JACC: Heart Failure 2013 by the American College of Cardiology Foundation Published by Elsevier Inc.
Vol. 1, No. 6, 2013 ISSN 2213-1779/$36.00 http://dx.doi.org/10.1016/j.jchf.2013.07.004
Differences in Treatment, Outcomes, and Quality of Life Among Patients With Heart Failure in Canada and the United States Padma Kaul, PHD,* Shelby D. Reed, PHD,yz Adrian F. Hernandez, MD, MPH,z Jonathan G. Howlett, MD,x Justin A. Ezekowitz, MBBCH, MSC,* Yanhong Li, MD,yz Yinggan Zheng, MA, MED,* Jean L. Rouleau, MD,k Randall C. Starling, MD,{ Christopher M. O’Connor, MD,z Robert M. Califf, MD,# Paul W. Armstrong, MD* Edmonton and Calgary, Alberta, and Montreal, Quebec, Canada; Durham, North Carolina; and Cleveland, Ohio Objectives
The aim of this study was to compare clinical outcomes, resource utilization, and health-related quality of life between Canadian and U.S. patients enrolled in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). A further aim was to supplement the within-trial analysis with a contemporaneous population-based comparison of all patients hospitalized with primary diagnoses of heart failure (HF) in the 2 countries.
Background
Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States.
Methods
Trial patients consisted of 465 Canadian and 2,684 U.S. patients enrolled in ASCEND-HF. Population-level cohorts consisted of 1.9 million U.S. and 81,016 Canadians hospitalized for HF in 2007 and 2008.
Results
Canadian patients in ASCEND-HF were older, were more likely to be white, and had lower body weights and blood pressures than U.S. patients. Canadians also had lower baseline-adjusted odds of 30-day mortality (odds ratio: 0.46; 95% confidence interval: 0.23 to 0.92) and better health-related quality of life than U.S. patients. In both countries, trial patients differed significantly from population-level cohorts. In contrast to ASCEND-HF, unadjusted in-hospital mortality at the population level was significantly lower in the United States (3.4%) compared with Canada (11.1%) (p < 0.01).
Conclusions
Intercountry differences in outcomes of patients hospitalized with HF differed significantly between trial and population cohorts. Further study on how cardiac care is delivered in the 2 countries and how it influences the results of clinical trials and population-level outcomes, especially in the long term, is warranted. (A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure; NCT00475852) (J Am Coll Cardiol HF 2013;1:523–30) ª 2013 by the American College of Cardiology Foundation
Differences in the management of patients with acute myocardial infarction in Canada and the United States are well documented (1–6). However, less is known about From the *Division of Cardiology, Department of Medicine, University of Alberta, and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; yCenter for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, North Carolina; zDuke Clinical Research Institute, Durham, North Carolina; xDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada; kMontreal Heart Institute, Montreal, Quebec, Canada; {Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio; and the #Duke Translational Medicine Institute, Duke University School of Medicine, Durham, North Carolina. ASCEND-HF was funded by Scios Inc. Individual financial disclosures pertaining to the original ASCEND-HF study have been previously published online. Dr. Hernandez has relationships with Janssen, Corthera, and Amgen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Javed Butler, MD, served as Guest Editor for this paper. Manuscript received May 28, 2013; revised manuscript received July 17, 2013, accepted July 25, 2013.
intercountry differences in the treatment and outcomes of patients hospitalized with acute decompensated heart failure (HF). Ko et al. (7) compared short-term and long-term mortality among elderly U.S. Medicare beneficiaries hospitalized with HF between 1998 and 2001 and a similarly aged cohort of patients in Ontario, Canada. They found that 30-day mortality rates were lower in the United States, but by 1 year, the mortality differences between the 2 countries had dissipated. Whether these findings persist in contemporary practice and extend to patients under the age of 65 years is not known. Also, no previous study has compared health-related quality of life (HRQOL) among patients with HF in the 2 countries. Accordingly, we compared clinical outcomes, resource utilization, and HRQOL between Canadian and U.S. patients enrolled in ASCEND-HF (Acute Study of Clinical
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Kaul et al. Canadian-U.S. Differences in Heart Failure
Effectiveness of Nesiritide in Decompensated Heart Failure) (8). Although patients enrolled in HF = heart failure clinical trials have the advantage HRQOL = health-related of being relatively homogenous, quality of life they may not be representative of the overall populations with the disease in the 2 countries. We therefore supplemented our within-trial analysis with a contemporaneous populationbased comparison of all patients hospitalized with primary diagnoses of HF in the 2 countries. Abbreviations and Acronyms
Methods ASCEND-HF trial and study population. The study design and results of ASCEND-HF have been previously published (8,9). Briefly, ASCEND-HF evaluated nesiritide versus placebo in patients with acute decompensated HF enrolled within 24 h of first intravenous HF-related treatment. Participants were required to have each of the following at the time of randomization: dyspnea at rest or with minimal activity, 1 accompanying sign (respiratory rate 20 breaths/min or pulmonary congestion or edema with rales 1/3 baseline), and 1 objective measure of HF (evidence of congestion or edema on chest x-ray, B-type natriuretic peptide 400 pg/ml or N-terminal pro–B-type natriuretic peptide 1,000 pg/ml, pulmonary capillary wedge pressure >20 mm Hg, or left ventricular ejection fraction
Vol. 1, No. 6, 2013 ISSN 2213-1779/$36.00 http://dx.doi.org/10.1016/j.jchf.2013.07.004
Differences in Treatment, Outcomes, and Quality of Life Among Patients With Heart Failure in Canada and the United States Padma Kaul, PHD,* Shelby D. Reed, PHD,yz Adrian F. Hernandez, MD, MPH,z Jonathan G. Howlett, MD,x Justin A. Ezekowitz, MBBCH, MSC,* Yanhong Li, MD,yz Yinggan Zheng, MA, MED,* Jean L. Rouleau, MD,k Randall C. Starling, MD,{ Christopher M. O’Connor, MD,z Robert M. Califf, MD,# Paul W. Armstrong, MD* Edmonton and Calgary, Alberta, and Montreal, Quebec, Canada; Durham, North Carolina; and Cleveland, Ohio Objectives
The aim of this study was to compare clinical outcomes, resource utilization, and health-related quality of life between Canadian and U.S. patients enrolled in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). A further aim was to supplement the within-trial analysis with a contemporaneous population-based comparison of all patients hospitalized with primary diagnoses of heart failure (HF) in the 2 countries.
Background
Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States.
Methods
Trial patients consisted of 465 Canadian and 2,684 U.S. patients enrolled in ASCEND-HF. Population-level cohorts consisted of 1.9 million U.S. and 81,016 Canadians hospitalized for HF in 2007 and 2008.
Results
Canadian patients in ASCEND-HF were older, were more likely to be white, and had lower body weights and blood pressures than U.S. patients. Canadians also had lower baseline-adjusted odds of 30-day mortality (odds ratio: 0.46; 95% confidence interval: 0.23 to 0.92) and better health-related quality of life than U.S. patients. In both countries, trial patients differed significantly from population-level cohorts. In contrast to ASCEND-HF, unadjusted in-hospital mortality at the population level was significantly lower in the United States (3.4%) compared with Canada (11.1%) (p < 0.01).
Conclusions
Intercountry differences in outcomes of patients hospitalized with HF differed significantly between trial and population cohorts. Further study on how cardiac care is delivered in the 2 countries and how it influences the results of clinical trials and population-level outcomes, especially in the long term, is warranted. (A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure; NCT00475852) (J Am Coll Cardiol HF 2013;1:523–30) ª 2013 by the American College of Cardiology Foundation
Differences in the management of patients with acute myocardial infarction in Canada and the United States are well documented (1–6). However, less is known about From the *Division of Cardiology, Department of Medicine, University of Alberta, and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; yCenter for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, North Carolina; zDuke Clinical Research Institute, Durham, North Carolina; xDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada; kMontreal Heart Institute, Montreal, Quebec, Canada; {Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio; and the #Duke Translational Medicine Institute, Duke University School of Medicine, Durham, North Carolina. ASCEND-HF was funded by Scios Inc. Individual financial disclosures pertaining to the original ASCEND-HF study have been previously published online. Dr. Hernandez has relationships with Janssen, Corthera, and Amgen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Javed Butler, MD, served as Guest Editor for this paper. Manuscript received May 28, 2013; revised manuscript received July 17, 2013, accepted July 25, 2013.
intercountry differences in the treatment and outcomes of patients hospitalized with acute decompensated heart failure (HF). Ko et al. (7) compared short-term and long-term mortality among elderly U.S. Medicare beneficiaries hospitalized with HF between 1998 and 2001 and a similarly aged cohort of patients in Ontario, Canada. They found that 30-day mortality rates were lower in the United States, but by 1 year, the mortality differences between the 2 countries had dissipated. Whether these findings persist in contemporary practice and extend to patients under the age of 65 years is not known. Also, no previous study has compared health-related quality of life (HRQOL) among patients with HF in the 2 countries. Accordingly, we compared clinical outcomes, resource utilization, and HRQOL between Canadian and U.S. patients enrolled in ASCEND-HF (Acute Study of Clinical
524
Kaul et al. Canadian-U.S. Differences in Heart Failure
Effectiveness of Nesiritide in Decompensated Heart Failure) (8). Although patients enrolled in HF = heart failure clinical trials have the advantage HRQOL = health-related of being relatively homogenous, quality of life they may not be representative of the overall populations with the disease in the 2 countries. We therefore supplemented our within-trial analysis with a contemporaneous populationbased comparison of all patients hospitalized with primary diagnoses of HF in the 2 countries. Abbreviations and Acronyms
Methods ASCEND-HF trial and study population. The study design and results of ASCEND-HF have been previously published (8,9). Briefly, ASCEND-HF evaluated nesiritide versus placebo in patients with acute decompensated HF enrolled within 24 h of first intravenous HF-related treatment. Participants were required to have each of the following at the time of randomization: dyspnea at rest or with minimal activity, 1 accompanying sign (respiratory rate 20 breaths/min or pulmonary congestion or edema with rales 1/3 baseline), and 1 objective measure of HF (evidence of congestion or edema on chest x-ray, B-type natriuretic peptide 400 pg/ml or N-terminal pro–B-type natriuretic peptide 1,000 pg/ml, pulmonary capillary wedge pressure >20 mm Hg, or left ventricular ejection fraction
