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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引用次数: 0
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).
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.