Brian R Lindman1, Philippe Pibarot2, Suzanne V Arnold3, Rakesh M Suri4, Thomas C McAndrew5, Hersh S Maniar6, Alan Zajarias6, Susheel Kodali7, Ajay J Kirtane7, Vinod H Thourani8, E Murat Tuzcu9, Lars G Svensson9, Ron Waksman10, Craig R Smith11, Martin B Leon7. 1. Washington University School of Medicine, St. Louis, Missouri. Electronic address: blindman@dom.wustl.edu. 2. Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 3. Saint Luke's Mid-America Heart Institute, Kansas City, Missouri. 4. Mayo Clinic, Rochester, Minnesota. 5. Cardiovascular Research Foundation, New York, New York. 6. Washington University School of Medicine, St. Louis, Missouri. 7. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/New York Presbyterian Hospital, New York, New York. 8. Emory University School of Medicine, Atlanta, Georgia. 9. Cleveland Clinic Foundation, Cleveland, Ohio. 10. MedStar Washington Hospital Center, Washington, DC. 11. Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
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).
RCT Entities:
OBJECTIVES: The goal of this study was to determine whether a less-invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabeticpatients 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 diabeticpatients, 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 diabeticpatients, 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).
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