Extending the no objective testing rules to patients triaged by the European Society of Cardiology 0/1-hour algorithms.

After rule-out of non-ST elevation myocardial infarction (NSTEMI) with the European Society of Cardiology (ESC) 0/1 h-algorithms, it is unclear which patients require further anatomical or functional cardiac testing. To test the safety and efficacy of the no-objective-testing (NOT)-rules after NSTEMI rule-out by the ESC 0/1 h-algorithms. International, prospective, diagnostic multicentre study enrolling adult patients presenting with chest pain to the emergency department. Central adjudication of final diagnosis by two independent cardiologists using information including cardiac imaging. Primary endpoints were the safety and efficacy of the NOT-rules for the rule-out of major adverse cardiovascular events (MACE). Secondary endpoints included 365-day and 2-year MACE. Among 4804 and 4569 patients with available 0/1 h high-sensitivity cardiac troponin (hs-cTn)T-Elecsys or hs-cTnI-Architect concentrations, 2783 (58%) and 2252 (49%) were eligible for application of the NOT-rules after rule-out of NSTEMI by the ESC hs-cTnT/I-0/1h-algorithm. The first rule identified 26% of patients with a sensitivity of 100% (95%CI 98.3-100%) and a negative predictive value (NPV) of 100% (95% CI, n.c.). The second and third rules both identified 31% of patients with a sensitivity of 99.5% (95% CI 97.4-99.9%) and a NPV of 99.9% (95% CI 99.2-99.9%). Similar findings emerged for hs-cTnI. High safety was confirmed for rule-out of 365-day and 2-year MACE and proven to be superior to the HEART Score. All three NOT-rules performed very well for rule-out of MACE. The third NOT-rule best balanced feasibility, safety, and efficacy by identifying nearly one out of three patients as low-risk and may not require further cardiac testing. https://clinicaltrials.gov/ct2/show/NCT00470587.

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Déclaration de conflit d'intérêts

Conflicts of interest: The authors designed the study, gathered and analyzed the data, vouched for the data and analysis, wrote the paper, and decided to publish. P.D.R., J.B., T.N., L.K., K.W., R.T., M.R.G., and C.M. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors have read and approved the manuscript. The sponsors had no role in designing or conducting the study and no role in gathering or analyzing the data or writing the manuscript. The manuscript and its contents have not been published previously and are not being considered for publication elsewhere in whole or in part in any language, including publicly accessible web sites or e-print servers. We disclose that J.B. has received research grants from the University of Basel, the University Hospital of Basel and the Division of Internal Medicine, the Swiss Academy of Medical Sciences, the Gottfried and Julia Bangerter Rhyner Foundation, and the Swiss National Science Foundation (P500PM_206636/1); and has received speaker honoraria and/or consulting honoraria from Siemens, Roche Diagnostics, Ortho Clinical Diagnostics, and Quidel Corporation, outside the submitted work. T.N. has received research support from the Swiss National Science Foundation (P400PM_191037/1), the Prof. Dr. Max Cloëtta Foundation, the Margarete und Walter Lichtenstein-Stiftung (3MS1038), and the University Hospital Basel as well as speaker honoraria/consulting honoraria from Siemens, Beckman Coulter, Bayer, Ortho Clinical Diagnostics and Orion Pharma, outside the submitted work. L.K. received a research grant from the University of Basel, the Swiss Academy of Medical Sciences and the Gottfried and Julia Bangerter Rhyner Foundation, as well as the “Freiwillige Akademische Gesellschaft Basel”. K.W. has received research support from the Gottfried and Julia Bangerter Rhyner Stiftung, The Prince Charles Hospital Foundation, the CRE Actions Fund (NHMRC), the University of Queensland, and the Wesley Medical Research Foundation, all outside of the submitted work. O.M. received grants from the Instituto de Salud Carlos III supported with funds from the Spanish Ministry of Health and FEDER (PI10/01918, PI11/01021, PI15/01019, PI15/00773), La Marató de TV3 (2015/2510) and from the Catalonian Government for Consolidated Groups of Investigation (GRC 2009/1385, 2014/0313, 2017/1424). M.R.G. reports research grants from Swiss National Science Foundation (P400PM_180828) and from the Swiss Heart Foundation and speakers/advisors’ honoraria from Roche, Ortho Clinical Diagnostics, Abbott and Siemens. R.T. reports research support from the Swiss National Science Foundation (Grant No P300PB_167803), the Swiss Heart Foundation, the Swiss Society of Cardiology, the Cardiovascular Research Foundation Basel, the University of Basel and the University Hospital Basel and speaker honoraria/consulting honoraria from Abbott, Amgen, Astra Zeneca, Roche, Siemens, Singulex and Thermo Scientific BRAHMS. C.M. has received research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the University of Basel, the University Hospital Basel, Abbott, Beckman Coulter, Biomerieux, Idorsia, Ortho Cinical Diagnostics, Quidel, Roche, Siemens, Singulex, Sphingotec, as well as speaker honoraria/consulting honoraria from Acon, Amgen, Astra Zeneca, Boehringer Ingelheim, Bayer, BMS, Idorsia, Novartis, Osler, Roche, Sanofi, outside of the submitted work. All other authors declare that they have no conflict of interest with this study.