PMID- 36476401 OWN - NLM STAT- MEDLINE DCOM- 20221215 LR - 20230517 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 23 IP - 1 DP - 2022 Dec 7 TI - An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study. PG - 986 LID - 10.1186/s13063-022-06907-4 [doi] LID - 986 AB - BACKGROUND: More than half of the world's population lives in Asia. With current life expectancies in Asian countries, the burden of cardiovascular disease is increasing exponentially. Overcrowding in the emergency departments (ED) has become a public health problem. Since 2015, the European Society of Cardiology recommends the use of a 0/1-h algorithm based on high-sensitivity cardiac troponin (hs-cTn) for rapid triage of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). However, these algorithms are currently not recommended by Asian guidelines due to the lack of suitable data. METHODS: The DROP-Asian ACS is a prospective, stepped wedge, cluster-randomized trial enrolling 4260 participants presenting with chest pain to the ED of 12 acute care hospitals in five Asian countries (UMIN; 000042461). Consecutive patients presenting with suspected acute coronary syndrome between July 2022 and Apr 2024 were included. Initially, all clusters will apply "usual care" according to local standard operating procedures including hs-cTnT but not the 0/1-h algorithm. The primary outcome is the incidence of major adverse cardiac events (MACE), the composite of all-cause death, myocardial infarction, unstable angina, or unplanned revascularization within 30 days. The difference in MACE (with one-sided 95% CI) was estimated to evaluate non-inferiority. The non-inferiority margin was prespecified at 1.5%. Secondary efficacy outcomes include costs for healthcare resources and duration of stay in ED. CONCLUSIONS: This study provides important evidence concerning the safety and efficacy of the 0/1-h algorithm in Asian countries and may help to reduce congestion of the ED as well as medical costs. CI - (c) 2022. The Author(s). FAU - Inoue, Kenji AU - Inoue K AUID- ORCID: 0000-0002-7193-8421 AD - Department of Cardiovascular Biology and Medicine, Juntendo University Nerima Hospital, Tokyo, Japan. inouelsbm@gmail.com. FAU - Chieh, Jack Tan Wei AU - Chieh JTW AD - Department of Cardiology, National Heart Centre Singapore and Sengkang General Hospital, Singapore, Singapore. FAU - Yeh, Lim Chiw AU - Yeh LC AD - Department of Cardiology, National Heart Centre Singapore and Sengkang General Hospital, Singapore, Singapore. FAU - Chiang, Shuo-Ju AU - Chiang SJ AD - Division of Cardiology, Department of Internal Medicine, Taipei City Hospital Yangming Branch, Taipei, Taiwan. FAU - Phrommintikul, Arintaya AU - Phrommintikul A AD - Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiangmai, Thailand. FAU - Suwanasom, Pannipa AU - Suwanasom P AD - Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiangmai, Thailand. FAU - Kasim, Sazzli AU - Kasim S AD - Division of Cardiology, Hospital Al-Sultan Abdullah, University Teknologi MARA, Kuala Lumpur, Malaysia. FAU - Ahmad, Bakhtiar AU - Ahmad B AD - Division of Cardiology, Hospital Al-Sultan Abdullah, University Teknologi MARA, Kuala Lumpur, Malaysia. FAU - Idrose, Alzamani Mohammad AU - Idrose AM AD - Division of Emergency, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia. FAU - Salleh, Farina Mohd AU - Salleh FM AD - Division of Emergency, Institut Jantung Negara, Kuala Lumpur, Malaysia. FAU - Oyamada, Shunsuke AU - Oyamada S AD - Departments of Biostatistics, JORTC Data Center, Tokyo, Japan. FAU - Hirano, Yohei AU - Hirano Y AD - Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Chiba, Japan. FAU - Ouchi, Shohei AU - Ouchi S AD - Department of Cardiovascular Biology and Medicine, Juntendo Urayasu Hospital, Chiba, Japan. FAU - Terakura, Moriyuki AU - Terakura M AD - Department of Emergency, Teikyo University School of Medicine, Tokyo, Japan. FAU - Yokoyama, Naoyuki AU - Yokoyama N AD - Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan. FAU - Kozuma, Ken AU - Kozuma K AD - Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan. FAU - Nanasato, Mamoru AU - Nanasato M AD - Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan. FAU - Higuchi, Ryosuke AU - Higuchi R AD - Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan. FAU - Yumoto, Kazuhiko AU - Yumoto K AD - Department of Cardiology, Yokohama Rosai Hospital, Kanagawa, Japan. FAU - Fukuzawa, Tomoyuki AU - Fukuzawa T AD - Department of Cardiology, Yokohama Rosai Hospital, Kanagawa, Japan. FAU - Shimada, Issei AU - Shimada I AD - Shimada General Hospital, Chiba, Japan. FAU - Giannitsis, Evangelos AU - Giannitsis E AD - Department of Cardiology, University Hospital Heidelberg, Heidelberg, Germany. FAU - Twerenbold, Raphael AU - Twerenbold R AD - Department of Cardiology and University Center of Cardiovascular Science, University Heart and Vascular Center Hamburg, Hamburg, Germany. FAU - Minamino, Tohru AU - Minamino T AD - Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan. LA - eng GR - 18K09954/Grant-in-Aid for Scientific Research/ PT - Journal Article PT - Randomized Controlled Trial DEP - 20221207 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM EIN - Trials. 2023 May 17;24(1):335. PMID: 37198646 MH - Humans MH - *Acute Coronary Syndrome/diagnosis/therapy MH - Prospective Studies MH - Asia/epidemiology PMC - PMC9727900 OTO - NOTNLM OT - 0-h/1-h algorithm OT - High-sensitivity troponin T OT - Non-ST elevation of acute coronary syndrome OT - Overcrowding emergency department COIS- Dr. Inoue has received research grant from Grant-in-Aid for Scientific Research C, No. 18K09954), Roche Diagnostics, SB Bioscience Co., Ltd., Fujirebio Inc., Bayel Sysmex and Kanto Chemical Co. Inc. Dr. Twerenbold 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. Dr. Giannitsis declares honoraria for lectures from Daiichi Sankyo, Astra Zeneca, Roche Diagnostics, Boehringer Ingelheim, Bayer Vital, and BRAHMS GmbH. He receives research funding from Daiichi Sankyo and Roche Diagnostics. He consults Roche Diagnostics, Astra Zeneca, Bayer Vital, Indorsia, Radiometer, BRAHMS GmbH, Hoffmann-La Roche, and Boehringer Ingelheim. Dr. JWCT has received honoraria from AstraZeneca, Bayer, Amgen, Medtronic, Abbott Vascular, Biosensors, Alvimedica, Boehringer Ingelheim, and Pfizer; research and educational grants from Medtronic, Biosensors, Biotronik, Philips, Amgen, AZ, Roche, Ostuka, Terumo, and Abbott Vascular; and consulting fees from Elixir, CSL Behring. Dr. Minamino has received research grant from Roche Diagnostics. EDAT- 2022/12/09 06:00 MHDA- 2022/12/15 06:00 PMCR- 2022/12/07 CRDT- 2022/12/08 10:21 PHST- 2022/03/26 00:00 [received] PHST- 2022/11/09 00:00 [accepted] PHST- 2022/12/08 10:21 [entrez] PHST- 2022/12/09 06:00 [pubmed] PHST- 2022/12/15 06:00 [medline] PHST- 2022/12/07 00:00 [pmc-release] AID - 10.1186/s13063-022-06907-4 [pii] AID - 6907 [pii] AID - 10.1186/s13063-022-06907-4 [doi] PST - epublish SO - Trials. 2022 Dec 7;23(1):986. doi: 10.1186/s13063-022-06907-4.