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Randomized Controlled Trial
. 2019 Jan;26(1):41-50.
doi: 10.1111/acem.13504. Epub 2018 Jul 19.

The HEART Pathway Randomized Controlled Trial One-year Outcomes

Jason P Stopyra  1 , Robert F Riley  2 , Brian C Hiestand  1 , Gregory B Russell  3 , James W Hoekstra  1 , Cedric W Lefebvre  1 , Bret A Nicks  1 , David M Cline  1 , Kim L Askew  1 , Stephanie B Elliott  1 , David M Herrington  3 , Gregory L Burke  4   5 , Chadwick D Miller  1 , Simon A Mahler  1   6
Affiliations
Randomized Controlled Trial

The HEART Pathway Randomized Controlled Trial One-year Outcomes

Jason P Stopyra et al. Acad Emerg Med. 2019 Jan.

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.

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Figures

Figure 1.
Figure 1.
HEART Pathway algorithm. This figure was corrected on 2018–09-17 after initial online publication to correct the spelling of the label “HEART Score.”
Figure 2.
Figure 2.
HEART pathway RCT flow diagram. RCT = randomized controlled trial.
See this image and copyright information in PMC

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