Contemporary Cardiovascular Risk Assessment for Type 2 Diabetes Including Heart Failure as an Outcome: The Fremantle Diabetes Study Phase II

Background: Type 2 diabetes (T2D) cardiovascular disease (CVD) risk assessment has limitations. The aim of this study was to develop a risk equation adding heart failure (HF) to conventional major adverse cardiovascular events (MACE, myocardial infarction, stroke, and CVD death) and allowing for non-CVD death. Methods: 1551 community-based people with T2D (mean age 66 years, 52% males) were followed from baseline in 2008-2011 for five years to the first CVD event/death. Cox and competing risk regression identified predictors of three-point MACE and four-point MACE (including HF). Discrimination was assessed by the area under the receiver-operating characteristic curve (AUC) and calibration by the Hosmer-Lemeshow test. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were determined for a 10% five-year CVD risk cut-off. Results: 143 participants (9.2%) experienced a three-point MACE during 7,111 person-years of follow-up and 245 (15.8%) a four-point MACE during 6,896 person-years. The best model was the competing risk four-point MACE (221 predicted events (14.3%), AUC 0.82 (95% CI: 0.79-0.85), Hosmer-Lemeshow test, p = 0.17, sensitivity 79.2%, specificity 68.1%, PPV 31.8%, NPV 94.6%) with validation in 177 adults with T2D from an independent population (AUC 0.81 (0.74-0.89). Conclusions: A validated four-point MACE competing risk model reliably predicts key T2D CVD outcomes.