Five-year outcomes of transcatheter or surgical aortic-valve replacement

TY - JOUR

T1 - Five-year outcomes of transcatheter or surgical aortic-valve replacement

AU - Makkar, R. R.

AU - Thourani, V. H.

AU - Mack, M. J.

AU - Kodali, S. K.

AU - Kapadia, S.

AU - Webb, J. G.

AU - Yoon, S. H.

AU - Trento, A.

AU - Svensson, L. G.

AU - Herrmann, H. C.

AU - Szeto, W. Y.

AU - Miller, D. C.

AU - Satler, L.

AU - Cohen, D. J.

AU - Dewey, T. M.

AU - Babaliaros, V.

AU - Williams, M. R.

AU - Kereiakes, D. J.

AU - Zajarias, A.

AU - Greason, K. L.

AU - Whisenant, B. K.

AU - Hodson, R. W.

AU - Brown, D. L.

AU - Fearon, W. F.

AU - Russo, M. J.

AU - Pibarot, P.

AU - Hahn, R. T.

AU - Jaber, W. A.

AU - Rogers, E.

AU - Xu, K.

AU - Wheeler, J.

AU - Alu, M. C.

AU - Smith, C. R.

AU - Leon, M. B.

AU - PARTNER 2 Investigators, 2 Investigators

N1 - Publisher Copyright: Copyright © 2020 Massachusetts Medical Society.

PY - 2020/2/27

Y1 - 2020/2/27

N2 - Background: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aorticvalve 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 healthstatus 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.

AB - Background: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aorticvalve 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 healthstatus 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.

UR - https://www.scopus.com/pages/publications/85078688872

U2 - 10.1056/NEJMoa1910555

DO - 10.1056/NEJMoa1910555

M3 - Article

C2 - 31995682

SN - 0028-4793

VL - 382

SP - 799

EP - 809

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 9

ER -