Article Text
Abstract
Objective The European Society of Cardiology (ESC) 0/1 hour algorithm has been primarily validated in Europe, America and Australasia with less knowledge of its performance outside of these settings. We aim to evaluate the performance of the ESC 0/1 hour algorithm across different contexts.
Methods We searched PubMed, Embase, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials for relevant studies published between 1 January 2008 and 31 May 2019. The primary outcome was index myocardial infarction and the secondary outcome was major adverse cardiac event or mortality. A bivariate random-effects meta-analysis was used to derive the pooled estimate of each outcome.
Results A total of 11 014 patients from 10 cohorts were analysed for the primary outcome. The algorithm based on high-sensitivity cardiac troponin (hs-cTn)T (Roche), hs-cTnI (Abbott) and hs-cTnI (Siemens) had pooled sensitivity of 98.4% (95% CI=95.1% to 99.5%), 98.1% (95% CI=94.6% to 99.3%) and 98.7% (95% CI=97.3% to 99.3%), respectively. The algorithm based on hs-cTnT (Roche) and hs-cTnI (Siemens) had pooled specificity of 91.2% (95% CI=86.0% to 94.6%) and 95.9% (95% CI=94.1% to 97.2%), respectively. Among patients in the rule-out category, the pooled mortality rate at 30 days and at 1 year was 0.1% (95% CI=0.0% to 0.4%) and 0.8% (95% CI=0.5% to 1.2%), respectively. Among patients in the observation zone, the pooled mortality rate was 0.7% (95% CI=0.3% to 1.2%) at 30 days but increased to 8.1% (95% CI=6.1% to 10.4%) at 1 year, comparable to the mortality rate in the rule-in group.
Conclusion The ESC 0/1 hour algorithm has high diagnostic accuracy but may not be sufficiently safe if the 1% miss-rate for myocardial infarction is desired.
PROSPERO registration number CRD42019142280.
- acute myocardial infarction
- acute coronary syndromes
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Footnotes
C-HC, C-HC and GHL contributed equally.
Contributors Study concept and design: C-CL and C-HC. Acquisition of data: C-HC, C-HC and GHL. Analysis of data: W-TG and Y-KW. Statistical advice: S-SH and YHY. Drafting of the manuscript: C-CL, C-HC, C-HC and GHL. Critical revision of the manuscript for important intellectual content: W-TG, Y-KW, S-SH, YHY and EG. Study supervision: C-CL and EG.
Funding This work was supported by a research grant from Taiwan National Ministry of Science and Technology Grants MOST 104-2314-B-002 -039 -MY3 and MOST 105-2811-B-002-031.
Competing interests EG reports personal fees from Roche Diagnostics, personal fees from Hoffmann La Roche, personal fees from Brahms Thermo Fischer, personal fees from Daiichi Sankyo, personal fees from Astra Zeneca and personal fees from Bayer Vital outside the submitted work. C-CL reports receiving speaking honorarium from Roche Diagnostics. All other authors report no conflict of interest.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.