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3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

2023; Elsevier BV; Volume: 81; Issue: 17 Linguagem: Inglês

10.1016/j.jacc.2023.02.017

1558-3597

John K. Forrest, G. Michael Deeb, Steven J. Yakubov, Hemal Gada, Mubashir Mumtaz, Basel Ramlawi, Tanvir Bajwa, Paul S. Teirstein, Michael DeFrain, Murali Muppala, Bruce Rutkin, Atul Chawla, Bart Jenson, Stanley Chetcuti, Robert Stoler, Marie‐France Poulin, Kamal R. Khabbaz, Melissa M. Levack, Kashish Goel, Didier Tchétché, Ka Yan Lam, Pim A.L. Tonino, Saki Ito, Jae K. Oh, Jian Huang, Jeffrey J. Popma, Neal S. Kleiman, Michael J. Reardon, Paul Sorajja, Timothy Byrne, Merick Kirshner, Tanvir Bajwa, John Crouch, Joseph S. Coselli, Guilherme Silva, Robert F. Hebeler, Robert Stoler, Ashequl Islam, Anthony J. Rousou, Marie‐France Poulin, Kamal R. Khabbaz, Mark Bladergroen, Peter Fail, Donald Netherland, Ka Yan Lam, W. A. L. Tonino, Arnaud Sudre, Pierre Berthoumieu, Didier Tchétché, Houman Khalili, G. Chad Hughes, James Harrison, Ajanta De, Pei H. Tsau, Nicolas M. Van Mieghem, Robert Larbalestier, Gerald Yong, Shikhar Agarwal, William Martin, Steven Park, Neal S. Kleiman, Michael J. Reardon, Siamak Mohammadi, Josep Rodés‐Cabau, Jeffrey M. Sparling, C. Craig Elkins, Brian L. Ganzel, Ray Matthews, Vaughn A. Starnes, Kenji Andò, Bernard Chevalier, Arnaud Farge, Michael DeFrain, Murali Muppala, William Combs, Rodrigo Bagur, Michael Chu, Gregory P. Fontana, Visha Dev, Ferdinand Leya, J. Michael Tuchek, Ignacio Inglessis, Arminder S. Jassar, Nicolò Piazza, Kevin Lacappelle, Daniel Steinberg, Marc Katz, John Wang, Joseph A. Kozina, Frank N. Slachman, Robert E. Merritt, Atul Chawla, Bart Jensen, Jorge Santana Álvarez, Robert Gooley, J. Michael Smith, Réda Ibrahim, Raymond Cartier, Joshua D. Rovin, Tomoyuki Fujita, Bruce Rutkin, Steven J. Yakubov, Howard K. Song, Firas Zahr, Shigeru Miyagawa, Vivek Rajagopal, James Kauten, Hemal Gada, Mubashir Mumtaz, Ravinay Bhindi, Peter Brady, Sanjay Batra, Thomas Davis, Ayman Iskander, David Heimansohn, James Hermiller, Itaru Takamisawa, Thomas Haldis, Seiji Yamazaki, Paul Teirstein, Norio Tada, Shigeru Saito, William Merhi, Stephane Leung, David W.M. Muller, Robin H. Heijmen, George Petrossian, N. Bryce Robinson, Peter A. Knight, Frederick Ling, Sam Radhakrishnan, Stephen E. Fremes, Eric J. Lehr, Sameer Gafoor, Thomas Noel, Antony Walton, Jon R. Resar, David Adams, Samin K. Sharma, Scott Lilly, Peter Tadros, George L. Zorn, Harold L. Dauerman, Frank Ittleman, Erik Horlick, Chris Feindel, Frederick G.P. Welt, Vikas Sharma, Alan Markowitz, John D. Carroll, David A. Fullerton, Bartley P. Griffith, Anuj Gupta, Eduardo de Marchena, Tomás A. Salerno, Stanley Chetcuti, G. Michael Deeb, Ibrahim Sultan, Kashish Goel, Sanjeevan Pasupati, Neal D. Kon, David Zhao, Basel Ramlawi, John K. Forrest,

Aortic Disease and Treatment Approaches

Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low–surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: −1.8% at year 1; −2.0% at year 2; and −2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)