PARTNER 3 Trial shows SAPIEN 3 valve superior to surgery in severe aortic stenosis

Edwards Lifesciences announced that the results of the randomized PARTNER 3 Trial demonstrated superiority for the SAPIEN 3 transcatheter aortic valve over outcomes with surgery. The trial, which compared treatment with the SAPIEN 3 valve to surgery in patients with severe symptomatic aortic stenosis (AS) at low risk of death from surgery, achieved superiority of its primary endpoint at one year.

The Kaplan–Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, ?6.6 percentage points). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of death or stroke and new-onset atrial fibrillation. TAVR also resulted in a shorter index hospitalization than surgery and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days. There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. The results of the trial will be presented at the American College of Cardiology's 68th Annual Scientific Session and have been published online in the New England Journal of Medicine.

See: "Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients" Michael J. Mack et al. NEJM March 17, 2019 DOI: 10.1056/NEJMoa1814052