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

Autor:	Jørgensen TH; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark., Thyregod HGH; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark., Savontaus M; Department of Cardiology and Cardiothoracic Surgery, Turku University Hospital, Turku, Finland., Willemen Y; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark., Bleie Ø; Department of Cardiology and Cardiothoracic Surgery, Haukeland University Hospital, Bergen, Norway., Tang M; Skejby, Aarhus University Hospital, Aarhus, Denmark., Niemela M; Department of Cardiology, Medical Research Center, Oulu University Hospital, Oulu, Finland., Angerås O; Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden., Gudmundsdóttir IJ; Department of Cardiology, Landspitali, Reykjavík, Iceland., Sartipy U; Department of Cardiology and Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden., Dagnegaard H; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark., Laine M; Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland., Rück A; Department of Cardiology and Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden., Piuhola J; Department of Cardiology, Medical Research Center, Oulu University Hospital, Oulu, Finland., Petursson P; Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden., Christiansen EH; Skejby, Aarhus University Hospital, Aarhus, Denmark., Malmberg M; Department of Cardiology and Cardiothoracic Surgery, Turku University Hospital, Turku, Finland., Olsen PS; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark., Haaverstad R; Department of Cardiology and Cardiothoracic Surgery, Haukeland University Hospital, Bergen, Norway., Sondergaard L; Abbott Structural Heart, Santa Clara, CA, USA., De Backer O; Rigshospitalet, Copenhagen University Hospital, Inge Lehmanns Vej 7, 2100 Copenhagen, Denmark.
Jazyk:	angličtina
Zdroj:	European heart journal [Eur Heart J] 2024 Oct 05; Vol. 45 (37), pp. 3804-3814.
DOI:	10.1093/eurheartj/ehae331
Abstrakt:	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. (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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