射血分数保留的心力衰竭的全球差异：PARAGON-HF 试验。
Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial.
机构信息
National Heart Centre Singapore (J.T., C.S.P.L.).
Duke-NUS Medical School, Singapore (J.T., C.S.P.L.).
出版信息
Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19.
BACKGROUND
Heart failure with preserved ejection fraction (HFpEF) is a global public health problem with important regional differences. We investigated these differences in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF), the largest and most inclusive global HFpEF trial.
METHODS
We studied differences in clinical characteristics, outcomes, and treatment effects of sacubitril/valsartan in 4796 patients with HFpEF from the PARAGON-HF trial, grouped according to geographic region.
RESULTS
Regional differences in patient characteristics and comorbidities were observed: patients from Western Europe were oldest (mean 75±7 years) with the highest prevalence of atrial fibrillation/flutter (36%); Central/Eastern European patients were youngest (mean 71±8 years) with the highest prevalence of coronary artery disease (50%); North American patients had the highest prevalence of obesity (65%) and diabetes (49%); Latin American patients were younger (73±9 years) and had a high prevalence of obesity (53%); and Asia-Pacific patients had a high prevalence of diabetes (44%), despite a low prevalence of obesity (26%). Rates of the primary composite end point of total hospitalizations for HF and death from cardiovascular causes were lower in patients from Central Europe (9 per 100 patient-years) and highest in patients from North America (28 per 100 patient-years), which was primarily driven by a greater number of total hospitalizations for HF. The effect of treatment with sacubitril-valsartan was not modified by region (interaction >0.05).
CONCLUSIONS
Among patients with HFpEF recruited worldwide in PARAGON-HF, there were important regional differences in clinical characteristics and outcomes, which may have implications for the design of future clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920711.
背景
射血分数保留的心力衰竭（HFpEF）是一个具有重要地域差异的全球性公共卫生问题。我们在 PARAGON-HF 试验（HFpEF 中血管紧张素受体-脑啡肽酶抑制剂与血管紧张素受体阻滞剂的全球预后前瞻性比较）中研究了这些差异，这是最大和最全面的全球 HFpEF 试验。
方法
我们根据地理位置将 PARAGON-HF 试验中的 4796 例 HFpEF 患者分为不同组，研究了他们的临床特征、结局和沙库巴曲缬沙坦的治疗效果的差异。
结果
观察到患者特征和合并症存在地域差异：西欧患者年龄最大（平均 75±7 岁），心房颤动/扑动的患病率最高（36%）；中欧/东欧患者年龄最小（平均 71±8 岁），冠心病的患病率最高（50%）；北美患者肥胖症（65%）和糖尿病（49%）的患病率最高；拉丁美洲患者最年轻（73±9 岁），肥胖症的患病率很高（53%）；亚太地区患者糖尿病的患病率很高（44%），尽管肥胖症的患病率较低（26%）。来自中欧的患者的主要复合终点（HF 总住院和心血管原因死亡）的发生率较低（每 100 患者年 9 例），而来自北美的患者最高（每 100 患者年 28 例），这主要是由于 HF 总住院人数较多所致。沙库巴曲缬沙坦治疗的效果不受地域影响（交互作用>0.05）。
结论
在 PARAGON-HF 中招募的全球 HFpEF 患者中，临床特征和结局存在重要的地域差异，这可能对未来临床试验的设计产生影响。登记：网址：https://www.clinicaltrials.gov；唯一标识符：NCT01920711。
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