Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement
Raj Makkar, Vinod H. Thourani, Michael J. Mack, Susheel Kodali, Samir Kapadia, John G. Webb, Sung‐Han Yoon, Alfredo Trento, Lars G. Svensson, Howard C. Herrmann, Wilson Y. Szeto, D. Craig Miller, Lowell F. Satler, David J. Cohen, Todd Dewey, Vasilis Babaliaros, Mathew Williams, Dean J. Kereiakes, Alan Zajarías, Kevin L. Greason, Brian Whisenant, Robert W. Hodson, David L. Brown, William F. Fearon, Mark J. Russo, Philippe Pîbarot, Rebecca T. Hahn, Wael A. Jaber, Erin Rogers, Ke Xu, Jaime Wheeler, Maria Alu, Craig R. Smith, Martin B. Leon
Abstract
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 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 surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). 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 surgery. CONCLUSIONS: 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 surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).