Living in the United States/Canada versus Eastern Europe/Russia was associated with higher heart failure hospitalization rates in HF-PEF patients (adjusted HR 1.34; 95% CI 1.01-1.74; P=0.04).
Observational
Yes
Does international geographic region affect event rates in trials of heart failure with preserved and reduced ejection fraction?
Significant international geographic variation exists in heart failure hospitalization rates, particularly in HF-PEF, which has important implications for the design and conduct of future global clinical trials.
Effect estimate: adjusted HR 1.34 (95% CI 1.01-1.74)
Absolute Event Rate: 7.6% vs 3.3%
p-value: p=0.04
BACKGROUND: International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction (HF-REF), but there are few data for those with preserved ejection fraction (HF-PEF). METHODS AND RESULTS: We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial (I-Preserve), the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved trial, the CHARM-Alternative and CHARM-Added HF-REF trials, and the Controlled Rosuvastatin Multinational Trial in HF-REF (CORONA). Crude rates of heart failure hospitalization varied by geographic region, and more so for HF-PEF than for HF-REF. Rates in patients with HF-PEF were highest in the United States/Canada (HF hospitalization rate 7.6 per 100 patient-years in I-Preserve; 8.8 in CHARM-Preserved), intermediate in Western Europe (4.8/100 and 4.7/100), and lowest in Eastern Europe/Russia (3.3/100 and 2.8/100). The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables: adjusted hazard ratios 1.34 (95% confidence interval, 1.01-1.74; P=0.04) in I-Preserve and 1.85 (95% confidence interval, 1.17-2.91; P=0.01) in CHARM-Preserved. In HF-REF, rates of HF hospitalization were slightly lower in Western Europe compared with other regions. For both HF-REF and HF-PEF, there were few regional differences in rates of all-cause or cardiovascular mortality. CONCLUSIONS: The differences in event rates observed suggest there is international geographic variation in 1 or more of the definition and diagnosis of HF-PEF, the risk profile of patients enrolled, and the threshold for hospitalization, which has implications for the conduct of future global trials.
Kristensen et al. (Wed,) conducted a observational in Heart failure with preserved and reduced ejection fraction. United States/Canada region vs. Eastern Europe/Russia region was evaluated on Heart failure hospitalization (adjusted HR 1.34, 95% CI 1.01-1.74, p=0.04). Living in the United States/Canada versus Eastern Europe/Russia was associated with higher heart failure hospitalization rates in HF-PEF patients (adjusted HR 1.34; 95% CI 1.01-1.74; P=0.04).