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Randomized Controlled Trial
. 2021 Mar 1;6(3):304-313.
doi: 10.1001/jamacardio.2020.6314.

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

Derek P Chew  1 , Karice Hyun  2   3 , Erin Morton  1 , Matt Horsfall  1 , Graham S Hillis  4 , Clara K Chow  2 , Stephen Quinn  5 , Mario D'Souza  2 , Andrew T Yan  6 , Chris P Gale  7 , Shaun G Goodman  6 , Keith Fox  8 , David Brieger  9
Affiliations
Randomized Controlled Trial

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

Derek P Chew et al. JAMA Cardiol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Chew reported grants from AstraZeneca during the conduct of the study and outside the submitted work and grants from Edwards Life Sciences outside the submitted work. Dr Morton reported grants from National Health and Medical Research Council (Australia) during the conduct of the study; other support from Roche and Flinders University outside the submitted work. Dr Chow reported grants from National Health and Medical Research Council (Australia) during the conduct of the study. Dr Yan reported grants from AstraZeneca outside the submitted work. Dr Gale reported personal fees from AstraZeneca, Bayer, Daiichi Sankyo, and Vifor Pharma and grants from Abbott BMS/Pfizer outside the submitted work. Dr Goodman reported grants and personal fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Novartis, and Sanofi and personal fees from CSL Behring, Daiichi Sankyo/American Regenet, Eli Lilly, Esperion, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, NovoNordisk A/C, Pfizer, Regeneron, and Servier outside the submitted work. Dr Fox reported grants and personal fees from Bayer/Janssen, grants from AstraZeneca, and personal fees from Sanofi/Regeneron and Verseon outside the submitted work. Dr Brieger reported grants from AstraZeneca during the conduct of the study; grants from Sanofi Aventis outside the submitted work; and personal fees from Aspen Pharmaceuticals and Pfizer/BMS outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Figure
CONCORDANCE indicates Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events; IQR, interquartile range.
Figure 2.
Figure 2.. Patient Subgroups Analysis for Compliance Measured as Compliance With All 3 Guideline Recommendations and Provision of Early Angiography
NSTEMI indicates non–ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction.
See this image and copyright information in PMC

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