Abstract
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.
Highlights
Risk equations have been used to predict cardiovascular disease (CVD) events that facilitate clinical management for more than four decades [1]
In Australia, for example, the CVD risk assessment recommended by the National Vascular Disease Prevention Alliance is based on the Framingham equation from the US, which includes diabetes yes/no as its only diabetes-specific variable [4]
The United Kingdom Prospective Diabetes Study (UKPDS) calculator, which is specific for type 2 diabetes and based on an intervention trial conducted between 1977 and 1997 [6,7], estimated double the coronary heart disease (CHD) event rate than what occurred in the FDS1 cohort, with modest discrimination and poor calibration, even if stroke risk prediction was acceptable [5]
Summary
Risk equations have been used to predict cardiovascular disease (CVD) events that facilitate clinical management for more than four decades [1]. In Australia, for example, the CVD risk assessment recommended by the National Vascular Disease Prevention Alliance is based on the Framingham equation from the US, which includes diabetes yes/no as its only diabetes-specific variable [4]. We assessed this equation using data from participants with type 2 diabetes in the representative community-based Fremantle Diabetes Study Phase I (FDS1) cohort followed from recruitment between 1993 and 1996 and found poor discrimination (the ability to predict who will have a future event) and calibration (the agreement between overall predicted and observed event rates) [5]. Conclusions: A validated four-point MACE competing risk model reliably predicts key T2D CVD outcomes
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