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

Author:

Jørgensen Troels Højsgaard1ORCID,Thyregod Hans Gustav Hørsted1,Savontaus Mikko2,Willemen Yannick1ORCID,Bleie Øyvind3,Tang Mariann4ORCID,Niemela Matti5,Angerås Oskar6,Gudmundsdóttir Ingibjörg J7,Sartipy Ulrik8,Dagnegaard Hanna1,Laine Mika9ORCID,Rück Andreas8,Piuhola Jarkko5,Petursson Petur6,Christiansen Evald H4,Malmberg Markus2ORCID,Olsen Peter Skov1,Haaverstad Rune3ORCID,Sondergaard Lars10,De Backer Ole1ORCID, ,Jørgensen Troels Højsgaard,De Backer Ole,Søndergaard Lars,Dagnegaard Hanna,Olsen Peter Skov,Bleie Øyvind,Haarverstad Rune,Savontaus Mikko,Malmberg Markus,Christiansen Evald Høj,Tang Mariann,Niemelä Matti,Ahvenvaara Tuomas,Guðmundsdóttir Ingibjörg,Myrdal Gunnar,Angerås Oskar,Petursson Petur,Laine Mika,Vähäsilta Tommi,Rück Andreas,Sartipy Ulrik

Affiliation:

1. Rigshospitalet, Copenhagen University Hospital , Inge Lehmanns Vej 7, 2100 Copenhagen , Denmark

2. Department of Cardiology and Cardiothoracic Surgery, Turku University Hospital , Turku , Finland

3. Department of Cardiology and Cardiothoracic Surgery, Haukeland University Hospital , Bergen , Norway

4. Skejby, Aarhus University Hospital , Aarhus , Denmark

5. Department of Cardiology, Medical Research Center, Oulu University Hospital , Oulu , Finland

6. Department of Cardiology, Sahlgrenska University Hospital , Göteborg , Sweden

7. Department of Cardiology, Landspitali , Reykjavík , Iceland

8. Department of Cardiology and Cardiothoracic Surgery, Karolinska University Hospital , Stockholm , Sweden

9. Department of Cardiology, Helsinki University Central Hospital , Helsinki , Finland

10. Abbott Structural Heart , Santa Clara, CA , USA

Abstract

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.

Funder

Abbott

Boston Scientific

Edwards Lifesciences

Publisher

Oxford University Press (OUP)

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