Anna M Nordenskjöld1, Stefan Agewall2, Dan Atar2, Tomasz Baron3, John Beltrame4, Olle Bergström5, David Erlinge6, Chris P Gale7, Javier López-Pais8, Tomas Jernberg9, Pelle Johansson10, Annica Ravn-Fisher11, Harmony R Reynolds12, Jithendra B Somaratne13, Per Tornvall14, Bertil Lindahl3. 1. Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. Electronic address: anna.nordenskjold@regionorebrolan.se. 2. Department of Cardiology, Oslo University Hospital, Norway, and Institute of Clinical Sciences, University of Oslo, Norway. 3. Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 4. Discipline of Medicine, University of Adelaide, Basil Hetzel Institute, Central Adelaide Local Health Network, Adelaide, Australia. 5. Department of Medicine/Cardiology, County Hospital of Kronoberg, Sweden. 6. Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden. 7. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK. 8. Department of Cardiology, University Hospital Complex of Santiago de Compostela, Spain. 9. Department of clinical sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. 10. Senior research manager, The Swedish Heart and Lung Association, Sweden. 11. Department of Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden. 12. Sarah Ross Soter Center for Women's Cardiovascular Research, Leon H. Charney Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York. 13. Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand. 14. Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
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.
RCT Entities:
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.
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