Lee Douglas S, Straus Sharon E, Farkouh Michael E, Austin Peter C, Taljaard Monica, Chong Alice, Fahim Christine, Poon Stephanie, Cram Peter, Smith Stuart, McKelvie Robert S, Porepa Liane, Hartleib Michael, Mitoff Peter, Iwanochko Robert M, MacDougall Andrea, Shadowitz Steven, Abrams Howard, Elbarasi Esam, Fang Jiming, Udell Jacob A, Schull Michael J, Mak Susanna, Ross Heather J
From the University of Toronto (D.S.L., S.E.S., M.E.F., P.C.A., S.P., P.C., R.M.I., S. Shadowitz, H.A., J.A.U., M.J.S., S.M., H.J.R.), the Ted Rogers Centre for Heart Research and the Peter Munk Cardiac Centre, University Health Network (D.S.L., M.E.F., J.A.U., H.J.R.), ICES (formerly the Institute for Clinical Evaluative Sciences) (D.S.L., P.C.A., A.C., P.C., J.F., J.A.U., M.J.S.), St. Michael's Hospital and Li Ka Shing Knowledge Institute, Unity Health (S.E.S., C.F.), the Divisions of Cardiology (S.P.) and General Internal Medicine (S. Shadowitz) and the Department of Emergency Services and Sunnybrook Research Institute (M.J.S.), Sunnybrook Health Sciences Centre, the Division of Cardiology, St. Joseph's Hospital (P.M.), the Division of Cardiology, Toronto Western Hospital (R.M.I.), the Division of General Internal Medicine, Toronto General Hospital (H.A.), the Division of Cardiology, Women's College Hospital (J.A.U.), and the Division of Cardiology, Sinai Health (S.M.), Toronto, the Clinical Epidemiology Program, Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa (M.T.), the Division of Cardiology, London Health Sciences Centre (S. Smith), Western University (S. Smith, R.S.M.), and the Division of Cardiology, St. Joseph's Health Care (R.S.M.), London, the Division of Cardiology, Southlake Regional Health Centre, Newmarket (L.P.), the Division of Cardiology, Peterborough Regional Health Centre, Peterborough (M.H.), the Division of Cardiology, Thunder Bay Regional Health Sciences Centre, Thunder Bay (A.M.), and the Division of Cardiology, William Osler Health System, Brampton (E.E.) - all in Ontario, Canada; and the Department of Medicine, University of Texas Medical Branch, Galveston (P.C.).
N Engl J Med. 2023 Jan 5;388(1):22-32. doi: 10.1056/NEJMoa2211680. Epub 2022 Nov 5.
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.
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.
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.
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. (Funded by the Ontario SPOR Support Unit and others; COACH ClinicalTrials.gov number, NCT02674438.).
急性心力衰竭患者经常或系统性地住院治疗，通常是因为不良事件风险不确定且快速随访的选择不足。采用一种策略来支持临床医生做出出院或入院决策，并在门诊进行快速随访，是否会影响治疗结果仍不确定。
在加拿大安大略省进行的一项阶梯式楔形整群随机试验中，我们将10家医院随机分配到不同的起始日期，以进行从对照阶段（常规治疗）到干预阶段的单向交叉，干预阶段使用即时护理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，高风险患者则入院治疗。共同主要结局是就诊后30天内任何原因导致的死亡或心血管原因住院的复合结局以及20个月内的复合结局。
共有5452例患者纳入试验（对照阶段2972例，干预阶段2480例）。在30天内，干预阶段纳入的301例患者（12.1%）和对照阶段纳入的430例患者（14.5%）发生了任何原因导致的死亡或心血管原因住院（调整后风险比为0.88；95%置信区间[CI]为0.78至0.99；P = 0.04）。在20个月内，干预阶段纳入的患者中主要结局事件的累积发生率为54.4%（95%CI为48.6至59.9），对照阶段纳入的患者中为56.2%（95%CI为54.2至58.1）（调整后风险比为0.95；95%CI为0.92至0.99）。低风险或中度风险患者在出院后30天内首次门诊就诊前因任何原因死亡或住院的情况少于6例。
在寻求急诊治疗的急性心力衰竭患者中，采用基于医院的策略支持临床决策和快速随访，与常规治疗相比，可降低30天内任何原因导致的死亡或心血管原因住院复合结局的风险。（由安大略省SPOR支持单位等资助；COACH临床试验注册号，NCT02674438。）
