Transcatheter aortic-valve replacement for inoperable severe aortic stenosis
Raj R Makkar, Gregory P Fontana, Hasan Jilaihawi, Samir Kapadia, Augusto D Pichard, Pamela S Douglas, Vinod H Thourani, Vasilis C Babaliaros, John G Webb, Howard C Herrmann, Joseph E Bavaria, Susheel Kodali, David L Brown, Bruce Bowers, Todd M Dewey, Lars G Svensson, Murat Tuzcu, Jeffrey W Moses, Matthew R Williams, Robert J Siegel, Jodi J Akin, William N Anderson, Stuart Pocock, Craig R Smith, Martin B Leon, PARTNER Trial Investigators, M B Leon, C Smith, M Mack, D C Miller, J Moses, L Svensson, M Tuzcu, J Webb, N Cohen, G Dziem, W N Anderson, S Pocock, D Wang, W N Anderson, J Carrozza, A Wechsler, B Carabello, E Peterson, K Lee, S Bartus, J Petersen, P Douglas, D Cohen, M Reynolds, J Lasala, R Damiano, A Zajarias, H Maniar, K Striler, J Zoole, R Makkar, G Fontana, A Trento, S Kar, M Gheorghiu, A Doumanian, K Tolstrup, R Siegel, M Tuzcu, L Svensson, S Kapadia, E Roselli, R Bartow, C Gerace, L Rodriguez, W Stewart, R Grim, R Savage, M Leon, C Smith, J Moses, S Kodali, M Williams, M Hawkey, S Schnell, R Hahn, L Gillam, P Block, R Guyton, V Babaliaros, V Thourani, E Block, E Tequia, S Howell, F Mohr, G Schuler, T Walther, S Ott, J Rodes-Cabau, D Doyle, E Dumont, J Aube, I Palacios, G Vlahakes, A Agnihotri, I Inglessis, M Daher, A Jonri, D Holmes, T Sundt, C Rihal, K Greason, B Anderson, D Rolbiecki, H Michelena, M Sarano, K Andrew, M Mack, D Brown, B Bowers, T Dewey, C McKibben, A Kenady, D Gopal, T Feldman, J Alexander, M Salinger, D Seifert, C Focks, S Smart, J Marymount, C Davidson, P McCarthy, N Beohar, C Malaisrie, K Madden, M DeAngelis, I Mikati, P Teirstein, S Brewster, J Tyner, S Clarke, T Buchanan, E Anderson, C Miller, A Yeung, W Fearon, M Fischbein, M Speight, C McWard, D Liang, D Cohen, K Allen, A Grantham, J Hall, M Miller, J Webb, A Cheung, J Ye, S Lichtenstein, E Zwanenburg, E Horlick, C Feindel, W O'Neill, D Williams, A Heldman, A Medina, S Morales, M Bilsker, J Bavaria, H C Herrmann, W Szeto, L Roche, L Walsh, M Riesman, E Verrier, G Aldea, L Dean, R Letterer, C Otto, G Pichard, P Corso, S Boyce, L Satler, P Okubagzi, F Asch, S Goldstein, Raj R Makkar, Gregory P Fontana, Hasan Jilaihawi, Samir Kapadia, Augusto D Pichard, Pamela S Douglas, Vinod H Thourani, Vasilis C Babaliaros, John G Webb, Howard C Herrmann, Joseph E Bavaria, Susheel Kodali, David L Brown, Bruce Bowers, Todd M Dewey, Lars G Svensson, Murat Tuzcu, Jeffrey W Moses, Matthew R Williams, Robert J Siegel, Jodi J Akin, William N Anderson, Stuart Pocock, Craig R Smith, Martin B Leon, PARTNER Trial Investigators, M B Leon, C Smith, M Mack, D C Miller, J Moses, L Svensson, M Tuzcu, J Webb, N Cohen, G Dziem, W N Anderson, S Pocock, D Wang, W N Anderson, J Carrozza, A Wechsler, B Carabello, E Peterson, K Lee, S Bartus, J Petersen, P Douglas, D Cohen, M Reynolds, J Lasala, R Damiano, A Zajarias, H Maniar, K Striler, J Zoole, R Makkar, G Fontana, A Trento, S Kar, M Gheorghiu, A Doumanian, K Tolstrup, R Siegel, M Tuzcu, L Svensson, S Kapadia, E Roselli, R Bartow, C Gerace, L Rodriguez, W Stewart, R Grim, R Savage, M Leon, C Smith, J Moses, S Kodali, M Williams, M Hawkey, S Schnell, R Hahn, L Gillam, P Block, R Guyton, V Babaliaros, V Thourani, E Block, E Tequia, S Howell, F Mohr, G Schuler, T Walther, S Ott, J Rodes-Cabau, D Doyle, E Dumont, J Aube, I Palacios, G Vlahakes, A Agnihotri, I Inglessis, M Daher, A Jonri, D Holmes, T Sundt, C Rihal, K Greason, B Anderson, D Rolbiecki, H Michelena, M Sarano, K Andrew, M Mack, D Brown, B Bowers, T Dewey, C McKibben, A Kenady, D Gopal, T Feldman, J Alexander, M Salinger, D Seifert, C Focks, S Smart, J Marymount, C Davidson, P McCarthy, N Beohar, C Malaisrie, K Madden, M DeAngelis, I Mikati, P Teirstein, S Brewster, J Tyner, S Clarke, T Buchanan, E Anderson, C Miller, A Yeung, W Fearon, M Fischbein, M Speight, C McWard, D Liang, D Cohen, K Allen, A Grantham, J Hall, M Miller, J Webb, A Cheung, J Ye, S Lichtenstein, E Zwanenburg, E Horlick, C Feindel, W O'Neill, D Williams, A Heldman, A Medina, S Morales, M Bilsker, J Bavaria, H C Herrmann, W Szeto, L Roche, L Walsh, M Riesman, E Verrier, G Aldea, L Dean, R Letterer, C Otto, G Pichard, P Corso, S Boyce, L Satler, P Okubagzi, F Asch, S Goldstein
Abstract
Background: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.
Methods: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed.
Results: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation.
Conclusions: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Source: PubMed