Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial

• Published in: BMJ open Vol. 14; no. 8; p. e086971
• Main Authors: Choi, Ki Hong, Kim, Juwon, Kang, Danbee, Doh, Joon-Hyung, Kim, Juhan, Park, Yong Hwan, Ahn, Sung Gyun, Kim, Weon, Park, Jong Pil, Kim, Sang Min, Cho, Byung-Ryul, Nam, Chang-Wook, Cho, Jang Hyun, Joo, Seung-Jae, Suh, Jon, Jeong, Jin-Ok, Jang, Woo, Yoon, Chang-Hwan, Hwang, Jin-Yong, Lim, Seong-Hoon, Lee, Sang-Rok, Shin, Eun-Seok, Kim, Byung Jin, Yu, Cheol Woong, Her, Sung-Ho, Kim, Hyun Kuk, Park, Kyu Tae, Kim, Jihoon, Park, Taek Kyu, Lee, Joo-Myung, Cho, Juhee, Yang, Jeong Hoon, Song, Young Bin, Choi, Seung Hyuk, Gwon, Hyeon-Cheol, Guallar, Eliseo, Hahn, Joo-Yong
• Format: Journal Article
• Language: English
• Published: London British Medical Journal Publishing Group 31.08.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Cardiac arrhythmia; Cardiovascular disease; Cardiovascular Medicine; Clinical outcomes; clinical trial; Contraindications; Costs; Ejection fraction; Electrocardiography; Health care expenditures; Heart attacks; Heart failure; Hospitalization; Information systems; Informed consent; Ischemia; Kinases; myocardial infarction; patient reported outcome measures; Patients; Protocol; Quality of life; Questionnaires
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-086971

IntroductionThere is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction.Methods and analysisThe SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI. A total of 2540 patients will be randomised 1:1 to continuation of β-blocker therapy or not. Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol or other) and participating centre. The primary study endpoint is a composite of all-cause death, MI and hospitalisation for HF over a median follow-up period of 3.5 years (minimum, 2.5 years; maximum, 4.5 years). Adverse effects related to β-blocker therapy, the occurrence of atrial fibrillation, medical costs and Patient-reported Outcomes Measurement Information system-29 questionnaire responses will also be collected as secondary endpoints.Ethics and disseminationEthics approval for this study was granted by the Institutional Review Board of Samsung Medical Center (no. 2020-10-176). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.Trial registration numberClinicalTrials.gov, NCT04769362.