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Question clinique
For intermediate-risk patients with aortic stenosis, how does transcatheter aortic valve replacement compare with surgery for long-term outcomes?
L’Essentiel
For patients with severe aortic stenosis and intermediate surgical risk, the 5-year outcomes of transcatheter aortic valve replacement (TAVR) are similar to those of surgical valve replacement, specifically with no significant difference in the composite outcome of death or disabling stroke. Although the TAVR patients in this study were more likely to have postsurgical paravalvular aortic regurgitation, this risk may be mitigated with the use of newer generation devices. 1b
Référence
Plan de l'etude: Randomized controlled trial (nonblinded)
Financement: Industry
Cadre: Inpatient (any location) with outpatient follow-up
Sommaire
This is the 5-year follow-up of the outcomes of the PARTNER 2 trial . In this study, intermediate-risk patients with symptomatic severe aortic stenosis were randomized to receive either TAVR (n = 1011) or surgical valve replacement (n = 1021). The 2 groups were similar at baseline with a mean age of 81 years; a predicted 30-day operative mortality of 5.8%; and similar incidences of coronary artery disease, previous coronary artery bypass graft surgery, and previous percutaneous coronary interventions. Data was available at 5 years for 91% of patients in the TAVR group and 81% in the surgery group. There was no significant difference between the 2 groups for the composite outcome of all-cause death or disabling stroke at 5 years (48% in TAVR group vs 43% in surgery group; P = 0.21). The TAVR group was more likely to be re-hospitalized (33.3% vs 25.2%; hazard ratio [HR] 1.28; 95% CI 1.07-1.53) and require re-intervention of the aortic valve (3.2% vs 0.8%; HR 3.28; 1.32-8.13), but less likely to have new-onset atrial fibrillation (15.8% vs 30.4%; HR 0.43; 0.35-0.53). The TAVR group had a higher incidence of paravalvular aortic regurgitation (33.3% vs 6.3%); however, this risk is reduced with the newer third-generation SAPIEN 3 valve device compared with the previous generation SAPIEN XT device used in this study. Both groups had improvement in functional status and quality of life at 5 years. .
Reviewer
Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine
Northwestern University
Chicago, IL