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
Department of Cardiology, Samsung Medical Center, Seoul, Republic of Korea.
Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea.
BMJ Open. 2024 Aug 31;14(8):e086971. doi: 10.1136/bmjopen-2024-086971.
There 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.
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 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.
ClinicalTrials.gov, NCT04769362.
缺乏证据支持在无心力衰竭（HF）或左心室收缩功能障碍的急性心肌梗死（AMI）患者病情稳定后延长β受体阻滞剂治疗的有效性。
SMart血管成形术研究团队：冠状动脉疾病或结构性心脏病介入治疗患者的药物治疗决策（SMART-DECISION）试验是一项多中心、前瞻性、开放标签、随机、非劣效性试验，旨在确定AMI后病情稳定的患者在维持治疗≥1年后停用β受体阻滞剂治疗是否不劣于继续使用。符合参与条件的患者是那些无HF或左心室收缩功能障碍（射血分数>40%）且在AMI后已持续使用β受体阻滞剂治疗≥1年的患者。总共2540名患者将按1:1随机分组，分别继续或停用β受体阻滞剂治疗。随机分组将根据AMI类型（即ST段抬高型心肌梗死或非ST段抬高型心肌梗死）、β受体阻滞剂类型（卡维地洛、比索洛尔、奈必洛尔或其他）和参与中心进行分层。主要研究终点是在中位随访期3.5年（最短2.5年；最长4.5年）内全因死亡、心肌梗死和因HF住院的复合终点。与β受体阻滞剂治疗相关的不良反应、房颤的发生、医疗费用以及患者报告结局测量信息系统-29问卷的回答也将作为次要终点收集。
本研究已获得三星医疗中心机构审查委员会的伦理批准（编号2020-10-176）。在随机分组前，每位参与者均获得知情同意。本研究结果将提交至国际同行评审期刊发表，关键研究结果将在国际科学会议上展示。
ClinicalTrials.gov，NCT04769362。
