PDF(Pubmed)
Abstract：
Hospitalization is recognized as a sentinel event in the disease trajectory of patients with heart failure (HF), but not all patients experiencing clinical decompensation are ultimately hospitalized. Outpatient intensification of diuretics is common in response to symptoms of worsening HF, yet its prognostic and clinical relevance, specifically for patients with HF with mildly reduced or preserved ejection fraction, is uncertain.
In this prespecified analysis of the DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure), we assessed the association between various nonfatal worsening HF events (those requiring hospitalization, urgent outpatient visits requiring intravenous HF therapies, and outpatient oral diuretic intensification) and rates of subsequent mortality. We further examined the treatment effect of dapagliflozin on an expanded composite end point of cardiovascular death, HF hospitalization, urgent HF visit, or outpatient oral diuretic intensification.
In DELIVER, 4532 (72%) patients experienced no worsening HF event, whereas 789 (13%) had outpatient oral diuretic intensification, 86 (1%) required an urgent HF visit, 585 (9%) had an HF hospitalization, and 271 (4%) died of cardiovascular causes as a first presentation. Patients with a first presentation manifesting as outpatient oral diuretic intensification experienced rates of subsequent mortality that were higher (10 [8-12] per 100 patient-years) than those without a worsening HF event (4 [3-4] per 100 patient-years) but similar to rates of subsequent death after an urgent HF visit (10 [6-18] per 100 patient-years). Patients with an HF hospitalization as a first presentation of worsening HF had the highest rates of subsequent death (35 [31-40] per 100 patient-years). The addition of outpatient diuretic intensification to the adjudicated DELIVER primary end point (cardiovascular death, HF hospitalization, or urgent HF visit) increased the overall number of patients experiencing an event from 1122 to 1731 (a 54% increase). Dapagliflozin reduced the need for outpatient diuretic intensification alone (hazard ratio, 0.72 [95% CI, 0.64-0.82]) and when analyzed as a part of an expanded composite end point of worsening HF or cardiovascular death (hazard ratio, 0.76 [95% CI, 0.69-0.84]).
In patients with HF with mildly reduced or preserved ejection fraction, worsening HF requiring oral diuretic intensification in ambulatory care was frequent, adversely prognostic, and significantly reduced by dapagliflozin.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03619213.
In this prespecified analysis of the DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure), we assessed the association between various nonfatal worsening HF events (those requiring hospitalization, urgent outpatient visits requiring intravenous HF therapies, and outpatient oral diuretic intensification) and rates of subsequent mortality. We further examined the treatment effect of dapagliflozin on an expanded composite end point of cardiovascular death, HF hospitalization, urgent HF visit, or outpatient oral diuretic intensification.
In DELIVER, 4532 (72%) patients experienced no worsening HF event, whereas 789 (13%) had outpatient oral diuretic intensification, 86 (1%) required an urgent HF visit, 585 (9%) had an HF hospitalization, and 271 (4%) died of cardiovascular causes as a first presentation. Patients with a first presentation manifesting as outpatient oral diuretic intensification experienced rates of subsequent mortality that were higher (10 [8-12] per 100 patient-years) than those without a worsening HF event (4 [3-4] per 100 patient-years) but similar to rates of subsequent death after an urgent HF visit (10 [6-18] per 100 patient-years). Patients with an HF hospitalization as a first presentation of worsening HF had the highest rates of subsequent death (35 [31-40] per 100 patient-years). The addition of outpatient diuretic intensification to the adjudicated DELIVER primary end point (cardiovascular death, HF hospitalization, or urgent HF visit) increased the overall number of patients experiencing an event from 1122 to 1731 (a 54% increase). Dapagliflozin reduced the need for outpatient diuretic intensification alone (hazard ratio, 0.72 [95% CI, 0.64-0.82]) and when analyzed as a part of an expanded composite end point of worsening HF or cardiovascular death (hazard ratio, 0.76 [95% CI, 0.69-0.84]).
In patients with HF with mildly reduced or preserved ejection fraction, worsening HF requiring oral diuretic intensification in ambulatory care was frequent, adversely prognostic, and significantly reduced by dapagliflozin.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03619213.
摘要：
背景：住院被认为是心力衰竭（HF）患者疾病轨迹中的前哨事件，但并非所有临床代偿失调的患者最终都会住院。门诊加强利尿剂是常见的应对症状恶化的HF，然而其预后和临床相关性，特别是在射血分数轻度降低或保留的HF患者中，尚不确定。方法：在对DELIVER试验的预设分析中，我们评估了各种非致死性恶化HF事件(需要住院治疗的患者,需要静脉注射HF治疗的紧急门诊就诊，和门诊口服利尿剂强化）和随后的死亡率。我们进一步检查了达格列净对CV死亡的扩展复合终点的治疗效果，HF住院治疗，紧急HF访问,或门诊口服利尿剂强化。结果：在交付中，4,532例（72%）患者未出现恶化的HF事件，789人（13%）门诊口服利尿剂强化，86（1％）需要紧急HF访问，585（9％）有HF住院，和271（4％）死于CV原因作为第一次表现。首次表现为门诊口服利尿剂强化治疗的患者随后的死亡率(10[8-12]/100py)高于未出现恶化HF事件的患者(4[3-4]/100py),但与紧急HF就诊后的随后死亡率(10[6-18]/100py)相似。首次出现HF恶化的HF住院患者的后续死亡率最高（每100py35[31-40]）。在裁定的DELIVER主要终点（CV死亡，HF住院治疗，或紧急HF访视）使经历事件的患者总数从1,122增加到1,731（增加54％）。Dapagliflozin降低了单独门诊利尿剂强化的需求（HR0.72;95％CI：0.64-0.82），并且当分析为HF或CV死亡恶化的扩展复合终点的一部分时（HR0.76;95％CI：0.69-0.84）。结论：在轻度降低或保留射血分数的HF患者中，在门诊护理中需要口服利尿剂强化的HF恶化是常见的，预后不良，达格列净显著减少。
