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Study confirms safety of rapid algorithm to rule-out and rule-in myocardial infarction



Barcelona, Spain – 27 Aug 2017: The safety and efficacy of a rapid algorithm to rule-out and rule-in myocardial infarction has been confirmed in a study presented at ESC Congress today. (1)

Patients with symptoms suggestive of acute myocardial infarction (AMI) account for about 10% of all emergency department consultations. Rapid identification of AMI, which may be life-threatening, allows the early initiation of evidence-based therapy. Rapid and safe rule-out of AMI allows the timely detection and treatment of alternative causes of acute chest pain – many of which are benign, in which case patients can be reassured and sent home.

ESC guidelines recommend a 0/1-hour algorithm for patients with suspected non-ST-elevation myocardial infarction (NSTEMI). (2) Decisions are made using high-sensitivity cardiac troponin (hs-cTn) blood concentrations at presentation and one hour, in conjunction with clinical assessment and an electrocardiogram (ECG). This allows for quicker triage than the previous 0/3-hour algorithm, but there have been questions about the safety of the new procedure.

This study evaluated the diagnostic performance of the 0/1-hour algorithm using hs-cTnT and hs-cTnI. The study used pooled patient-level data from the prospective APACE and BACC studies.(3) A total of 4 350 patients presenting with acute chest pain to the emergency departments of 14 hospitals in six European countries were included.

Hs-cTnT and hs-cTnI blood concentrations were measured at presentation and after one hour. Safety of the algorithm was quantified by the negative predictive value for rule-out of NSTEMI. Performance of the 0/1-hour hs-cTn rule-in, which aims to identify patients eligible for early coronary angiography, was quantified by the positive predictive value for NSTEMI. Efficacy of the algorithm was quantified by the proportion of patients triaged to either rule-out or rule-in.

NSTEMI was the final diagnosis in 17% of patients. Safety of the 0/1-hour algorithm was very high with both hs-cTn assays: negative predictive values for NSTEMI were 99.8% using hs-cTnT and 99.6% using hs-cTnI. Rule-in performance was good, with a positive predictive value of 74.7% using hs-cTnT and 64.2% using hs-cTnI. Efficacy was very high, with more than two-thirds of patients assigned to either rule-out or rule-in.

Results were similar for the clinically challenging subgroup of patients presenting early (less than three hours) after chest pain onset, with negative predictive values of 99.5% and 99.2% for hs-cTnT and hs-cTnI assays, respectively.

“With this large multicentre analysis using central adjudication we were able to address concerns regarding the suitability of the 0/1-hour algorithm for routine clinical care,” said lead author Dr Raphael Twerenbold, senior researcher and cardiology fellow in the Cardiovascular Research Institute Basel, Switzerland. “We found that the algorithm, using either assay, was safe and effective in triaging patients with suspected acute myocardial infarction. Of note, safety was also excellent in the largest ever tested population of patients presenting within the first three hours after chest pain onset.”

Prof Christian Mueller, last author and director of the Cardiovascular Research Institute Basel, concluded: “These findings are of immediate and critical clinical relevance as many institutions worldwide are considering switching to the implementation of an accelerated, high-sensitivity cardiac troponin-based diagnostic protocol such as the 0/1-hour algorithm recommended by the ESC.”

ENDS

Notes to editor

Sources of funding: The APACE study was supported by research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel; Abbott, Beckman Coulter, Biomerieux, Brahms, Roche, Siemens, and Singulex. The BACC study was supported by the German Center of Cardiovascular Research and an unrestricted grant from Abbott Diagnostics. The investigated high-sensitivity cardiac troponin T and I assays were donated by Roche and Abbott, who had no role in the design of the study, the analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication.

Disclosures: Dr Twerenbold reports receiving research support from the Swiss National Science Foundation (P300PB-167803/1) and speaker honoraria/consulting honoraria from Roche Diagnostics, Abbott Diagnostics, Siemens and Brahms. Dr. Mueller reports receiving research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel; Abbott, Alere, Astra Zeneca, Beckman Coulter, Biomerieux, Brahms, Roche, Siemens, Singulex, Sphingotec, and the Department of Internal Medicine, University Hospital Basel, as well as speaker honoraria/consulting honoraria from Abbott, Alere, Astra Zeneca, Biomerieux, Boehringer Ingelheim, BMS, Brahms, Cardiorentis, Novartis, Roche, Siemens, and Singulex.
Dr Twerenbold reports receiving research support from the Swiss National Science Foundation (P300PB-167803/1) and speaker honoraria/consulting honoraria from Roche Diagnostics, Abbott Diagnostics, Siemens and Brahms. Dr. Mueller reports receiving research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel; Abbott, Alere, Astra Zeneca, Beckman Coulter, Biomerieux, Brahms, Roche, Siemens, Singulex, Sphingotec, and the Department of Internal Medicine, University Hospital Basel, as well as speaker honoraria/consulting honoraria from Abbott, Alere, Astra Zeneca, Biomerieux, Boehringer Ingelheim, BMS, Brahms, Cardiorentis, Novartis, Roche, Siemens, and Singulex.

References and notes
(1) The abstract “Validation of the European Society of Cardiology 0/1-hour algorithm for rule-out and rule-in of acute myocardial infarction” will be presented during:
·    The press conference - Cardiac interventions - expanding applications on Saturday 26 August from 15:00 to 16:00.
·   The session Chest pain in the emergency department: the “Biomarkers-Versus-Imaging-Dilemma” on Sunday 27 August from 16:30 to 18:00 in Bucharest – Village 8.
(2) 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. European Heart Journal. 2016;37:267–315. doi: 10.1093/eurheartj/ehv320
(3) Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) is an international multicentre study coordinated by the University Hospital of Basel, Switzerland. Biomarkers in Acute Cardiovascular Care (BACC) is a single centre study coordinated by the University Heart Centre Hamburg, Germany.

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This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2017. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.