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Randomized Controlled Trial
. 2014 Mar 25;63(11):1090-9.
doi: 10.1016/j.jacc.2013.10.057. Epub 2013 Nov 27.

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  1 , Philippe Pibarot  2 , Suzanne V Arnold  3 , Rakesh M Suri  4 , Thomas C McAndrew  5 , Hersh S Maniar  6 , Alan Zajarias  6 , Susheel Kodali  7 , Ajay J Kirtane  7 , Vinod H Thourani  8 , E Murat Tuzcu  9 , Lars G Svensson  9 , Ron Waksman  10 , Craig R Smith  11 , Martin B Leon  7
Affiliations
Randomized Controlled Trial

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 et al. J Am Coll Cardiol. .

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.

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Conflict of interest statement

Disclosures: Dr. Lindman is a site co-investigator 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 PI for the PERCEVAL Trial (Sorin Medical), on the Steering Committee for the Portico Trial (St. Jude Medical), and co-Investigator for the PARTNER II (Edwards Lifesciences) and COAPT (Abbott) Trials. Dr. Zajarias is a member of the PARTNER Trial Steering Committee, site PI for the PARTNER Trial, and 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 a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Drs. Tuzcu, Svensson, Smith, and Leon are unpaid members of the PARTNER Executive Committee and have received travel reimbursements from Edwards Lifesciences for activities related to these positions. The other authors report no potential conflicts of interest.

Figures

Figure 1
Figure 1. Clinical outcomes stratified by diabetes in the high risk cohort of the PARTNER trial
Cox proportional hazards models were used to evaluate the hazard ratios for patients with (DM) and without (NDM) diabetes for the clinical outcomes shown and the interaction between diabetes status and treatment for each clinical outcome. Abbreviations: TAVR, transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement; DM, diabetes mellitus; NDM, non-diabetes mellitus; TF, transfemoral; TA, transapical.
Figure 2
Figure 2. Time-to-event curves for diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all diabetic patients (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 2
Figure 2. Time-to-event curves for diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all diabetic patients (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 2
Figure 2. Time-to-event curves for diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all diabetic patients (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 3
Figure 3. Time-to-event curves for non-diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for non-diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all patients without diabetes (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 3
Figure 3. Time-to-event curves for non-diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for non-diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all patients without diabetes (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
Figure 3
Figure 3. Time-to-event curves for non-diabetic patients for 1-year death from any cause
One-year time-to-event curves are shown for non-diabetic patients for death from any cause in the as-treated population of the PARTNER trial (treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)). The curves are shown for all patients without diabetes (A), those in the transfemoral (TF) cohort (B), and those in the transapical (TA) cohort (C). The event rates were calculated with the use of Kaplan-Meier methods and compared with the use of the log-rank test.
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