Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design
Anna M Nordenskjöld, Stefan Agewall, Dan Atar, Tomasz Baron, John Beltrame, Olle Bergström, David Erlinge, Chris P Gale, Javier López-Pais, Tomas Jernberg, Pelle Johansson, Annica Ravn-Fisher, Harmony R Reynolds, Jithendra B Somaratne, Per Tornvall, Bertil Lindahl, Anna M Nordenskjöld, Stefan Agewall, Dan Atar, Tomasz Baron, John Beltrame, Olle Bergström, David Erlinge, Chris P Gale, Javier López-Pais, Tomas Jernberg, Pelle Johansson, Annica Ravn-Fisher, Harmony R Reynolds, Jithendra B Somaratne, Per Tornvall, Bertil Lindahl
Abstract
Myocardial infarction with non-obstructive coronary arteries (MINOCA) is common and occurs in 6-8% of all patients fulfilling the diagnostic criteria for acute myocardial infarction (AMI). This paper describes the rationale behind the trial 'Randomized Evaluation of Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment (ACEI/ARB) of MINOCA patients' (MINOCA-BAT) and the need to improve the secondary preventive treatment of MINOCA patients. METHODS: MINOCA-BAT is a registry-based, randomized, parallel, open-label, multicenter trial with 2:2 factorial design. The primary aim is to determine whether oral beta blockade compared with no oral beta blockade, and ACEI/ARB compared with no ACEI/ARB, reduce the composite endpoint of death of any cause, readmission because of AMI, ischemic stroke or heart failure in patients discharged after MINOCA without clinical signs of heart failure and with left ventricular ejection fraction ≥40%. A total of 3500 patients will be randomized into four groups; e.g. ACEI/ARB and beta blocker, beta blocker only, ACEI/ARB only and neither ACEI/ARB nor beta blocker, and followed for a mean of 4 years. SUMMARY: While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials. There is a limited basis for guideline recommendations in MINOCA. Furthermore, studies of routine clinical practice suggest that use of secondary prevention therapies in MINOCA varies considerably. Thus results from this trial may influence future treatment strategies and guidelines specific to MINOCA patients.
Trial registration: ClinicalTrials.gov NCT03686696.
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed