接受经导管主动脉瓣植入术的患者进行 PCI 治疗。

IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
New England Journal of Medicine Pub Date : 2024-12-12 Epub Date: 2024-08-31 DOI:10.1056/NEJMoa2401513
Jacob Lønborg, Reza Jabbari, Muhammad Sabbah, Karsten T Veien, Matti Niemelä, Phillip Freeman, Rickard Linder, Dan Ioanes, Christian J Terkelsen, Olli A Kajander, Sasha Koul, Mikko Savontaus, Pasi Karjalainen, Andrejs Erglis, Mikko Minkkinen, Rikke Sørensen, Hans-Henrik Tilsted, Lene Holmvang, Gintautas Bieliauskas, Julia Ellert, Jarkko Piuhola, Ashkan Eftekhari, Oskar Angerås, Andreas Rück, Evald H Christiansen, Troels Jørgensen, Burcu T Özbek, Charlotte Glinge, Lars Søndergaard, Ole De Backer, Thomas Engstrøm
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引用次数: 0

摘要

背景:对于接受经导管主动脉瓣植入术(TAVI)的稳定型冠状动脉疾病和重度主动脉瓣狭窄患者,经皮冠状动脉介入治疗(PCI)的益处仍不明确:在一项国际试验中,我们以1:1的比例随机分配患有严重症状性主动脉瓣狭窄且至少有一处冠状动脉狭窄(分流量储备在0.80以下或直径狭窄至少达90%)的患者接受PCI或保守治疗,所有患者同时接受TAVI。主要终点是重大心脏不良事件,定义为任何原因导致的死亡、心肌梗死或紧急血管重建的综合结果。安全性包括出血事件和手术并发症:共有 455 名患者接受了随机分组:227 名患者为 PCI 组,228 名患者为保守治疗组。患者的中位年龄为82岁(四分位间范围为78至85岁),胸外科医师协会-手术死亡率风险评分(评分范围为0至100%,分数越高,术后30天内死亡的风险越大)的中位数为3%(四分位间范围为2至4分)。中位随访 2 年(四分位间范围为 1 到 4)时,PCI 组有 60 名患者(26%)发生了重大心脏不良事件(主要终点),保守治疗组有 81 名患者(36%)发生了重大心脏不良事件(危险比为 0.71;95% 置信区间 [CI],0.51 到 0.99;P = 0.04)。PCI 组有 64 名患者(28%)发生出血事件,保守治疗组有 45 名患者(20%)发生出血事件(危险比为 1.51;95% 置信区间 [CI],1.03 至 2.22)。在PCI组中,7名患者(3%)出现了PCI手术相关并发症:结论:在接受 TAVI 的冠心病患者中,与保守治疗相比,PCI 与中位随访 2 年后因任何原因死亡、心肌梗死或紧急血运重建的复合风险更低相关。(由波士顿科学公司和丹麦心脏基金会资助;NOTION-3 ClinicalTrials.gov编号:NCT03058627)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.

Background: The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear.

Methods: In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed.

Results: A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications.

Conclusions: Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.).

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来源期刊
New England Journal of Medicine
New England Journal of Medicine 医学-医学:内科
CiteScore
145.40
自引率
0.60%
发文量
1839
审稿时长
1 months
期刊介绍: The New England Journal of Medicine (NEJM) stands as the foremost medical journal and website worldwide. With an impressive history spanning over two centuries, NEJM boasts a consistent publication of superb, peer-reviewed research and engaging clinical content. Our primary objective revolves around delivering high-caliber information and findings at the juncture of biomedical science and clinical practice. We strive to present this knowledge in formats that are not only comprehensible but also hold practical value, effectively influencing healthcare practices and ultimately enhancing patient outcomes.
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