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)

J Am Coll Cardiol. 2014 Mar 25;63(11):1090-9. doi: 10.1016/j.jacc.2013.10.057. Epub 2013 Nov 27.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / complications
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery
  • Aortic Valve Stenosis / therapy*
  • Cardiac Catheterization / methods*
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / diagnosis*
  • Diabetes Mellitus, Type 2 / mortality
  • Echocardiography, Doppler
  • Evaluation Studies as Topic
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / methods*
  • Heart Valve Prosthesis Implantation / mortality
  • Hospital Mortality*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Minimally Invasive Surgical Procedures / methods
  • Minimally Invasive Surgical Procedures / mortality
  • Postoperative Complications / mortality
  • Postoperative Complications / prevention & control
  • Proportional Hazards Models
  • Risk Assessment
  • Severity of Illness Index
  • Sex Factors
  • Statistics, Nonparametric
  • Survival Rate
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00530894