Division of Cardiology, Department of Medicine, University of Alberta, and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
JACC Heart Fail. 2013 Dec;1(6):523-30. doi: 10.1016/j.jchf.2013.07.004. Epub 2013 Oct 23.
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.
Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States.
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.
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).
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).
本研究旨在比较加拿大和美国 ASCEND-HF 试验（急性失代偿心力衰竭中奈西立肽临床疗效研究）中入组患者的临床结局、资源利用情况和健康相关生活质量，并补充一项同期两国因心力衰竭（HF）住院的所有患者的基于人群的比较。背景：对于加拿大和美国 HF 患者的结局方面的国际差异知之甚少。方法：试验患者包括 ASCEND-HF 中入组的 465 名加拿大患者和 2684 名美国患者。人群队列由 2007 年和 2008 年因 HF 住院的 190 万美国人和 81016 名加拿大人组成。结果：ASCEND-HF 中的加拿大患者年龄较大，更可能是白人，体重和血压较低。与美国患者相比，加拿大患者 30 天死亡率的基线调整比值比也较低（比值比：0.46；95%置信区间：0.23 至 0.92），健康相关生活质量更好。在两个国家，试验患者与人群队列之间存在显著差异。与 ASCEND-HF 不同，人群水平的未调整住院死亡率在美国（3.4%）显著低于加拿大（11.1%）（p<0.01）。结论：HF 住院患者结局的国际差异在试验和人群队列之间存在显著差异。需要进一步研究两个国家的心脏护理方式及其如何影响临床试验和人群水平结局，尤其是长期结局。（急性失代偿心力衰竭患者奈西立肽有效性研究；NCT00475852）。
