Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.
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Makkar Raj R, Thourani Vinod H, Mack Michael J, Kodali Susheel K, Kapadia Samir, Webb John G, Yoon Sung-Han, Trento Alfredo, Svensson Lars G, Herrmann Howard C, Szeto Wilson Y, Miller D Craig, Satler Lowell, Cohen David J, Dewey Todd M, Babaliaros Vasilis, Williams Mathew R, Kereiakes Dean J, Zajarias Alan, Greason Kevin L, Whisenant Brian K, Hodson Robert W, Brown David L, Fearon William F, Russo Mark J, Pibarot Philippe, Hahn Rebecca T, Jaber Wael A, Rogers Erin, Xu Ke, Wheeler Jaime, Alu Maria C, Smith Craig R, Leon Martin B, PARTNER 2 Investigators
Аннотация
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.).