTYS注册研究的最终结果

Long-term safety and efficacy of self-apposing Stentys drug-eluting stent in left main stem percutaneous coronary intervention: final results of multicentre LM-STENTYS registry.

作者信息

Mielczarek Maksymilian J, Michalski Tomasz, Wańha Wojciech, Ciećwierz Dariusz, Smolka Grzegorz, Marcinkowska Marta, Chmielecki Michał, Tomasiewicz Brunon, Kubler Piotr, Kasprzak Michał, Chamera Marta, Gorol Jarosław, Bartuś Stanisław, Kubica Jacek, Reczuch Krzysztof, Hawranek Michał, Ochała Andrzej, Wojakowski Wojciech, Gruchała Marcin, Jaguszewski Miłosz

机构信息

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.

CLEVERHEART University Interventional Core Laboratories, Gdansk, Poland.

出版信息

Cardiol J. 2025;32(3):239-247. doi: 10.5603/cj.101925. Epub 2025 May 30.

DOI:10.5603/cj.101925
PMID:40444777
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12221320/
Abstract

BACKGROUND

Stentys drug-eluting stent (Stentys DES) was proposed to possess potential benefits over balloon-expandable platforms in large bifurcations, mainly distal left main stem (LMS). Several registries demonstrated favourable one-year clinical results of percutaneous coronary intervention (PCI) using Stentys DES for LMS disease. However, long-term follow- up data have been lacking hitherto.

METHODS

The study enrolled 175 consecutive patients who underwent PCI with Stentys DES for unprotected LMS and categorized them into acute- and chronic coronary syndrome (ACS/CCS). The primary endpoint was major adverse cardiac and cerebral events (MACCE) composed of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stroke assessed at five years. The secondary endpoints were stent thrombosis (ST), restenosis and target vessel revascularization (TVR).

RESULTS

Clinical follow-up at five years was completed for 124 out of 175 patients (70.9%), encompassing 85 with ACS and 39 with CCS. At five years, MACCE occurred in 55 out of 124 patients (44.4%). Although, there was a higher rate of MACCE (53% vs 28.2%, p = 0.018), MI (27.1% vs 2.6%, p = 0.016) and TLR (20% vs 2.6%, p = 0.036) in ACS vs. CCS patients, the rates of cardiac deaths were similar (27.1% vs. 25.6%, p = 0.77, respectively).

CONCLUSIONS

Herein, favourable long-term outcome of LMS PCI with Stentys DES in the CCS setting are shown. In the ACS setting, worse one-year outcome persisted at five years and was partially related to high rate of acute/subacute ST that might be optimized by immediate loading with potent antiplatelet drugs.

摘要

背景

Stentys药物洗脱支架(Stentys DES)被认为在大型分叉病变,主要是左主干远端(LMS)病变中,相对于球囊扩张平台具有潜在优势。多项注册研究表明,使用Stentys DES治疗LMS疾病的经皮冠状动脉介入治疗(PCI)具有良好的一年临床效果。然而,迄今为止一直缺乏长期随访数据。

方法

该研究纳入了175例连续接受Stentys DES治疗无保护LMS的PCI患者,并将他们分为急性和慢性冠状动脉综合征(ACS/CCS)。主要终点是五年时评估的主要不良心脑血管事件(MACCE),包括心源性死亡、心肌梗死(MI)、靶病变血运重建(TLR)和中风。次要终点是支架血栓形成(ST)、再狭窄和靶血管血运重建(TVR)。

结果

175例患者中有124例(70.9%)完成了五年临床随访,其中85例为ACS患者,39例为CCS患者。五年时,124例患者中有55例(44.4%)发生MACCE。尽管ACS患者的MACCE发生率(53%对28.2%,p = 0.018)、MI发生率(27.1%对2.6%,p = 0.016)和TLR发生率(20%对2.6%,p = 0.036)高于CCS患者,但心源性死亡率相似(分别为27.1%对25.6%,p = 0.77)。

结论

本文显示了在CCS情况下使用Stentys DES进行LMS PCI的良好长期结果。在ACS情况下,一年时的较差结果在五年时仍然存在,并且部分与急性/亚急性ST的高发生率有关,这可能通过立即使用强效抗血小板药物来优化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/24bb41edbabc/cardj-32-3-239f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/db547a6c93e4/cardj-32-3-239f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/4032c7bd4b78/cardj-32-3-239f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/f64f143fdfa5/cardj-32-3-239f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/24bb41edbabc/cardj-32-3-239f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/db547a6c93e4/cardj-32-3-239f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/4032c7bd4b78/cardj-32-3-239f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/f64f143fdfa5/cardj-32-3-239f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5424/12221320/24bb41edbabc/cardj-32-3-239f4.jpg

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