Padma Kaul1, Shelby D Reed2, Adrian F Hernandez3, Jonathan G Howlett4, Justin A Ezekowitz5, Yanhong Li2, Yinggan Zheng5, Jean L Rouleau6, Randall C Starling7, Christopher M O'Connor3, Robert M Califf8, Paul W Armstrong5. 1. Division of Cardiology, Department of Medicine, University of Alberta, and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada. Electronic address: pkaul@ualberta.ca. 2. Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. 3. Duke Clinical Research Institute, Durham, North Carolina. 4. Department of Medicine, University of Calgary, Calgary, Alberta, Canada. 5. Division of Cardiology, Department of Medicine, University of Alberta, and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada. 6. Montreal Heart Institute, Montreal, Quebec, Canada. 7. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. 8. Duke Translational Medicine Institute, Duke University School of Medicine, Durham, North Carolina.
Abstract
OBJECTIVES: The aim of this study was to compare clinical outcomes, resource utilization, and health-related quality of lifebetween 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).
RCT Entities:
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).
Authors: Marc D Samsky; Andrew P Ambrosy; Erik Youngson; Li Liang; Padma Kaul; Adrian F Hernandez; Eric D Peterson; Finlay A McAlister Journal: JAMA Cardiol Date: 2019-05-01 Impact factor: 14.676
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