Transcatheter versus surgical aortic-valve replacement in high-risk patients
Craig R Smith, Martin B Leon, Michael J Mack, D Craig Miller, Jeffrey W Moses, Lars G Svensson, E Murat Tuzcu, John G Webb, Gregory P Fontana, Raj R Makkar, Mathew Williams, Todd Dewey, Samir Kapadia, Vasilis Babaliaros, Vinod H Thourani, Paul Corso, Augusto D Pichard, Joseph E Bavaria, Howard C Herrmann, Jodi J Akin, William N Anderson, Duolao Wang, Stuart J Pocock, PARTNER Trial Investigators, M B Leon, C Smith, M Mack, D C Miller, J Moses, L Svensson, M Tuzcu, J Webb, Jodi J Akin, Karen Foley, G Dziem, 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, B R Lindman, L Cohn, A Eisenhauer, F Welt, M Davidson, T Charleson, W Gross, R Makkar, G Fontana, A Trento, S Kar, M Gheorghiu, A Doumanian, J Stegic, K Tolstrup, R Siegel, M Tuzcu, L Svensson, S Kapadia, E Roselli, R Bartow, C Gerace, L Rodriguez, W Stewart, R Grim, R Savage, A Alfirevic, L Wallace, M Leon, C Smith, J Moses, S Kodali, M Williams, M Hawkey, S Schnell, R Hahn, L Gillam, S Chiu Wong, K Krieger, G Bergman, A Salemi, D Reynolds, R B Devereux, P Block, R Guyton, V Babaliaros, V Thourani, E Tequia, F Carter, S Lerakis, R Martin, S Howell, B Whisenant, K Jones, S Clayson, J Revenaugh, B Miller, J Flores, J Rodes-Cabau, D Doyle, Dumont, R Delarochelliere, J Aube, F Mohr, G Schuler, T Walther, S Ott, I Palacios, G Vlahakes, A Agnihotri, I Inglessis, M Daher, J Passeri, D Holmes, T Sundt, C Rihal, K Greason, B Anderson, D Rolbiecki, H Michelena, M Sarano, K Andrew, T Dewey, D Brown, B Bowers, M Mack, W Brinkman, C McKibben, A Kenady, J Foreman, K Roper, D Gopal, J Horswell, L Michelsen, 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, S Ramee, G Parrino, T Collins, M Bates, B Hirstius, L Bienvenu, P Teirstein, S Brewster, J Tyner, C Stinis, M Price, S Clarke, T Buchanan, E Anderson, D C Miller, A Yeung, W Fearon, M Fischbein, M Speight, C McWard, D Liang, D Cohen, K Allen, J A Grantham, M Borkon, A Chhatriwalla, J Hall, M Miller, M Main, A Magalski, J Webb, A Cheung, J Ye, S Lichtenstein, E Zwanenburg, C Thompson, I L Kron, S Lim, G Ailawadi, J Kern, M Ragosta, S Burks, K Gahring, J Dent, 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, R Waksman, P Okubagzi, D Whitman, F Asch, S Goldstein, Z Wang, Craig R Smith, Martin B Leon, Michael J Mack, D Craig Miller, Jeffrey W Moses, Lars G Svensson, E Murat Tuzcu, John G Webb, Gregory P Fontana, Raj R Makkar, Mathew Williams, Todd Dewey, Samir Kapadia, Vasilis Babaliaros, Vinod H Thourani, Paul Corso, Augusto D Pichard, Joseph E Bavaria, Howard C Herrmann, Jodi J Akin, William N Anderson, Duolao Wang, Stuart J Pocock, PARTNER Trial Investigators, M B Leon, C Smith, M Mack, D C Miller, J Moses, L Svensson, M Tuzcu, J Webb, Jodi J Akin, Karen Foley, G Dziem, 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, B R Lindman, L Cohn, A Eisenhauer, F Welt, M Davidson, T Charleson, W Gross, R Makkar, G Fontana, A Trento, S Kar, M Gheorghiu, A Doumanian, J Stegic, K Tolstrup, R Siegel, M Tuzcu, L Svensson, S Kapadia, E Roselli, R Bartow, C Gerace, L Rodriguez, W Stewart, R Grim, R Savage, A Alfirevic, L Wallace, M Leon, C Smith, J Moses, S Kodali, M Williams, M Hawkey, S Schnell, R Hahn, L Gillam, S Chiu Wong, K Krieger, G Bergman, A Salemi, D Reynolds, R B Devereux, P Block, R Guyton, V Babaliaros, V Thourani, E Tequia, F Carter, S Lerakis, R Martin, S Howell, B Whisenant, K Jones, S Clayson, J Revenaugh, B Miller, J Flores, J Rodes-Cabau, D Doyle, Dumont, R Delarochelliere, J Aube, F Mohr, G Schuler, T Walther, S Ott, I Palacios, G Vlahakes, A Agnihotri, I Inglessis, M Daher, J Passeri, D Holmes, T Sundt, C Rihal, K Greason, B Anderson, D Rolbiecki, H Michelena, M Sarano, K Andrew, T Dewey, D Brown, B Bowers, M Mack, W Brinkman, C McKibben, A Kenady, J Foreman, K Roper, D Gopal, J Horswell, L Michelsen, 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, S Ramee, G Parrino, T Collins, M Bates, B Hirstius, L Bienvenu, P Teirstein, S Brewster, J Tyner, C Stinis, M Price, S Clarke, T Buchanan, E Anderson, D C Miller, A Yeung, W Fearon, M Fischbein, M Speight, C McWard, D Liang, D Cohen, K Allen, J A Grantham, M Borkon, A Chhatriwalla, J Hall, M Miller, M Main, A Magalski, J Webb, A Cheung, J Ye, S Lichtenstein, E Zwanenburg, C Thompson, I L Kron, S Lim, G Ailawadi, J Kern, M Ragosta, S Burks, K Gahring, J Dent, 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, R Waksman, P Okubagzi, D Whitman, F Asch, S Goldstein, Z Wang
Abstract
Background: The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.
Methods: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.
Results: The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.
Conclusions: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
Source: PubMed