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Chew DP, Hyun K, Morton E, et al. Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial. JAMA Cardiol. 2021;6(3):304-313doi: 10.1001/jamacardio.2020.6314.
Chew, D. P., Hyun, K., Morton, E., Horsfall, M., Hillis, G. S., Chow, C. K., Quinn, S., D'Souza, M., Yan, A. T., Gale, C. P., Goodman, S. G., Fox, K., & Brieger, D. (2021). Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial. JAMA cardiology, 6(3), 304-313. https://doi.org/10.1001/jamacardio.2020.6314
Chew, Derek P, et al. "Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial." JAMA cardiology vol. 6,3 (2021): 304-313. doi: https://doi.org/10.1001/jamacardio.2020.6314
Chew DP, Hyun K, Morton E, Horsfall M, Hillis GS, Chow CK, Quinn S, D'Souza M, Yan AT, Gale CP, Goodman SG, Fox K, Brieger D. Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial. JAMA Cardiol. 2021 Mar 01;6(3):304-313. doi: 10.1001/jamacardio.2020.6314. PMID: 33295965; PMCID: PMC7726696.
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JAMA Cardiol. 2021 Mar 01;6(3):304-313. doi: 10.1001/jamacardio.2020.6314.

Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial.

JAMA cardiology

Derek P Chew, Karice Hyun, Erin Morton, Matt Horsfall, Graham S Hillis, Clara K Chow, Stephen Quinn, Mario D'Souza, Andrew T Yan, Chris P Gale, Shaun G Goodman, Keith Fox, David Brieger

Affiliations

  1. College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia.
  2. Westmead Applied Research Centre, Faulty of Medicine and Health, University of Sydney, Sydney, Australia.
  3. Department of Cardiology, Westmead Hospital, Sydney, Australia.
  4. School of Medicine, University of Western Australia, Perth, Australia.
  5. Department of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Australia.
  6. St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
  7. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, England.
  8. Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland.
  9. Cardiology Department, Concord Repatriation General Hospital, Sydney, Australia.

PMID: 33295965 PMCID: PMC7726696 DOI: 10.1001/jamacardio.2020.6314

Abstract

IMPORTANCE: Although international guidelines recommend use of the Global Registries of Acute Coronary Events (GRACE) risk score (GRS) to guide acute coronary syndrome (ACS) treatment decisions, the prospective utility of the GRS in improving care and outcomes is unproven.

OBJECTIVE: To assess the effect of routine GRS implementation on guideline-indicated treatments and clinical outcomes of hospitalized patients with ACS.

DESIGN, SETTING, AND PARTICIPANTS: Prospective cluster (hospital-level) randomized open-label blinded end point (PROBE) clinical trial using a multicenter ACS registry of acute care cardiology services. Fixed sampling of the first 10 patients within calendar month, with either ST-segment elevation or non-ST-segment elevation ACS. The study enrolled patients from June 2014 to March 2018, and data were analyzed between February 2020 and April 2020.

INTERVENTIONS: Implementation of routine risk stratification using the GRS and guideline recommendations.

MAIN OUTCOMES AND MEASURES: The primary outcome was a performance score based on receipt of early invasive treatment, discharge prescription of 4 of 5 guideline-recommended pharmacotherapies, and cardiac rehabilitation referral. Clinical outcomes included a composite of all-cause death and/or myocardial infarction (MI) within 1 year.

RESULTS: This study enrolled 2318 patients from 24 hospitals and was stopped prematurely owing to futility. Of the patients enrolled, median age was 65 years (interquartile range, 56-74 years), 29.5% were women (n = 684), and 62.9% were considered high risk (n = 1433). Provision of all 3 measures among high-risk patients did not differ between the randomized arms (GRS: 424 of 717 [59.9%] vs control: 376 of 681 [55.2%]; odds ratio [OR], 1.04; 95% CI, 0.63-1.71; P = .88). The provision of early invasive treatment was increased compared with the control arm (GRS: 1042 of 1135 [91.8%] vs control: 989 of 1183 [83.6%]; OR, 2.26; 95% CI, 1.30-3.96; P = .004). Prescription of 4 of 5 guideline-recommended pharmacotherapies (GRS: 864 of 1135 [76.7%] vs control: 893 of 1183 [77.5%]; OR, 0.97; 95% CI, 0.68-1.38) and cardiac rehabilitation (GRS: 855 of 1135 [75.1%] vs control: 861 of 1183 [72.8%]; OR, 0.68; 95% CI, 0.32-1.44) were not different. By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14).

CONCLUSIONS AND RELEVANCE: Routine GRS implementation in cardiology services with high levels of clinical care was associated with an increase in early invasive treatment but not other aspects of care. Low event rates and premature study discontinuation indicates the need for further, larger scale randomized studies.

TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12614000550606.

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