-
Randomized Controlled Trial Comparative Study
Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial).
- Kimberly A Skelding, Steven J Yakubov, Neal S Kleiman, Michael J Reardon, David H Adams, Jian Huang, John K Forrest, and Jeffrey J Popma.
- Department of Cardiology, Geisinger Health System, Danville, Pennsylvania. Electronic address: kaskelding@geisinger.edu.
- Am. J. Cardiol. 2016 Aug 15; 118 (4): 560-6.
AbstractThe objective of this study was to compare outcomes in women after surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for SAVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in patients undergoing TAVR (33.3% vs 45.3%; p = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared with SAVR patients (12.7% vs 21.8%; p = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs 24.2%; p = 0.04). Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared with women undergoing SAVR, with both cohorts experiencing improved quality of life. Further studies specifically in women are warranted to validate these findings. Copyright © 2016 Elsevier Inc. All rights reserved.
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