加拿大多伦多大学Douglas S. Lee团队进行了改善急性心力衰竭预后的干预试验。相关论文于2022年11月5日发表在《新英格兰医学杂志》上。

急性心力衰竭患者经常或系统地住院治疗，通常是因为不良事件风险不确定，快速随访的选择也不充分。使用某种策略来支持临床医生做出出院或收治患者的决定，再加上门诊的快速随访，是否会影响结局仍不确定。

研究组在加拿大安大略省进行了一项阶梯楔形、群集随机试验，将10家医院随机分配到交错的开始日期，从对照阶段（常规护理）到干预阶段进行单向交叉，这涉及使用护理点算法根据死亡风险对急性心力衰竭患者进行分层。在干预阶段，低风险患者提前出院（≤3天），并接受标准化门诊护理，高风险患者入住医院。共同主要结局是发病后30天内全因死亡或因心血管原因住院的综合结局和20个月内的综合结局。

共有5452名患者入组（对照期2972名，干预期2480名）。在30天内，干预阶段组中有301名患者（12.1%）全因死亡或因心血管原因住院，对照阶段组中有430名患者（14.5%），校正后的危险比为0.88，组间差异显著。在20个月内，在干预阶段入组的患者中，主要结局事件的累计发生率为54.4%，在对照阶段入组的患者中为56.2%，校正后的危险比为0.95。在出院后30天内首次门诊就诊前，低风险或中风险患者全因死亡或住院的人数少于6人。

研究结果表明，在寻求紧急护理的急性心力衰竭患者中，使用基于医院的策略来支持临床决策和快速随访，导致30天内全因死亡或因心血管原因住院的复合风险低于常规护理。

附：英文原文

Title: Trial of an Intervention to Improve Acute Heart Failure Outcomes | NEJM

Author: Douglas S. Lee, M.D., Ph.D.,, Sharon E. Straus, M.D.,, Michael E. Farkouh, M.D.,, Peter C. Austin, Ph.D.,, Monica Taljaard, Ph.D.,, Alice Chong, B.Sc.,, Christine Fahim, Ph.D.,, Stephanie Poon, M.D.,, Peter Cram, M.D.,, Stuart Smith, M.D.,, Robert S. McKelvie, M.D., Ph.D.,, Liane Porepa, M.D.,, Michael Hartleib, M.D.,, Peter Mitoff, M.D.,, Robert M. Iwanochko, M.D.,, Andrea MacDougall, M.D.,, Steven Shadowitz, M.D., C.M.,, Howard Abrams, M.D.,, Esam Elbarasi, M.B., Ch.B.,, Jiming Fang, Ph.D.,, Jacob A. Udell, M.D., M.P.H.,, Michael J. Schull, M.D.,, Susanna Mak, M.D., Ph.D.,, and Heather J. Ross, M.D., M.H.Sc.

Issue&Volume: 2022-11-05

Abstract:

Background

Patients with acute heart failure are frequently or systematically hospitalized, often because the risk of adverse events is uncertain and the options for rapid follow-up are inadequate. Whether the use of a strategy to support clinicians in making decisions about discharging or admitting patients, coupled with rapid follow-up in an outpatient clinic, would affect outcomes remains uncertain.

Methods

In a stepped-wedge, cluster-randomized trial conducted in Ontario, Canada, we randomly assigned 10 hospitals to staggered start dates for one-way crossover from the control phase (usual care) to the intervention phase, which involved the use of a point-of-care algorithm to stratify patients with acute heart failure according to the risk of death. During the intervention phase, low-risk patients were discharged early (in ≤3 days) and received standardized outpatient care, and high-risk patients were admitted to the hospital. The coprimary outcomes were a composite of death from any cause or hospitalization for cardiovascular causes within 30 days after presentation and the composite outcome within 20 months.

Results

A total of 5452 patients were enrolled in the trial (2972 during the control phase and 2480 during the intervention phase). Within 30 days, death from any cause or hospitalization for cardiovascular causes occurred in 301 patients (12.1%) who were enrolled during the intervention phase and in 430 patients (14.5%) who were enrolled during the control phase (adjusted hazard ratio, 0.88; 95% confidence interval [CI], 0.78 to 0.99; P=0.04). Within 20 months, the cumulative incidence of primary-outcome events was 54.4% (95% CI, 48.6 to 59.9) among patients who were enrolled during the intervention phase and 56.2% (95% CI, 54.2 to 58.1) among patients who were enrolled during the control phase (adjusted hazard ratio, 0.95; 95% CI, 0.92 to 0.99). Fewer than six deaths or hospitalizations for any cause occurred in low- or intermediate-risk patients before the first outpatient visit within 30 days after discharge.

Conclusions

Among patients with acute heart failure who were seeking emergency care, the use of a hospital-based strategy to support clinical decision making and rapid follow-up led to a lower risk of the composite of death from any cause or hospitalization for cardiovascular causes within 30 days than usual care.

DOI: 10.1056/NEJMoa2211680

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2211680