患者特征、临床结局以及达格列净与心力衰竭持续时间的关系：开始新的治疗是否为时过晚？
Patient Characteristics, Clinical Outcomes, and Effect of Dapagliflozin in Relation to Duration of Heart Failure: Is It Ever Too Late to Start a New Therapy?
机构信息
BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (S.E.Y., P.D., P.S.J., J.J.V.M.).
Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).
出版信息
Circ Heart Fail. 2020 Dec;13(12):e007879. doi: 10.1161/CIRCHEARTFAILURE.120.007879. Epub 2020 Nov 9.
BACKGROUND
The impact of heart failure (HF) duration on outcomes and treatment effect is largely unknown. We aim to compare baseline patient characteristics, outcomes, and the efficacy and safety of dapagliflozin, in relation to time from diagnosis of HF in DAPA-HF trial (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure).
METHODS
HF duration was categorized as ≥2 to ≤12 months, >1 to 2 years, >2 to 5 years, and >5 years. Outcomes were adjusted for prognostic variables and analyzed using Cox regression. The primary end point was the composite of worsening HF or cardiovascular death. Treatment effect was examined within each duration category and by duration threshold.
RESULTS
The number of patients in each category was: 1098 (≥2-≤12 months), 686 (>1-2 years), 1105 (>2-5 years), and 1855 (>5 years). Longer-duration HF patients were older and more comorbid with worse symptoms. The rate of the primary outcome (per 100 person-years) increased with HF duration: 10.2 (95% CI, 8.7-12.0) for ≥2 to ≤12 months, 10.6 (8.7-12.9) >1 to 2 years, 15.5 (13.6-17.7) >2 to 5 years, and 15.9 (14.5-17.6) for >5 years. Similar trends were seen for all other outcomes. The benefit of dapagliflozin was consistent across HF duration and on threshold analysis. The hazard ratio for the primary outcome ≥2 to ≤12 months was 0.86 (0.63-1.18), >1 to 2 years 0.95 (0.64-1.42), >2 to 5 years 0.74 (0.57-0.96), and >5 years 0.64 (0.53-0.78), interaction=0.26. The absolute benefit was greatest in longest-duration HF, with a number needed to treat of 18 for HF >5 years, compared with 28 for ≥2 to ≤12 months.
CONCLUSIONS
Longer-duration HF patients were older, had more comorbidity and symptoms, and higher rates of worsening HF and death. The benefits of dapagliflozin were consistent across HF duration. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03036124.
背景
心力衰竭（HF）持续时间对结局和治疗效果的影响在很大程度上尚不清楚。我们旨在比较 DAPA-HF 试验（达格列净预防心力衰竭不良结局）中与 HF 诊断时间相关的基线患者特征、结局以及达格列净的疗效和安全性。
方法
HF 持续时间分为≥2 至≤12 个月、>1 至 2 年、>2 至 5 年和>5 年。使用 Cox 回归分析对预后变量进行调整，并对结局进行分析。主要终点是 HF 恶化或心血管死亡的复合终点。在每个持续时间类别和通过持续时间阈值检查治疗效果。
结果
每个类别中的患者数量为：1098 例（≥2-≤12 个月）、686 例（>1-2 年）、1105 例（>2-5 年）和 1855 例（>5 年）。HF 持续时间较长的患者年龄较大，合并症更多，症状更严重。主要结局（每 100 人年发生率）随 HF 持续时间而增加：≥2-≤12 个月为 10.2（95%CI，8.7-12.0），>1-2 年为 10.6（8.7-12.9），>2-5 年为 15.5（13.6-17.7），>5 年为 15.9（14.5-17.6）。所有其他结局也出现了类似的趋势。达格列净的获益在 HF 持续时间内和在阈值分析中均一致。主要结局≥2-≤12 个月的风险比为 0.86（0.63-1.18），>1-2 年为 0.95（0.64-1.42），>2-5 年为 0.74（0.57-0.96），>5 年为 0.64（0.53-0.78），交互检验=0.26。HF 持续时间最长的患者获益最大，HF>5 年的需要治疗数为 18，而≥2-≤12 个月的需要治疗数为 28。
结论
HF 持续时间较长的患者年龄较大，合并症和症状更多，HF 恶化和死亡的发生率更高。达格列净的获益在 HF 持续时间内是一致的。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT03036124。
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