Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial.
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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, SMART-DECISION investigators
Аннотация
METHODS AND ANALYSIS: The 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 DISSEMINATION: Ethics 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 NUMBER: ClinicalTrials.gov, NCT04769362.