种族差异对射血分数保留心衰治疗试验中射血分数保留心衰患者特征和结局的影响。
Racial Differences in Characteristics and Outcomes of Patients With Heart Failure and Preserved Ejection Fraction in the Treatment of Preserved Cardiac Function Heart Failure Trial.
机构信息
From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (E.F.L., B.C., A.M.S., J.L., A.S.D., S.D.S., M.A.P.); Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.); Veterans Affairs Medical Center Minneapolis, Minnesota (I.A.); University of Minnesota Medical School, Minneapolis (I.A.); Veterans Affairs Medical Center at San Diego, CA (I.A.); Montreal Heart Institute, Quebec, Canada (J.L.R., E.O.); Department of Medicine, Sarver Heart Center, University of Arizona, Tucson (N.K.S.); Division of Cardiology, University of Utah, Salt Lake City (J.C.F.); Department of Medicine, Howard University College of Medicine, Washington, DC (T.M.R.); Division of Cardiology, New York Methodist Hospital, Brooklyn (J.F.H.); Division of Cardiology, University of Illinois at Chicago (T.D.S.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B.); and University of Michigan School of Medicine, Ann Arbor (B.P.).
出版信息
Circ Heart Fail. 2018 Mar;11(3):e004457. doi: 10.1161/CIRCHEARTFAILURE.117.004457.
BACKGROUND
Black patients have been shown to have different baseline characteristics and outcomes compared with nonblack patients in cohort studies. However, few studies have focused on heart failure (HF) with preserved ejection fraction (HFpEF) patients. We aimed to determine the difference in cardiovascular outcomes in black and nonblack patients with HFpEF and to determine the relative efficacy and safety of spironolactone in black and nonblack patients.
METHODS AND RESULTS
Patients with HFpEF, randomized to spironolactone versus placebo in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) in North and South America, were grouped according to self-described black and nonblack race. Black HFpEF patients (n=302) were younger and were more likely to have diabetes mellitus and hypertension than nonblack patients but had similar HFpEF severity. Black patients had higher risk for the primary outcome (hazard ratio [HR], 1.34; 95% confidence interval, 1.06-1.71; =0.02) and first HF hospitalization (HR, 1.51; 95% confidence interval, 1.167-1.97; =0.002)], but no significant difference in cardiovascular mortality risk (HR, 0.78; 95% confidence interval, 0.51-1.20; =0.326). In black and nonblack patients, randomization to spironolactone conferred similar efficacy in the primary outcome (HR, 0.83 versus 0.79; for interaction=0.49), HF hospitalization (HR, 0.67 versus 0.82; for interaction=0.76), and cardiovascular mortality ( for interaction=0.19). The risk of hyperkalemia and worsening renal function with spironolactone and study drug adherence were also similar.
CONCLUSIONS
Black patients with HFpEF have a higher HF hospitalization risk than nonblack patients, but spironolactone is similarly effective and safe in both groups.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00094302.
背景
队列研究表明，与非黑人患者相比，黑人患者的基线特征和结局存在差异。然而，很少有研究关注射血分数保留的心力衰竭（HFpEF）患者。我们旨在确定 HFpEF 黑人患者和非黑人患者心血管结局的差异，并确定螺内酯在黑人患者和非黑人患者中的相对疗效和安全性。
方法和结果
在北美和南美进行的 TOPCAT 试验（醛固酮拮抗剂治疗保留射血分数的心力衰竭）中，随机分配至螺内酯或安慰剂的 HFpEF 患者根据自我描述的黑人和非黑人种族进行分组。黑人 HFpEF 患者（n=302）较年轻，且更可能患有糖尿病和高血压，但 HFpEF 严重程度相似。黑人患者发生主要结局的风险更高（风险比[HR]，1.34；95%置信区间，1.06-1.71；=0.02）和首次 HF 住院（HR，1.51；95%置信区间，1.167-1.97；=0.002），但心血管死亡率风险无显著差异（HR，0.78；95%置信区间，0.51-1.20；=0.326）。在黑人患者和非黑人患者中，螺内酯随机分组在主要结局（HR，0.83 与 0.79；交互作用=0.49）、HF 住院（HR，0.67 与 0.82；交互作用=0.76）和心血管死亡率（交互作用=0.19）方面具有相似的疗效。螺内酯和研究药物依从性致高钾血症和肾功能恶化的风险也相似。
结论
HFpEF 的黑人患者 HF 住院风险高于非黑人患者，但螺内酯在两组中的疗效和安全性相似。
Zotero 插件