Discontinuation of β-blocker Therapy in Stabilised Patients After Acute Myocardial Infarction (SMART-DECISION): Rationale and Design of the Randomised Controlled Trial

Overview

Journal BMJ Open

Specialty General Medicine

Date 2024 Dec 7

PMID 39645270

Authors

Ki Hong Choi

Juwon Kim

Danbee Kang

Joon-Hyung Doh

Juhan Kim

Yong Hwan Park

Sung Gyun Ahn

Weon Kim

Jong Pil Park

Sang Min Kim

Byung-Ryul Cho

Chang-Wook Nam

Jang Hyun Cho

Seung-Jae Joo

Jon Suh

Jin-Ok Jeong

Woo Jang

Chang-Hwan Yoon

Jin-Yong Hwang

Seong-Hoon Lim

Sang-Rok Lee

Eun-Seok Shin

Byung Jin Kim

Cheol Woong Yu

Sung-Ho Her

Hyun Kuk Kim

Kyu Tae Park

Jihoon Kim

Taek Kyu Park

Joo-Myung Lee

Juhee Cho

Jeong Hoon Yang

Young Bin Song

Seung Hyuk Choi

Hyeon-Cheol Gwon

Eliseo Guallar

Joo-Yong Hahn

Affiliations

Soon will be listed here.

Abstract

Introduction: 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.

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.

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