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HEART 路径随机对照试验一年期结果。

The HEART Pathway Randomized Controlled Trial One-year Outcomes.

机构信息

Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, NC.

The Christ Hospital Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH.

出版信息

Acad Emerg Med. 2019 Jan;26(1):41-50. doi: 10.1111/acem.13504. Epub 2018 Jul 19.

Abstract

OBJECTIVE

The objective was to determine the impact of the HEART Pathway on health care utilization and safety outcomes at 1 year in patients with acute chest pain.

METHODS

Adult emergency department (ED) patients with chest pain (N = 282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, ED providers used the HEART score and troponin measures (0 and 3 hours) to risk stratify patients. Usual care was based on American College of Cardiology/American Heart Association guidelines. Major adverse cardiac events (MACE-cardiac death, myocardial infarction [MI], or coronary revascularization), objective testing (stress testing or coronary angiography), and cardiac hospitalizations and ED visits were assessed at 1 year. Randomization arm outcomes were compared using Fisher's exact tests.

RESULTS

A total of 282 patients were enrolled, with 141 randomized to each arm. MACE at 1 year occurred in 10.6% (30/282): 9.9% in the HEART Pathway arm (14/141; 10 MIs, four revascularizations without MI) versus 11.3% in usual care (16/141; one cardiac death, 13 MIs, two revascularizations without MI; p = 0.85). Among low-risk HEART Pathway patients, 0% (0/66) had MACE, with a negative predictive value (NPV) of 100% (95% confidence interval = 93%-100%). Objective testing through 1 year occurred in 63.1% (89/141) of HEART Pathway patients compared to 71.6% (101/141) in usual care (p = 0.16). Nonindex cardiac-related hospitalizations and ED visits occurred in 14.9% (21/141) and 21.3% (30/141) of patients in the HEART Pathway versus 10.6% (15/141) and 16.3% (23/141) in usual care (p = 0.37, p = 0.36).

CONCLUSIONS

The HEART Pathway had a 100% NPV for 1-year safety outcomes (MACE) without increasing downstream hospitalizations or ED visits. Reduction in 1-year objective testing was not significant.

摘要

目的

确定 HEART 路径对急性胸痛患者 1 年时的医疗保健利用和安全结局的影响。

方法

对 282 例胸痛的成年急诊(ED)患者进行随机分组,分别接受 HEART 路径或常规护理。在 HEART 路径组中,ED 提供者使用 HEART 评分和肌钙蛋白测量(0 小时和 3 小时)对患者进行风险分层。常规护理基于美国心脏病学会/美国心脏协会指南。主要不良心脏事件(MACE-心脏死亡、心肌梗死[MI]或冠状动脉血运重建)、客观检查(压力检查或冠状动脉造影)以及心脏住院和 ED 就诊在 1 年内进行评估。使用 Fisher 精确检验比较随机分组结果。

结果

共纳入 282 例患者,每组 141 例。1 年时 MACE 发生率为 10.6%(30/282):HEART 路径组为 9.9%(14/141;10 例 MI,4 例无 MI 的血运重建),常规护理组为 11.3%(16/141;1 例心脏死亡,13 例 MI,2 例无 MI 的血运重建;p=0.85)。在低危 HEART 路径患者中,0%(0/66)发生 MACE,阴性预测值(NPV)为 100%(95%置信区间=93%-100%)。与常规护理组(71.6%[101/141])相比,HEART 路径组在 1 年内进行客观检查的患者比例为 63.1%(89/141)(p=0.16)。在 HEART 路径组,非索引性心脏相关住院和 ED 就诊的患者比例分别为 14.9%(21/141)和 21.3%(30/141),而在常规护理组分别为 10.6%(15/141)和 16.3%(23/141)(p=0.37,p=0.36)。

结论

HEART 路径对 1 年安全性结局(MACE)的 NPV 为 100%,且不会增加下游的住院和 ED 就诊。1 年内客观检查的减少并不显著。

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