Department of Research & Evaluation Kaiser Permanente Southern California Pasadena CA.
Internal Medicine Kaiser Permanente Southern California Baldwin Park CA.
J Am Heart Assoc. 2022 Apr 5;11(7):e023766. doi: 10.1161/JAHA.121.023766. Epub 2022 Mar 24.
Background Randomized clinical trials in populations with heart failure with reduced ejection fraction may not be reflective of the general population with heart failure with reduced ejection fraction. Our study assessed the representativeness of the GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) patient population in Kaiser Permanente Southern California. Methods and Results We identified 9770 patients with a diagnosis of heart failure with reduced ejection fraction from 2014 to 2018 using electronic health records. Four mutually exclusive cohorts were created, including GALACTIC-HF-ineligible cohorts: (1) not taking guideline-directed medical therapy (GDMT) and (2) taking GDMT; and GALACTIC-HF-eligible cohorts with: (3) ejection fraction (EF) ≤28% and (4) EF 29% to 35%. Patients were followed for 30-day and 1-year mortality and 30-day, 180-day, and 1-year hospitalization. Overall, 3626 (37.1%) met GALACTIC-HF inclusion criteria with EF ≤35%, and 2367 (65.3%) of those individuals had EF ≤28%. The risk of 1-year mortality was lower among all cohorts versus the GALACTIC-HF-ineligible cohort not taking GDMT (hazard ratio, 0.80 [95% CI, 0.70-0.91], 0.84 [95% CI, 0.72-0.98], and 0.62 [95% CI, 0.51-0.75] for the GALACTIC-HF-ineligible cohort taking GDMT and GALACTIC-HF-eligible cohorts with EF ≤28% and 29%-35%, respectively). Compared with the GALACTIC-HF-ineligible cohort not taking GDMT, the short-term hospitalization risk at 30 and 180 days were similar for both GALACTIC-HF-eligible cohorts and the hospitalization risk at 1 year was similar for the GALACTIC-HF-eligible cohort with EF ≤28%. Conclusions A large portion of patients with heart failure with reduced ejection fraction with low EF met inclusion criteria for the GALACTIC-HF trial and, despite being on GDMT, had hospitalization rates similar to those not taking GDMT, suggesting potential benefits from other innovative treatments.
背景 针对射血分数降低的心力衰竭人群的随机临床试验可能无法反映射血分数降低的心力衰竭的一般人群情况。我们的研究评估了 Kaiser Permanente 南加州 GALACTIC-HF（通过改善心力衰竭收缩力降低不良心脏结局的全球方法）患者人群的代表性。
方法和结果 我们使用电子健康记录从 2014 年至 2018 年确定了 9770 例射血分数降低的心力衰竭诊断患者。创建了四个相互排斥的队列，包括 GALACTIC-HF 不合格队列：（1）未服用指南指导的药物治疗（GDMT）和（2）服用 GDMT；和 GALACTIC-HF 合格队列：（3）射血分数（EF）≤28%和（4）EF 29%至 35%。对患者进行了 30 天和 1 年死亡率以及 30 天、180 天和 1 年住院治疗的随访。总体而言，3626 例（37.1%）符合 EF≤35%的 GALACTIC-HF 纳入标准，其中 2367 例（65.3%）EF≤28%。与不服用 GDMT 的 GALACTIC-HF 不合格队列相比，所有队列的 1 年死亡率风险均较低（危险比分别为 0.80 [95%CI，0.70-0.91]、0.84 [95%CI，0.72-0.98]和 0.62 [95%CI，0.51-0.75]）、服用 GDMT 的 GALACTIC-HF 不合格队列和 EF≤28%和 29%-35%的 GALACTIC-HF 合格队列）。与不服用 GDMT 的 GALACTIC-HF 不合格队列相比，EF≤28%的 GALACTIC-HF 合格队列在 30 天和 180 天的短期住院风险相似，而在 1 年的住院风险相似。
结论 很大一部分射血分数降低且 EF 较低的心力衰竭患者符合 GALACTIC-HF 试验的纳入标准，尽管他们正在接受 GDMT，但住院率与未接受 GDMT 的患者相似，这表明其他创新治疗可能会带来益处。
