Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk.
Circulation
; 139(24): 2714-2723, 2019 Jun 11.
Article
em En
| MEDLINE
| ID: mdl-30704298
ABSTRACT
BACKGROUND:
The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.METHODS:
Patients were enrolled at 3 Nordic centers and randomized 11 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.RESULTS:
Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm2 versus 1.2 cm2, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes.CONCLUSIONS:
These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. CLINICAL TRIAL REGISTRATION URL https//clinicaltrials.gov. Unique identifier NCT01057173.
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Circulation
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Dinamarca