Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk |
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| Authors: | Martin B. Leon Michael J. Mack Rebecca T. Hahn Vinod H. Thourani Raj Makkar Susheel K. Kodali Maria C. Alu Mahesh V. Madhavan Katherine H. Chau Mark Russo Samir R. Kapadia S. Chris Malaisrie David J. Cohen Philipp Blanke Jonathon A. Leipsic Mathew R. Williams James M. McCabe David L. Brown Philippe Pibarot |
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| Affiliation: | 1. Columbia University Irving Medical Center/NewYork Presbyterian Hospital, New York, New York, USA;2. Cardiovascular Research Foundation, New York, New York, USA;3. Baylor Scott & White Health, Plano, Texas, USA;4. Piedmont Heart Institute, Atlanta, Georgia, USA;5. Cedars Sinai Medical Center, Los Angeles, California, USA;6. Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA;7. Cleveland Clinic, Cleveland, Ohio, USA;8. Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA;9. University of Missouri-Kansas City, Kansas City, Missouri, USA;10. St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada;11. NYU-Langone Medical Center, New York, New York, USA;12. University of Washington, Seattle, Washington, USA;13. Emory University School of Medicine, Atlanta, Georgia, USA;14. Lankenau Institute for Medical Research, Main Line Health, Wynnewood, Pennsylvania, USA;15. University of Pennsylvania, Philadelphia, Pennsylvania, USA;p. Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, USA;q. University of Arizona College of Medicine, Phoenix, Arizona, USA;r. Edwards Lifesciences, Irvine, California, USA;s. Department of Medicine, Laval University, Quebec, Quebec, Canada |
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| Abstract: | BackgroundIn low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.ObjectivesThis study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.MethodsThis study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.ResultsPrimary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.ConclusionsAt 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114) |
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