Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve)

Mathew Williams; Susheel K. Kodali; Rebecca T. Hahn; Karin H. Humphries; Vuyisile T. Nkomo; David J. Cohen; Pamela S. Douglas; Michael Mack; Thomas C. McAndrew; Lars Svensson; Vinod H. Thourani; E. Murat Tuzcu; Neil J. Weissman; Ajay J. Kirtane; Martin B. Leon

doi:10.1016/j.jacc.2014.01.036

Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve)

Mathew Williams, Susheel K. Kodali, Rebecca T. Hahn, Karin H. Humphries, Vuyisile T. Nkomo, David J. Cohen, Pamela S. Douglas, Michael Mack, Thomas C. McAndrew, Lars Svensson, Vinod H. Thourani, E. Murat Tuzcu, Neil J. Weissman, Ajay J. Kirtane, Martin B. Leon

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

114 Scopus citations

Abstract

Objectives: This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background: The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods: In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results: Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions: In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities.

Original language	English (US)
Pages (from-to)	1522-1528
Number of pages	7
Journal	Journal of the American College of Cardiology
Volume	63
Issue number	15
DOIs	https://doi.org/10.1016/j.jacc.2014.01.036
State	Published - Apr 22 2014

Keywords

aortic stenosis
sex
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2014.01.036

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Williams, M., Kodali, S. K., Hahn, R. T., Humphries, K. H., Nkomo, V. T., Cohen, D. J., Douglas, P. S., Mack, M., McAndrew, T. C., Svensson, L., Thourani, V. H., Tuzcu, E. M., Weissman, N. J., Kirtane, A. J., & Leon, M. B. (2014). Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve). Journal of the American College of Cardiology, 63(15), 1522-1528. https://doi.org/10.1016/j.jacc.2014.01.036

Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve). / Williams, Mathew; Kodali, Susheel K.; Hahn, Rebecca T. et al.
In: Journal of the American College of Cardiology, Vol. 63, No. 15, 22.04.2014, p. 1522-1528.

Research output: Contribution to journal › Article › peer-review

Williams, M, Kodali, SK, Hahn, RT, Humphries, KH, Nkomo, VT, Cohen, DJ, Douglas, PS, Mack, M, McAndrew, TC, Svensson, L, Thourani, VH, Tuzcu, EM, Weissman, NJ, Kirtane, AJ & Leon, MB 2014, 'Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve)', Journal of the American College of Cardiology, vol. 63, no. 15, pp. 1522-1528. https://doi.org/10.1016/j.jacc.2014.01.036

Williams M, Kodali SK, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ et al. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve). Journal of the American College of Cardiology. 2014 Apr 22;63(15):1522-1528. doi: 10.1016/j.jacc.2014.01.036

@article{2abdfaa5688b446f84803c8ab372e676,

title = "Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve)",

abstract = "Objectives: This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background: The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods: In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results: Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions: In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities.",

keywords = "aortic stenosis, sex, transcatheter aortic valve replacement",

author = "Mathew Williams and Kodali, {Susheel K.} and Hahn, {Rebecca T.} and Humphries, {Karin H.} and Nkomo, {Vuyisile T.} and Cohen, {David J.} and Douglas, {Pamela S.} and Michael Mack and McAndrew, {Thomas C.} and Lars Svensson and Thourani, {Vinod H.} and Tuzcu, {E. Murat} and Weissman, {Neil J.} and Kirtane, {Ajay J.} and Leon, {Martin B.}",

note = "Funding Information: The PARTNER trial was funded by Edwards Lifesciences and designed collaboratively by the Steering Committee and the sponsor. The present analysis was carried out by academic investigators with no additional funding. Dr. Williams is a consultant for the PARTNER Trial Steering Committee and Edwards Lifesciences, and Medtronic. Dr. Kodali is a consultant for the PARTNER Trial Steering Committee, Edwards Lifesciences; and is on the Scientific Advisory Board of Thubrikar Aortic Valve, Inc. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, and Boston Scientific ; and is a consultant for Medtronic. Dr. Douglas has received institutional grant support from Edwards Lifesciences . Dr. Svensson has received travel reimbursements from Edwards Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee; holds equity in Cardiosolutions and ValvXchange; and has Intellectual Property Rights/Royalties from Posthorax. Drs. Mack, Tuzcu, and Leon have received travel reimbursements and are unpaid members of the PARTNER Trial Executive Committee and Edwards Lifesciences. Dr. Thourani is a consultant for the PARTNER Trial Steering Committee and Edwards Lifesciences; and is a consultant for Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Weissman has received research grants from Edwards Lifesciences, St. Jude Medical, Boston Scientific, Sorin Medical, Direct Flow, and MitralAlign . All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Williams and Kodali contributed equally to this work. ",

year = "2014",

month = apr,

day = "22",

doi = "10.1016/j.jacc.2014.01.036",

language = "English (US)",

volume = "63",

pages = "1522--1528",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

number = "15",

}

TY - JOUR

T1 - Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis

T2 - Insights from the partner trial (placement of aortic transcatheter valve)

AU - Williams, Mathew

AU - Kodali, Susheel K.

AU - Hahn, Rebecca T.

AU - Humphries, Karin H.

AU - Nkomo, Vuyisile T.

AU - Cohen, David J.

AU - Douglas, Pamela S.

AU - Mack, Michael

AU - McAndrew, Thomas C.

AU - Svensson, Lars

AU - Thourani, Vinod H.

AU - Tuzcu, E. Murat

AU - Weissman, Neil J.

AU - Kirtane, Ajay J.

AU - Leon, Martin B.

N1 - Funding Information: The PARTNER trial was funded by Edwards Lifesciences and designed collaboratively by the Steering Committee and the sponsor. The present analysis was carried out by academic investigators with no additional funding. Dr. Williams is a consultant for the PARTNER Trial Steering Committee and Edwards Lifesciences, and Medtronic. Dr. Kodali is a consultant for the PARTNER Trial Steering Committee, Edwards Lifesciences; and is on the Scientific Advisory Board of Thubrikar Aortic Valve, Inc. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, and Boston Scientific ; and is a consultant for Medtronic. Dr. Douglas has received institutional grant support from Edwards Lifesciences . Dr. Svensson has received travel reimbursements from Edwards Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee; holds equity in Cardiosolutions and ValvXchange; and has Intellectual Property Rights/Royalties from Posthorax. Drs. Mack, Tuzcu, and Leon have received travel reimbursements and are unpaid members of the PARTNER Trial Executive Committee and Edwards Lifesciences. Dr. Thourani is a consultant for the PARTNER Trial Steering Committee and Edwards Lifesciences; and is a consultant for Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Weissman has received research grants from Edwards Lifesciences, St. Jude Medical, Boston Scientific, Sorin Medical, Direct Flow, and MitralAlign . All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Williams and Kodali contributed equally to this work.

PY - 2014/4/22

Y1 - 2014/4/22

N2 - Objectives: This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background: The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods: In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results: Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions: In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities.

AB - Objectives: This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background: The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods: In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results: Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions: In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities.

KW - aortic stenosis

KW - sex

KW - transcatheter aortic valve replacement

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Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the partner trial (placement of aortic transcatheter valve)

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