Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom.
J Am Coll Cardiol. 2022 Oct 4;80(14):1302-1310. doi: 10.1016/j.jacc.2022.07.021. Epub 2022 Aug 27.
Patients recently hospitalized for heart failure (HF) are at high risk for rehospitalization and death.
The purpose of this study was to investigate clinical outcomes and response to dapagliflozin in patients with HF with mildly reduced or preserved left ventricular ejection fraction (LVEF) who were enrolled during or following hospitalization.
The DELIVER (Dapagliflozin Evaluation to Improve the LIVES of Patients With PReserved Ejection Fraction Heart Failure) trial randomized patients with HF and LVEF >40% to dapagliflozin or placebo. DELIVER permitted randomization during or shortly after hospitalization for HF in clinically stable patients off intravenous HF therapies. This prespecified analysis investigated whether recent HF hospitalization modified risk of clinical events or response to dapagliflozin. The primary outcome was worsening HF event or cardiovascular death.
Of 6,263 patients in DELIVER, 654 (10.4%) were randomized during HF hospitalization or within 30 days of discharge. Recent HF hospitalization was associated with greater risk of the primary outcome after multivariable adjustment (HR: 1.88; 95% CI: 1.60-2.21; P < 0.001). Dapagliflozin reduced the primary outcome by 22% in recently hospitalized patients (HR: 0.78; 95% CI: 0.60-1.03) and 18% in patients without recent hospitalization (HR: 0.82; 95% CI: 0.72-0.94; P = 0.71). Rates of adverse events, including volume depletion, diabetic ketoacidosis, or renal events, were similar with dapagliflozin and placebo in recently hospitalized patients.
Dapagliflozin safely reduced risk of worsening HF or cardiovascular death similarly in patients with and without history of recent HF hospitalization. Starting dapagliflozin during or shortly after HF hospitalization in patients with mildly reduced or preserved LVEF appears safe and effective. (Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure [DELIVER]; NCT03619213).
近期因心力衰竭（HF）住院的患者再住院和死亡风险较高。
本研究旨在探讨在住院期间或出院后入组的射血分数轻度降低或保留的心力衰竭（HF）患者中，达格列净的临床结局和疗效。
DELIVER（达格列净评估以改善射血分数保留心力衰竭患者的生活）试验将射血分数＞40%的 HF 患者随机分为达格列净或安慰剂组。DELIVER 允许在 HF 静脉治疗结束后临床稳定的患者住院或住院后不久进行随机分组。本预先设定的分析旨在探讨近期 HF 住院是否改变了临床事件的风险或对达格列净的反应。主要结局为 HF 恶化事件或心血管死亡。
在 DELIVER 试验的 6263 例患者中，有 654 例（10.4%）在 HF 住院期间或出院后 30 天内随机分组。多变量调整后，近期 HF 住院与主要结局风险增加相关（HR：1.88；95%CI：1.60-2.21；P＜0.001）。达格列净使近期住院患者的主要结局降低了 22%（HR：0.78；95%CI：0.60-1.03），使无近期住院史患者的主要结局降低了 18%（HR：0.82；95%CI：0.72-0.94；P=0.71）。在近期住院患者中，达格列净和安慰剂的不良事件（包括容量不足、糖尿病酮症酸中毒或肾脏事件）发生率相似。
达格列净在近期有或无 HF 住院史的患者中，安全且同样降低了 HF 恶化或心血管死亡的风险。在射血分数轻度降低或保留的 HF 患者住院期间或出院后不久开始使用达格列净似乎是安全有效的。（达格列净评估以改善射血分数保留心力衰竭患者的生活[DELIVER]；NCT03619213）。
