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Aortic Valve Replacement in Women: A Pooled Analysis of the RHEIA and PARTNER 3 Trials

H. Eltchaninoff, S. Windecker, MJ. Mack, P. Pibarot, VH. Thourani, JJ. Bax, DJ. Cohen, N. Bonaros, R. Makkar, S. Bleiziffer, WY. Szeto, P. Berthoumieu, RT. Hahn, T. Hovorka, J. Mareš, J. Taylor, D. Tchetche, MB. Leon

. 2025 ; 18 (12) : 1540-1553. [pub] 20250623

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, srovnávací studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25015272

BACKGROUND: In women with severe aortic stenosis, there are limited data regarding outcome differences following transcatheter (TAVR) vs surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to examine outcomes of TAVR vs SAVR in a patient-level pooled analysis of women in the RHEIA and PARTNER 3 trials. METHODS: Patients in both trials were randomly allocated to a balloon-expandable SAPIEN 3/Ultra valve or to surgical bioprostheses. Individual patient data of female participants in the 2 trials were pooled. The primary endpoint was all-cause mortality, all stroke, or rehospitalization at 1 year. RESULTS: A total of 376 women were randomized to TAVR and 336 to SAVR. The mean age was ∼73 years, and the mean Society of Thoracic Surgeons (STS) score was 2.1%. Kaplan-Meier estimates of event rates at 1 year with TAVR vs SAVR were 8.5% vs 16.8% for the composite of all-cause mortality, all stroke, or rehospitalization (absolute difference -8.2%; 95% CI: -13.1% to -3.3%; P < 0.001), 1.1% vs 2.1% (P = 0.27) for all-cause mortality, 2.7% vs 3.9% (P = 0.35) for all stroke, and 5.4% vs 11.9% (P = 0.002) for rehospitalization. The composite endpoint of all-cause death or stroke was similar between the 2 treatment groups: 3.5% vs 5.4% (absolute difference -1.9%; 95% CI: -5.0% to 1.1%; P = 0.21). CONCLUSIONS: Among women with symptomatic severe aortic stenosis, TAVR led to a reduction in the rate of the combined endpoint of all-cause mortality, stroke, or rehospitalization at 1-year follow-up, largely due to a significant reduction in the rate of rehospitalization.

Citace poskytuje Crossref.org

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$a BACKGROUND: In women with severe aortic stenosis, there are limited data regarding outcome differences following transcatheter (TAVR) vs surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to examine outcomes of TAVR vs SAVR in a patient-level pooled analysis of women in the RHEIA and PARTNER 3 trials. METHODS: Patients in both trials were randomly allocated to a balloon-expandable SAPIEN 3/Ultra valve or to surgical bioprostheses. Individual patient data of female participants in the 2 trials were pooled. The primary endpoint was all-cause mortality, all stroke, or rehospitalization at 1 year. RESULTS: A total of 376 women were randomized to TAVR and 336 to SAVR. The mean age was ∼73 years, and the mean Society of Thoracic Surgeons (STS) score was 2.1%. Kaplan-Meier estimates of event rates at 1 year with TAVR vs SAVR were 8.5% vs 16.8% for the composite of all-cause mortality, all stroke, or rehospitalization (absolute difference -8.2%; 95% CI: -13.1% to -3.3%; P < 0.001), 1.1% vs 2.1% (P = 0.27) for all-cause mortality, 2.7% vs 3.9% (P = 0.35) for all stroke, and 5.4% vs 11.9% (P = 0.002) for rehospitalization. The composite endpoint of all-cause death or stroke was similar between the 2 treatment groups: 3.5% vs 5.4% (absolute difference -1.9%; 95% CI: -5.0% to 1.1%; P = 0.21). CONCLUSIONS: Among women with symptomatic severe aortic stenosis, TAVR led to a reduction in the rate of the combined endpoint of all-cause mortality, stroke, or rehospitalization at 1-year follow-up, largely due to a significant reduction in the rate of rehospitalization.
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$a Windecker, Stephan $u Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
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$a Mack, Michael J $u Baylor Scott & White Health, Plano, Texas, USA
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$a Pibarot, Philippe $u Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
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$a Thourani, Vinod H $u Piedmont Heart Institute, Atlanta, Georgia, USA
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$a Bax, Jeroen J $u Leiden University Medical Center, Leiden, the Netherlands
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$a Cohen, David J $u St. Francis Hospital, Roslyn, New York, USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA
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$a Bonaros, Nikolaos $u Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
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$a Makkar, Raj $u Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
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$a Bleiziffer, Sabine $u Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
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$a Szeto, Wilson Y $u Perelman School of Medicine at the University of Pennsylvania, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
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$a Berthoumieu, Pierre $u Department of Cardiac and Thoracic Surgery, Clinic Pasteur, Toulouse, France
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$a Hahn, Rebecca T $u Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA
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$a Hovorka, Tomas $u Edwards Lifesciences, Prague, Czech Republic
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$a Mareš, Jan $u Department of Data Science, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
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$a Taylor, Jennifer $u Edwards Lifesciences, London, United Kingdom
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