In a 7-year follow-up of the PARTNER 3 trial, lead study author Martin B. Leon, MD, of the Columbia University Irving Medical Center at the NewYork-Presbyterian Hospital, and colleagues reported that transcatheter aortic-valve replacement using the balloon-expandable SAPIEN 3 valve achieved outcomes comparable to surgical aortic-valve replacement in low-risk adult patients with severe, symptomatic aortic stenosis.
After a follow-up of 7 years, there were no statistically significant differences between the procedures in the composite rates of death, stroke, or rehospitalization related to the procedure, valve, or heart failure.
Among 1,000 patients (mean age, 73 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 1.9%) who were randomly assigned to undergo transcatheter aortic-valve replacement (TAVR) or the surgical procedure, the primary composite endpoint occurred in 34.6% of those in the TAVR group compared with 37.2% of those in the surgical group. The first primary endpoints of mortality (19.5% vs 16.8%), stroke (8.5% vs 8.1%), and rehospitalization (20.6% vs 23.5%) were similar between the TAVR and surgical procedure groups. Bioprosthetic valve failure rates were also similar (6.9% vs 7.3%), with mean aortic-valve gradients of 13.1 mmHg following TAVR and 12.1 mmHg postsurgery. Valve reintervention occurred in 6.7% of those in the TAVR group and 6.0% of those in the surgery group. At 7 years, 73.4% of TAVR recipients and 75.0% of surgical patients remained alive without valve failure.
New-onset atrial fibrillation occurred less frequently with TAVR compared with surgery (17.7% vs 43.5%), whereas left bundle branch block (21.1% vs 9.9%), valve thrombosis (2.8% vs 0.5%), and new pacemaker implantation (17.3% vs 12.8%) were more common. Mild or greater paravalvular regurgitation was more frequent after TAVR (17.7% vs 2.0%) but wasn't linked to increased mortality. Late myocardial infarction and revascularization were slightly higher with TAVR; however, the overall rates remained similar.
The researchers acknowledged that the study population excluded patients with complex anatomy or high procedural risk, limiting generalizability to all candidates for valve replacement. In addition, more surgical patients withdrew from follow-up, which could have influenced long-term mortality estimates despite vital-status verification.
The study was funded by Edwards Lifesciences, which participated in the trial design, data collection, and analysis. Several authors reported receiving research support or consulting fees from the sponsor.