The incidence of mortality or disabling stroke 5 years after intervention was comparable in patients at intermediate surgical risk who underwent transcatheter aortic valve replacement (TAVR) or surgery for severe, symptomatic aortic stenosis, according to study results published in The New England Journal of Medicine.
Despite the widespread use of TAVR as an alternative to surgical valve replacement in the treatment of aortic stenosis, few studies have compared the 2 approaches in terms of long-term clinical outcomes and the extended functionality of the bioprosthetic valves used.
In this multicenter randomized Placement of Aortic Transcatheter Valves (PARTNER) 2 cohort A trial (ClinicalTrials.gov identifier NCT01314313), 2032 patients with severe aortic stenosis who were considered to be at an intermediate surgical risk (mean age, 81.6 years; 54.5% men) were enrolled between December 2011 and November 2013. Study participants were followed for 5 years. Participants were randomly assigned 1:1 to undergo TAVR (n=1011; mean age, 81.5±6.7 years; 54.2% men) or open valve replacement surgery (n=1021; mean age, 81.7±6.7 years; 54.8% men). Participants were stratified for access route based on imaging studies: transfemoral (n=1550; 76.3%) or transthoracic (n=482; 23.7%).
All participants were assessed annually for 5 years for clinical and quality of life outcomes and underwent electrocardiogram following intervention. The study’s primary outcome was a composite of all-cause mortality or disabling stroke. Secondary outcomes included rates of reintervention, rehospitalization, and paravalvular regurgitation, hemodynamic parameters, and quality of life measures.
At the 5-year follow-up, the primary outcome was comparable in patients who had received TAVR vs surgery (47.9% vs 43.4%, respectively; hazard ratio [HR], 1.09; 95% CI, 0.95-1.25; P =.21) or for participants who had received TAVR vs surgery through transfemoral access (44.5% vs 42.0%, respectively; HR, 1.02; 95% CI, 0.87-1.20), but was higher in patients who underwent TAVR vs surgery through transthoracic access (59.3% vs 48.3%, respectively; HR, 1.32; 95% CI, 1.02-1.71).
A greater percentage of patients who underwent TAVR vs surgery experienced mild (or worse) paravalvular aortic regurgitation (33.3% vs 6.3%, respectively), aortic valve reinterventions (3.2% vs 0.8%, respectively; HR, 3.28; 95% CI, 1.32-8.13), and rehospitalizations (33.3% vs 25.2%, respectively; HR, 1.28; 95% CI, 1.07-1.53) at 5-year follow-up. Quality of life measures and health status improvement were similar between the groups across follow-up.
Study limitations include reduced clinical applicability due to lack of continued device use, uncertainty regarding extended device durability, and a lack of generalizability of the results to younger or lower risk patients.
“A key subgroup analysis showed that the outcomes of TAVR through transthoracic access, but not through transfemoral access, were inferior to those of open-heart surgery,” noted the study authors.
Disclosures: Supported by Edwards Lifesciences.
Makkar RR, Thourani VH, Mack MJ, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med . 2020;382(9):799-809. doi:10.1056/nejmoa1910555