International geographic variation in event rates in trials of heart failure with preserved and reduced ejection fraction

Kristensen, S. L. L. et al. (2015) International geographic variation in event rates in trials of heart failure with preserved and reduced ejection fraction. Circulation, 131(1), pp. 43-53. (doi:10.1161/CIRCULATIONAHA.114.012284)

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Publisher's URL: http://dx.doi.org/10.1161/CIRCULATIONAHA.114.012284

Abstract

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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Kristensen, Mr Soren Lund and Jhund, Dr Pardeep and McMurray, Professor John
Authors: Kristensen, S. L. L., Køber, L., Jhund, P. S., Solomon, S. D., Kjekshus, J., McKelvie, R. S., Zile, M. R., Granger, C. B., Wikstrand, J., Komajda, M., Carson, P. E., Pfeffer, M. A., Swedberg, K., Wedel, H., Yusuf, S., and McMurray, J. J. V.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Circulation
Publisher:American Heart Association
ISSN:0009-7322
ISSN (Online):1524-4539
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