Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)

Brian R. Lindman; Philippe Pibarot; Suzanne V. Arnold; Rakesh M. Suri; Thomas C. McAndrew; Hersh S. Maniar; Alan Zajarias; Susheel Kodali; Ajay J. Kirtane; Vinod H. Thourani; E. Murat Tuzcu; Lars G. Svensson; Ron Waksman; Craig R. Smith; Martin B. Leon

doi:10.1016/j.jacc.2013.10.057

Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)

Brian R. Lindman, Philippe Pibarot, Suzanne V. Arnold, Rakesh M. Suri, Thomas C. McAndrew, Hersh S. Maniar, Alan Zajarias, Susheel Kodali, Ajay J. Kirtane, Vinod H. Thourani, E. Murat Tuzcu, Lars G. Svensson, Ron Waksman, Craig R. Smith, Martin B. Leon

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

64 Scopus citations

Abstract

Objectives The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis >30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

Original language	English
Pages (from-to)	1090-1099
Number of pages	10
Journal	Journal of the American College of Cardiology
Volume	63
Issue number	11
DOIs	https://doi.org/10.1016/j.jacc.2013.10.057
State	Published - Mar 25 2014

Keywords

aortic stenosis
diabetes
transcatheter aortic valve replacement

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Lindman, B. R., Pibarot, P., Arnold, S. V., Suri, R. M., McAndrew, T. C., Maniar, H. S., Zajarias, A., Kodali, S., Kirtane, A. J., Thourani, V. H., Tuzcu, E. M., Svensson, L. G., Waksman, R., Smith, C. R., & Leon, M. B. (2014). Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve). Journal of the American College of Cardiology, 63(11), 1090-1099. https://doi.org/10.1016/j.jacc.2013.10.057

@article{fca03c8d80574b9c83fa55ef58894479,

title = "Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)",

abstract = "Objectives The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis >30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)",

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

author = "Lindman, {Brian R.} and Philippe Pibarot and Arnold, {Suzanne V.} and Suri, {Rakesh M.} and McAndrew, {Thomas C.} and Maniar, {Hersh S.} and Alan Zajarias and Susheel Kodali and Kirtane, {Ajay J.} and Thourani, {Vinod H.} and Tuzcu, {E. Murat} and Svensson, {Lars G.} and Ron Waksman and Smith, {Craig R.} and Leon, {Martin B.}",

note = "Funding Information: The PARTNER trial was funded by Edwards Lifesciences , and the protocol was developed jointly by the sponsor and study steering committee. The current analysis was conducted by academic investigators with no additional funding from Edwards Lifesciences . Dr. Lindman is supported by K23 HL116660 and the Washington University Institute of Clinical and Translational Sciences grant ( UL1 TR000448 , KL2 TR000450 ) from the National Center for Advancing Translational Sciences of the National Institutes of Health ; and is a site coinvestigator for the PARTNER Trial. Dr. Suri's institution (Mayo Clinic) receives randomized aortic valve replacement trial funding to the Division of Cardiovascular Surgery from Edwards Lifesciences, St. Jude Medical, and Sorin Medical ; and he is a national Principal Investigator for the PERCEVAL Trial (Sorin Medical), on the steering committee for the Portico Trial (St. Jude Medical), and coinvestigator for the PARTNER II (Edwards Lifesciences) and COAPT (Abbott) trials. Dr. Zajarias is a member of the PARTNER trial steering committee; is site Principal Investigator for the PARTNER trial; and is a consultant for Edwards Lifesciences. Dr. Kodali is a member of the PARTNER trial steering committee and consultant for Edwards Lifesciences, a member of the steering committee for the Portico trial (St. Jude Medical), and a member of the scientific advisory board of Thubrikar Aortic Valve. Dr. Thourani is a member of the PARTNER trial steering committee; and is a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Waksman is a member of the Speakers' Bureau of Boston Scientific, Medtronic, AstraZeneca, Biotronik, and Abbott Vascular. Drs. Tuzcu, Svensson, Smith, and Leon are unpaid members of the PARTNER Executive Committee; and has received travel reimbursements from Edwards Lifesciences for activities related to these positions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ",

year = "2014",

month = mar,

day = "25",

doi = "10.1016/j.jacc.2013.10.057",

language = "English",

volume = "63",

pages = "1090--1099",

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

issn = "0735-1097",

number = "11",

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Lindman, BR, Pibarot, P, Arnold, SV, Suri, RM, McAndrew, TC, Maniar, HS, Zajarias, A, Kodali, S, Kirtane, AJ, Thourani, VH, Tuzcu, EM, Svensson, LG, Waksman, R, Smith, CR & Leon, MB 2014, 'Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)', Journal of the American College of Cardiology, vol. 63, no. 11, pp. 1090-1099. https://doi.org/10.1016/j.jacc.2013.10.057

Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve). / Lindman, Brian R.; Pibarot, Philippe; Arnold, Suzanne V. et al.
In: Journal of the American College of Cardiology, Vol. 63, No. 11, 25.03.2014, p. 1090-1099.

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

TY - JOUR

T1 - Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery

T2 - An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)

AU - Lindman, Brian R.

AU - Pibarot, Philippe

AU - Arnold, Suzanne V.

AU - Suri, Rakesh M.

AU - McAndrew, Thomas C.

AU - Maniar, Hersh S.

AU - Zajarias, Alan

AU - Kodali, Susheel

AU - Kirtane, Ajay J.

AU - Thourani, Vinod H.

AU - Tuzcu, E. Murat

AU - Svensson, Lars G.

AU - Waksman, Ron

AU - Smith, Craig R.

AU - Leon, Martin B.

N1 - Funding Information: The PARTNER trial was funded by Edwards Lifesciences , and the protocol was developed jointly by the sponsor and study steering committee. The current analysis was conducted by academic investigators with no additional funding from Edwards Lifesciences . Dr. Lindman is supported by K23 HL116660 and the Washington University Institute of Clinical and Translational Sciences grant ( UL1 TR000448 , KL2 TR000450 ) from the National Center for Advancing Translational Sciences of the National Institutes of Health ; and is a site coinvestigator for the PARTNER Trial. Dr. Suri's institution (Mayo Clinic) receives randomized aortic valve replacement trial funding to the Division of Cardiovascular Surgery from Edwards Lifesciences, St. Jude Medical, and Sorin Medical ; and he is a national Principal Investigator for the PERCEVAL Trial (Sorin Medical), on the steering committee for the Portico Trial (St. Jude Medical), and coinvestigator for the PARTNER II (Edwards Lifesciences) and COAPT (Abbott) trials. Dr. Zajarias is a member of the PARTNER trial steering committee; is site Principal Investigator for the PARTNER trial; and is a consultant for Edwards Lifesciences. Dr. Kodali is a member of the PARTNER trial steering committee and consultant for Edwards Lifesciences, a member of the steering committee for the Portico trial (St. Jude Medical), and a member of the scientific advisory board of Thubrikar Aortic Valve. Dr. Thourani is a member of the PARTNER trial steering committee; and is a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Waksman is a member of the Speakers' Bureau of Boston Scientific, Medtronic, AstraZeneca, Biotronik, and Abbott Vascular. Drs. Tuzcu, Svensson, Smith, and Leon are unpaid members of the PARTNER Executive Committee; and has received travel reimbursements from Edwards Lifesciences for activities related to these positions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

PY - 2014/3/25

Y1 - 2014/3/25

N2 - Objectives The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis >30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

AB - Objectives The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high risk for surgery in the PARTNER (Placement of Aortic Transcatheter Valve) trial, we examined outcomes stratified according to diabetes status of patients randomly assigned to receive transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p = 0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (hazard ratio: 0.60 [95% confidence interval: 0.36 to 0.99]; p = 0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among nondiabetic patients, there was no significant difference in all-cause mortality at 1 year (p = 0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery; p = 0.88), but the rate of renal failure requiring dialysis >30 days was lower in the transcatheter group (0% vs. 6.1%; p = 0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter AVR compared with surgical AVR. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

KW - aortic stenosis

KW - diabetes

KW - transcatheter aortic valve replacement

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U2 - 10.1016/j.jacc.2013.10.057

DO - 10.1016/j.jacc.2013.10.057

M3 - Article

C2 - 24291272

AN - SCOPUS:84896505147

SN - 0735-1097

VL - 63

SP - 1090

EP - 1099

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 11

ER -

Lindman BR, Pibarot P, Arnold SV, Suri RM, McAndrew TC, Maniar HS et al. Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve). Journal of the American College of Cardiology. 2014 Mar 25;63(11):1090-1099. doi: 10.1016/j.jacc.2013.10.057

Transcatheter versus surgical aortic valve replacement in patients with diabetes and severe aortic stenosis at high risk for surgery: An analysis of the PARTNER trial (Placement of Aortic Transcatheter Valve)

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