Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial.

IF 37.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal Pub Date : 2024-10-05 DOI:10.1093/eurheartj/ehae331

Troels Højsgaard Jørgensen, Hans Gustav Hørsted Thyregod, Mikko Savontaus, Yannick Willemen, Øyvind Bleie, Mariann Tang, Matti Niemela, Oskar Angerås, Ingibjörg J Gudmundsdóttir, Ulrik Sartipy, Hanna Dagnegaard, Mika Laine, Andreas Rück, Jarkko Piuhola, Petur Petursson, Evald H Christiansen, Markus Malmberg, Peter Skov Olsen, Rune Haaverstad, Lars Sondergaard, Ole De Backer

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Abstract

Background and aims: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS.

Methods: The Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months.

Results: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), -2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7-2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5-2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8-18.5) treated with TAVI or surgery, respectively (P for interaction = .1).

Conclusions: Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Trial registration number: ClinicalTrials.gov NCT02825134.

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低风险三尖瓣或双尖瓣主动脉瓣狭窄的经导管主动脉瓣植入术：NOTION-2 试验。

背景和目的：经导管主动脉瓣植入术（TAVI）已成为治疗老年重症主动脉瓣狭窄（AS）患者的首选。本研究旨在比较经导管主动脉瓣植入术和手术治疗年龄在 75 岁以下的低风险患者，包括三尖瓣和双尖瓣主动脉瓣狭窄患者：NOTION-2试验招募了年龄小于75岁、有严重症状的低危AS患者，并以1:1的比例随机分配了TAVI或手术。主要终点是12个月内的全因死亡率、中风或再次住院（与手术、瓣膜或心衰有关）的综合结果：共有370名患者入选，平均年龄为71.1岁，胸外科医师协会风险评分中位数为1.1%。共有100名患者患有双尖瓣强直性脊柱炎。TAVI组主要终点的1年发生率为10.2%，手术组为7.1%（绝对风险差异为3.1%；95%置信区间[CI]为-2.7%至8.8%；危险比（HR）为1.4，95% CI为0.7至2.9；P=0.3）。与手术相比，TAVI 患者发生大出血和新发心房颤动的风险较低，而发生非致残性中风、永久性起搏器植入和中度或更严重的瓣膜旁反流的风险较高。接受TAVI或手术治疗的三尖瓣强直性脊柱炎患者的主要复合终点风险分别为8.7%和8.3%（HR 1.0，95% CI：0.5至2.3），双尖瓣强直性脊柱炎患者的主要复合终点风险分别为14.3%和3.9%（HR 3.8，95% CI：0.8至18.5）（交互作用P=0.1）：结论：在年龄小于75岁、有严重症状的低危AS患者中，TAVI和手术治疗一年后死亡、中风或再次住院的复合死亡率相似。对于年轻的双尖瓣 AS 患者，TAVI 的效果值得警惕，并应进一步研究。(NOTION-2，ClinicalTrials.gov，NCT02825134）。

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来源期刊

European Heart Journal 医学-心血管系统

CiteScore

39.30

自引率

6.90%

发文量

3942

审稿时长

1 months

期刊介绍： The European Heart Journal is a renowned international journal that focuses on cardiovascular medicine. It is published weekly and is the official journal of the European Society of Cardiology. This peer-reviewed journal is committed to publishing high-quality clinical and scientific material pertaining to all aspects of cardiovascular medicine. It covers a diverse range of topics including research findings, technical evaluations, and reviews. Moreover, the journal serves as a platform for the exchange of information and discussions on various aspects of cardiovascular medicine, including educational matters. In addition to original papers on cardiovascular medicine and surgery, the European Heart Journal also presents reviews, clinical perspectives, ESC Guidelines, and editorial articles that highlight recent advancements in cardiology. Additionally, the journal actively encourages readers to share their thoughts and opinions through correspondence.