Six-Year Outcomes After Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
John K. Forrest, Steven J. Yakubov, G. Michael Deeb, Michael J. Reardon, Paul Sorajja, Timothy Byrne, Merick Kirshner, Tanvir Bajwa, John Crouch, Joseph Coselli, Guilherme Silva, Robert C. Stoler, Ashequl Islam, Anthony J. Rousou, Marie‐France Poulin, Kamal Khabbaz, Mark Bladergroen, Peter Fail, Donald Netherland, Ka Yan Lam, W. A. L. Tonino, Arnaud Sudre, Pierre Berthoumieu, Didier Tchétché, Jeffrey Newman, G. Chad Hughes, J Kevin Harrison, Ajanta De, Nicolas M. van Mieghem, Gerald Yong, Shikhar Agarwal, Steven Park, Jonathan A. Rapp, Neal Kleiman, Michael Reardon, Siamak Mohammadi, Josep Rodes-Cabau, Jeffrey M. Sparling, C. Craig Elkins, Michele Gallo, Ray Matthews, Vaughn A. Starnes, Kenji Ando, Arnaud Farge, Thomas Hovasse, Michael DeFrain, Murali Muppala, Apurva Vyas, Rodrigo Bagur, Michael Chu, Gregory Fontana, Visha Dev, J. Michael Tuchek, Ignacio Inglessis Azuaje, Serguei Melnitchouk, Nicolo Piazza, Kevin Lacappelle, Daniel Steinberg, Marc Katz, John Wang, Joseph A. Kozina, Robert C. Merritt, Atul Chawla, Bart Jensen, Jorge Alvarez, Robert Gooley, JULIAN III SMITH, Réda Ibrahim, Raymond Cartier, Joshua Rovin, Satsuki Fukushima, Bruce Rutkin, Steven J. Yakubov, Howard K. Song, Firas Zahr, Shigeru Miyagawa, Vivek Rajagopal, Arun Kanmanthareddy, Mubashir Mumtaz, Ravinay Bhindi, Peter Brady, Sanjay Batra, Thomas Davis, Ayman Iskander, David Heimansohn, James Hermiller, Itaru Takamisawa, Thomas Haldis, Seiji Yamazaki, Paul S. Teirstein, Norio Tada, Shigeru Saito, William Merhi, Stephane Leung, David I Müller, Leonardus Timmers, George Petrossian, Newell Robinson, Peter Knight, Frederick Ling
Abstract
BACKGROUND: The Evolut Low Risk trial enrolled patients with severe aortic stenosis at low surgical risk. Annual follow-up is planned for 10 years, evaluating the composite of all-cause mortality or disabling stroke and key secondary endpoints. OBJECTIVES: Our prespecified objective was to report the 6-year clinical outcomes of transcatheter aortic valve replacement (TAVR) vs surgery from the Evolut Low Risk trial. Given an increase in reintervention rates at 6 years, we performed additional analyses in available 7-year data. METHODS: Low-risk patients with severe symptomatic aortic stenosis were randomized to TAVR or surgery from 2016-2019. Prespecified analyses at 6 years included annual follow-up of clinical outcomes reported as Kaplan-Meier estimates with log-rank test. Because the trial enrolled patients over several years, at the time of data lock, a majority of patients had completed 7-year follow-up. Given an increased reintervention rate at 6 years in the TAVR arm, we performed additional analysis of 7-year data available at the time of the database lock. Reintervention rates are reported as cumulative incidence. RESULTS: A total of 1,414 patients underwent an attempted implantation (730 TAVR, 684 surgery). At 6 years, the composite endpoint of all-cause mortality or disabling stroke was 23.3% for TAVR and 20.4% for surgery (difference: 2.8% [95% CI: -1.9% to 7.6%]; P = 0.43). All-cause mortality with vital status sweep at 6 years was 23.3% (95% CI: 20.6%-26.4%) for TAVR and 20.2% (95% CI: 17.4%-23.3%) for surgery (P = 0.24). The reintervention rate at 6 years was 5.5% for TAVR and 3.3% for surgery (sHR: 1.66 [95% CI: 0.96-2.86]; P = 0.07). Using available 7-year follow-up (555 TAVR and 480 surgery), the reintervention rate for TAVR was 9.8% and for surgery was 6.0% (sHR: 1.68 [95% CI: 1.10-2.58]; P = 0.02). In the TAVR and surgery groups, the rate of reintervention for regurgitation was 5.6% vs 1.6% (sHR: 3.39 [95% CI: 1.62-7.07]; P < 0.001) and the rate of reintervention for stenosis was 3.6% vs 3.5% (sHR: 1.14 [95% CI: 0.61-2.15]; P = 0.70). CONCLUSIONS: The 6-year results from the Evolut Low Risk trial show no significant difference in the composite endpoint of all-cause mortality or disabling stroke. At 6 and 7 years, the TAVR arm had a higher reintervention rate compared with surgery, driven by an increased incidence of aortic regurgitation. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).