TY - JOUR
T1 - Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial)
AU - Skelding, Kimberly A.
AU - Yakubov, Steven J.
AU - Kleiman, Neal S.
AU - Reardon, Michael J.
AU - Adams, David H.
AU - Huang, Jian
AU - Forrest, John K.
AU - Popma, Jeffrey J.
N1 - Funding Information:
Dr. Skelding has received grant support and consultant fees/honoraria/speaker's bureau fees from Abbott. Dr. Yakubov has received grant support from Medtronic, Boston Scientific, and Direct Flow Medical and advisory board fees from Medtronic and Boston Scientific. Dr. Reardon has received consultant fees from Medtronic. Dr. Adams has received grant support from Medtronic and has royalty agreements with Medtronic and Edwards Lifesciences through the Mount Sinai School of Medicine. Dr. Huang is an employee of Medtronic. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speaker's bureau fees from Edwards Lifescience and Medtronic. Dr. Popma has received grant support from Medtronic, Boston Scientific, and Direct Flow Medical. Dr. Kleiman has no conflicts of interest to disclose.
Funding Information:
This study was funded by Medtronic (Minneapolis, Minnesota).
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/8/15
Y1 - 2016/8/15
N2 - The 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.
AB - The 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.
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U2 - 10.1016/j.amjcard.2016.05.051
DO - 10.1016/j.amjcard.2016.05.051
M3 - Article
C2 - 27381665
AN - SCOPUS:84990235698
VL - 118
SP - 560
EP - 566
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 4
ER -