Science, Medicine, and the Anesthesiologist

An industry-sponsored randomized study of outcome of transcatheter aortic valve replacement (TAVR) versus surgical replacement (Edwards Lifesciences PARTNER trial; SAPIEN-3 valve) in patients with severe, symptomatic aortic stenosis at low surgical risk has previously reported lower rates of a first primary composite endpoint of death, stroke, or rehospitalization at 1 and 1 yr with TAVR. This report presents outcomes through 5 yr. A second primary endpoint included a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. A total of 1,000 patients were randomized to TAVR (N = 503) or surgery (N = 497). No significant difference was noted in the first primary outcome (Kaplan–Meier estimates, 22.8% TAVR vs. 27.2% surgery; difference, −4.3 percentage points; 95% CI, −9.9 to 1.3; P = 0.07). The win ratio for the second primary endpoint was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). Echocardiographic assessment of mean valve gradients was similar (12.8 ± 6.5 [SD] mmHg TAVR group vs.11.7 ± 5.6 mmHg surgery), as was the incidence of bioprosthetic valve failure (3.3% TAVR vs. 3.8% surgery).

Take home message: Five-year follow-up of patients with severe, symptomatic aortic stenosis at low surgical risk recruited to a large, randomized trial of TAVR versus surgery has reported no significant between-group difference in two primary composite outcomes.