心力衰竭中的种族因素：全球PARADIGM-HF和PARAGON-HF试验的汇总参与者水平分析
Race in Heart Failure: A Pooled Participant-Level Analysis of the Global PARADIGM-HF and PARAGON-HF Trials.
作者信息
Lu Henri, Claggett Brian L, Packer Milton, Pabon Maria A, Pfeffer Marc A, Lewis Eldrin F, Lam Carolyn S P, Rouleau Jean, Zile Michael R, Lefkowitz Martin, Desai Akshay S, Jhund Pardeep S, McMurray John J V, Solomon Scott D, Vaduganathan Muthiah
机构信息
Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Division of Cardiology, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland.
Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
出版信息
JACC Heart Fail. 2025 Jan;13(1):58-71. doi: 10.1016/j.jchf.2024.08.008. Epub 2024 Aug 31.
BACKGROUND
Mechanisms of disease pathobiology, prognosis, and potentially treatment responses might vary by race in patients with heart failure (HF).
OBJECTIVES
The authors aimed to examine the safety and efficacy of sacubitril/valsartan among patients with HF by self-reported race.
METHODS
PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and PARAGON-HF (Prospective Comparison of ARNI with ARB Global Outcomes in HF With Preserved Ejection Fraction) were global, randomized clinical trials testing sacubitril/valsartan against a renin-angiotensin system inhibitor (RASi) (enalapril or valsartan, respectively) in patients with HF and left ventricular ejection fraction ≤40% (PARADIGM-HF) or left ventricular ejection fraction ≥45% (PARAGON-HF). Patients with self-reported race were categorized as White, Asian, or Black. We assessed the composite of first HF hospitalization or cardiovascular death, its components, and angioedema across races.
RESULTS
Among 12,097 participants, 9,451 (78.1%) were White, 2,116 (17.5%) were Asian, and 530 (4.4%) were Black. Over a median follow-up of 2.5 years, Black (adjusted HR: 1.68; 95% CI: 1.42-1.98) and Asian patients (adjusted HR: 1.32; 95% CI: 1.18-1.47) experienced higher risks of the primary outcome compared with White patients. Treatment effects of sacubitril/valsartan vs RASi on the primary endpoint were consistent among White (HR: 0.84; 95% CI: 0.77-0.91), Asian (HR: 0.92; 95% CI: 0.78-1.10), and Black patients (HR: 0.79; 95% CI: 0.58-1.07; P = 0.58). Rates of severe angioedema were higher with sacubitril/valsartan vs RASi (White: 0.2% vs 0.1%; Black: 1.5% vs 0.0%; Asian: 0.1% vs 0.1%).
CONCLUSIONS
In a pooled experience of 2 global trials, Black and Asian patients exhibited a higher risk of cardiovascular events than White patients. The benefits of sacubitril/valsartan were consistent across races. Risks of severe angioedema were low but numerically higher with sacubitril/valsartan. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255; Prospective Comparison of ARNI with ARB Global Outcomes in HF With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).
背景
心力衰竭（HF）患者的疾病病理生物学机制、预后以及潜在的治疗反应可能因种族而异。
目的
作者旨在通过自我报告的种族来研究沙库巴曲缬沙坦在HF患者中的安全性和有效性。
方法
PARADIGM-HF（ARNI与ACEI对心力衰竭全球死亡率和发病率影响的前瞻性比较）和PARAGON-HF（ARNI与ARB对射血分数保留的心力衰竭全球结局的前瞻性比较）是全球性随机临床试验，在HF且左心室射血分数≤40%（PARADIGM-HF）或左心室射血分数≥45%（PARAGON-HF）的患者中，比较沙库巴曲缬沙坦与肾素-血管紧张素系统抑制剂（RASi）（分别为依那普利或缬沙坦）。自我报告种族的患者被分为白人、亚洲人或黑人。我们评估了各种族首次HF住院或心血管死亡的复合终点、其组成部分以及血管性水肿情况。
结果
在12097名参与者中，9451名（78.1%）为白人，2116名（17.5%）为亚洲人，530名（4.4%）为黑人。在中位随访2.5年期间，与白人患者相比，黑人（调整后HR：1.68；95%CI：1.42 - 1.98）和亚洲患者（调整后HR：1.32；95%CI：1.18 - 1.47）发生主要终点事件的风险更高。沙库巴曲缬沙坦与RASi对主要终点的治疗效果在白人（HR：0.84；95%CI：0.77 - 0.91）、亚洲人（HR：0.92；95%CI：0.78 - 1.10）和黑人患者中是一致的（HR：0.79；95%CI：0.58 - 1.07；P = 0.58）。与RASi相比，沙库巴曲缬沙坦导致的严重血管性水肿发生率更高（白人：0.2%对0.1%；黑人：1.5%对0.0%；亚洲人：0.1%对0.1%）。
结论
在两项全球试验的汇总经验中，黑人和亚洲患者发生心血管事件的风险高于白人患者。沙库巴曲缬沙坦的益处各种族一致。严重血管性水肿的风险较低，但沙库巴曲缬沙坦在数值上更高。（ARNI与ACEI对心力衰竭全球死亡率和发病率影响的前瞻性比较[PARADIGM-HF]；NCT01035255；ARNI与ARB对射血分数保留的心力衰竭全球结局的前瞻性比较[PARAGON-HF]；NCT01920711）
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