JACC: Heart Failure ( IF 10.3 ) Pub Date : 2019-10-09 , DOI: 10.1016/j.jchf.2019.07.011 Stephen J Greene 1 , Adam D DeVore 1 , Shubin Sheng 2 , Gregg C Fonarow 3 , Javed Butler 4 , Robert M Califf 5 , Adrian F Hernandez 1 , Roland A Matsouaka 2 , Ayman Samman Tahhan 6 , Kevin L Thomas 1 , Muthiah Vaduganathan 7 , Clyde W Yancy 8 , Eric D Peterson 1 , Christopher M O'Connor 9 , Robert J Mentz 1
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Objectives
This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
Background
Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
Methods
The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines–Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
Results
Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
Conclusions
Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852)
中文翻译：
按种族和性别划分的心力衰竭试验的代表性：ASCEND-HF 和 GWTG-HF 的结果。
目标
本研究旨在根据种族和性别确定参加心力衰竭 (HF) 试验的美国患者在多大程度上代表了美国常规临床实践中的患者。
背景
黑人患者和女性在 HF 临床试验中的代表性通常不足。然而，参与试验的黑人患者和女性在常规实践中代表此类患者的程度尚不清楚。
方法
ASCEND-HF（奈西立肽在失代偿性心力衰竭中的临床疗效的急性研究）试验从 2007 年 5 月至 2010 年 8 月将因 HF 住院的患者随机接受奈西立肽或安慰剂治疗，临床终点为中性。该分析比较了美国参加 ASCEND-HF 的非西班牙裔白人 (n = 1,494) 和黑人 (n = 1,012) 患者与美国住院 HF 登记处（即 Get With The Guidelines）中的非西班牙裔白人和黑人患者–心力衰竭 [GWTG-HF]）在 ASCEND-HF 注册期间并符合试验资格标准。
结果
在 79,291 名白人和黑人登记患者中，49,063 人 (62%) 符合试验资格标准（白人，n = 37,883 [77.2%]；黑人，n = 11,180 [22.8%]）。女性分别占 ASCEND-HF 和符合试验条件的 GWTG-HF 队列的 35% 和 49%。与参加试验的患者相比，符合试验条件的 GWTG-HF 患者往往年龄更大，血压和射血分数更高。与纳入试验的患者相比，符合试验条件的患者的住院死亡率（2.3% 对 1.3%）、30 天再入院（20.2% 对 16.8%）和 180 天死亡率（21.2% 对 18.6%）更高。试验（所有 p < 0.02），按种族和性别划分的死亡率结果一致。倾向得分匹配后，死亡率相似；然而，符合试验条件的患者的 30 天再入院率继续较高（23.1% 对 17.3%；p < 0.01），
结论
在美国实践中发现并符合 ASCEND-HF 试验条件的 HF 患者的临床结果比参加试验的患者差。在考虑了临床特征后，由于黑人患者和女性之间的差异，符合试验条件的现实世界患者的 30 天再入院率继续较高。社会、行为和其他未测量的因素可能会损害参加 HF 试验的患者的代表性，特别是在少数种族/族裔和女性中。（奈西立肽治疗失代偿性心力衰竭临床疗效的急性研究 [ASCEND-HF]；NCT00475852）
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