AIM: The aim of the study was to determine the influence of various risk factors on ST2 levels in patients with HFpEF and diabetes mellitus type 2 (T2DM).
MATERIALS AND METHODS: A total of one hundred and thirty-four patients (74 females and 60 males, 51 diabetic patients and 83 patients without T2DM with HFpEF were examined. Duration of HF and T2DM, common risk factors, such as smoking, overweight, clinical examination, parameters of carbohydrate and lipid metabolism, glomerular filtration rate (GFR) and M235T polymorphism of ATG have been used. Multivariate backward stepwise cox regression analysis was performed in Statistica 10,0. p<0,05 was considered statistically significant.
RESULTS: ST2 level in patients with HFpEF associated with T2DM exceeded this value in patients with HFpEF without T2DM and was 23.26 ng/ml (18.5: 29.3) vs. 20.39 ng/ml (18.3: 24.6), respectively (p<0,05). To assess the cumulative effect of the studied factors on the ST2 level, we performed the Cox's stepwise multivariate regression analysis. Smoking, HOMA-IR (Homeostatic Model Assessment for Insulin Resistance), glucose, HbA1 and insulin levels were found to be the most significant factors influencing ST2 levels in patients with HF and T2DM, indicating a significant effect of DM type 2 on ST2 concentration.
CONCLUSIONS: Smoking, HOMA-IR, glucose, HbA1, and insulin levels can significantly affect ST2 levels in patients with T2DM and HFpEF.
METHODS AND RESULTS: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients.
CONCLUSION: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.