February 27, 2020

Five-Year PARTNER 2 Data Published Comparing TAVR Using Edwards Sapien XT Versus SAVR

February 27, 2020—The 5-year outcomes from the PARTNER 2 trial were published by Raj R. Makkar, MD, et al in The New England Journal of Medicine (NEJM; 2020;382:799–809).

The purpose of the trial was to determine the safety and effectiveness of the Sapien XT transcatheter aortic valve replacement (TAVR) and delivery systems (Edwards Lifesciences), which is intended for use in patients with symptomatic, calcific, severe aortic stenosis, as compared with surgical aortic valve replacement (SAVR).

The PARTNER 2 investigators concluded in NEJM, "Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with SAVR."

As summarized in NEJM, the investigators enrolled 2,032 intermediate-risk patients with severe symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or SAVR. Clinical, echocardiographic, and health-status outcomes were followed for 5 years.

The trial's primary endpoint was death from any cause or disabling stroke.

The investigators found that at 5 years there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group versus the surgery group (47.9% vs 43.4%; hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.95–1.25; P = .21). Results were similar for the transfemoral-access cohort (44.5% vs 42%, respectively; HR, 1.02; 95% CI, 0.87–1.20).

However, the investigators noted that the incidence of death or disabling stroke was higher after TAVR than after SAVR in the transthoracic-access cohort (59.3% vs 48.3%; HR, 1.32; 95% CI, 1.02–1.71).

Additionally, more patients in the TAVR group than in the SAVR group had at least mild paravalvular aortic regurgitation (33.3% vs 6.3%) at 5 years. Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs 25.2%), as were aortic valve reinterventions (3.2% vs 0.8%). Improvement in health status at 5 years was similar for TAVR and SAVR reported the investigators in NEJM.


March 2, 2020

Meta-Analysis Compares DES and CABG for Left Main Coronary Artery Disease

February 26, 2020

FDA's eSTAR Program Seeks to Promote Greater Efficiency and Consistency in the 510(k) Process