International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

Søren L Kristensen; Lars Køber; Pardeep S Jhund; Scott D Solomon; John Kjekshus; Robert S McKelvie; Michael R Zile; Christopher B Granger; John Wikstrand; Michel Komajda; Peter E Carson; Marc A Pfeffer; Karl Swedberg; Hans Wedel; Salim Yusuf; John J V McMurray

doi:10.1161/circulationaha.114.012284

International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

Søren L Kristensen, Lars Køber, Pardeep S Jhund, Scott D Solomon, John Kjekshus, Robert S McKelvie, Michael R Zile, Christopher B Granger, John Wikstrand, Michel Komajda, Peter E Carson, Marc A Pfeffer, Karl Swedberg, Hans Wedel, Salim Yusuf, John J V McMurray

Institut for Klinisk Medicin

58 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Circulation
Vol/bind	131
Udgave nummer	1
Sider (fra-til)	43-53
Antal sider	11
ISSN	0009-7322
DOI	https://doi.org/10.1161/circulationaha.114.012284
Status	Udgivet - jan. 2015

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10.1161/circulationaha.114.012284

CIRCULATIONAHA.114.012284Forlagets udgivne version, 474 KB

Citationsformater

Kristensen, S. 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., & McMurray, J. J. V. (2015). International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction. Circulation, 131(1), 43-53. https://doi.org/10.1161/circulationaha.114.012284

Kristensen, SL, Køber, L, Jhund, PS, Solomon, SD, Kjekshus, J, McKelvie, RS, Zile, MR, Granger, CB, Wikstrand, J, Komajda, M, Carson, PE, Pfeffer, MA, Swedberg, K, Wedel, H, Yusuf, S & McMurray, JJV 2015, 'International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction', Circulation, bind 131, nr. 1, s. 43-53. https://doi.org/10.1161/circulationaha.114.012284

@article{1d53c977fca546059b1841df7cc16a56,

title = "International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction",

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.",

keywords = "Aged, Aged, 80 and over, Angiotensin II Type 1 Receptor Blockers, Benzimidazoles, Biphenyl Compounds, Canada, Europe, Female, Fluorobenzenes, Geography, Heart Failure, Hospitalization, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Pyrimidines, Risk Factors, Rosuvastatin Calcium, Russia, Stroke Volume, Sulfonamides, Tetrazoles, Treatment Outcome, United States",

author = "Kristensen, {S{\o}ren L} and Lars K{\o}ber and Jhund, {Pardeep S} and Solomon, {Scott D} and John Kjekshus and McKelvie, {Robert S} and Zile, {Michael R} and Granger, {Christopher B} and John Wikstrand and Michel Komajda and Carson, {Peter E} and Pfeffer, {Marc A} and Karl Swedberg and Hans Wedel and Salim Yusuf and McMurray, {John J V}",

note = "{\textcopyright} 2014 American Heart Association, Inc.",

year = "2015",

month = jan,

doi = "10.1161/circulationaha.114.012284",

language = "English",

volume = "131",

pages = "43--53",

journal = "Circulation",

issn = "0009-7322",

publisher = "AHA/ASA",

number = "1",

}

TY - JOUR

T1 - International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

AU - Kristensen, Søren L

AU - Køber, Lars

AU - Jhund, Pardeep S

AU - Solomon, Scott D

AU - Kjekshus, John

AU - McKelvie, Robert S

AU - Zile, Michael R

AU - Granger, Christopher B

AU - Wikstrand, John

AU - Komajda, Michel

AU - Carson, Peter E

AU - Pfeffer, Marc A

AU - Swedberg, Karl

AU - Wedel, Hans

AU - Yusuf, Salim

AU - McMurray, John J V

PY - 2015/1

Y1 - 2015/1

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Angiotensin II Type 1 Receptor Blockers

KW - Benzimidazoles

KW - Biphenyl Compounds

KW - Canada

KW - Europe

KW - Female

KW - Fluorobenzenes

KW - Geography

KW - Heart Failure

KW - Hospitalization

KW - Humans

KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors

KW - Male

KW - Middle Aged

KW - Pyrimidines

KW - Risk Factors

KW - Rosuvastatin Calcium

KW - Russia

KW - Stroke Volume

KW - Sulfonamides

KW - Tetrazoles

KW - Treatment Outcome

KW - United States

U2 - 10.1161/circulationaha.114.012284

DO - 10.1161/circulationaha.114.012284

M3 - Journal article

C2 - 25406306

SN - 0009-7322

VL - 131

SP - 43

EP - 53

JO - Circulation

JF - Circulation

IS - 1

ER -

International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

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