John Munkhaugen1, Vidar Ruddox2, Sigrun Halvorsen3, Toril Dammen4, Morten W Fagerland5, Kjersti H Hernæs6, Nils Tore Vethe7, Eva Prescott8, Svend Eggert Jensen9, Olaf Rødevand10, Jarle Jortveit11, Bjørn Bendz12, Henrik Schirmer13, Lars Køber14, Hans Erik Bøtker15, Alf Inge Larsen16, Kjell Vikenes17, Terje Steigen18, Rune Wiseth19, Terje Pedersen20, Thor Edvardsen12, Jan Erik Otterstad4, Dan Atar3. 1. Department of Medicine, Drammen Hospital, Vestre Viken Trust, Drammen, Norway; Department of Behavioural Science in Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: johmun@vestreviken.no. 2. Department for Cardiology, Vestfold Hospital Trust, Tønsberg, Norway. 3. Department of Cardiology, Oslo University Hospital, Ullevaal and Faculty of Medicine, University of Oslo, Oslo, Norway. 4. Department of Behavioural Science in Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. 5. Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway. 6. Clinical Trial Unit Health economics, Oslo University Hospital, Oslo, Norway. 7. Department of Pharmacology, Oslo University Hospital, Oslo, Norway. 8. Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. 9. Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. 10. LHL Department of Cardiology, LHL Hospital Gardermoen, Gardermoen, Norway. 11. Department of Cardiology, Sørlandet Hospital Arendal, Arendal, Norway. 12. Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway. 13. Department of Cardiology, Akershus University Hospital AHUS, Lørenskog, Norway. 14. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. 15. Department of Cardiology, Aarhus University Hospital Skejby, Skejby, Denmark. 16. Department of Cardiology, Stavanger University Hospital, Stavanger, Norway. 17. Department of Heart Disease, Haukeland University Hospital, Bergen, Norway. 18. Department of Cardiology, University Hospital of North Norway and the Arctic University of Norway, Tromsø, Norway. 19. Clinic of Cardiology, St Olavs University Hospital, Trondheim, Norway. 20. Oslo University Hospital, Ullevaal and Faculty of Medicine, University of Oslo, Oslo, Norway.
Abstract
BACKGROUND: Current guidelines on the use of β-blockers in post-acute myocardial infarction (MI) patients without reduced left ventricular ejection fraction (LVEF) are based on studies before the implementation of modern reperfusion and secondary prevention therapies. It remains unknown whether β-blockers will reduce mortality and recurrent MI in contemporary revascularized post-MI patients without reduced LVEF. DESIGN: BETAMI is a prospective, randomized, open, blinded end point multicenter study in 10,000 MI patients designed to test the superiority of oral β-blocker therapy compared to no β-blocker therapy. Patients with LVEF ≥40% following treatment with percutaneous coronary intervention or thrombolysis and/or no clinical signs of heart failure are eligible to participate. The primary end point is a composite of all-cause mortality or recurrent MI obtained from national registries over a mean follow-up period of 3 years. Safety end points include rates of nonfatal MI, all-cause mortality, ventricular arrhythmias, and hospitalizations for heart failure obtained from hospital medical records 30 days after randomization, and from national registries after 6 and 18 months. Key secondary end points include recurrent MI, heart failure, cardiovascular and all-cause mortality, and clinical outcomes linked to β-blocker therapy including drug adherence, adverse effects, cardiovascular risk factors, psychosocial factors, and health economy. Statistical analyses will be conducted according to the intention-to-treat principle. A prespecified per-protocol analysis (patients truly on β-blockers or not) will also be conducted. CONCLUSIONS: The results from the BETAMI trial may have the potential of changing current clinical practice for treatment with β-blockers following MI in patients without reduced LVEF. EudraCT number 2018-000590-75.
RCT Entities:
BACKGROUND: Current guidelines on the use of β-blockers in post-acute myocardial infarction (MI) patients without reduced left ventricular ejection fraction (LVEF) are based on studies before the implementation of modern reperfusion and secondary prevention therapies. It remains unknown whether β-blockers will reduce mortality and recurrent MI in contemporary revascularized post-MI patients without reduced LVEF. DESIGN:BETAMI is a prospective, randomized, open, blinded end point multicenter study in 10,000 MI patients designed to test the superiority of oral β-blocker therapy compared to no β-blocker therapy. Patients with LVEF ≥40% following treatment with percutaneous coronary intervention or thrombolysis and/or no clinical signs of heart failure are eligible to participate. The primary end point is a composite of all-cause mortality or recurrent MI obtained from national registries over a mean follow-up period of 3 years. Safety end points include rates of nonfatal MI, all-cause mortality, ventricular arrhythmias, and hospitalizations for heart failure obtained from hospital medical records 30 days after randomization, and from national registries after 6 and 18 months. Key secondary end points include recurrent MI, heart failure, cardiovascular and all-cause mortality, and clinical outcomes linked to β-blocker therapy including drug adherence, adverse effects, cardiovascular risk factors, psychosocial factors, and health economy. Statistical analyses will be conducted according to the intention-to-treat principle. A prespecified per-protocol analysis (patients truly on β-blockers or not) will also be conducted. CONCLUSIONS: The results from the BETAMI trial may have the potential of changing current clinical practice for treatment with β-blockers following MI in patients without reduced LVEF. EudraCT number 2018-000590-75.
Authors: Anna Meta Dyrvig Kristensen; Ann Bovin; Ann Dorthe Zwisler; Charlotte Cerquira; Christian Torp-Pedersen; Hans Erik Bøtker; Ida Gustafsson; Karsten Tange Veien; Kristian Korsgaard Thomsen; Michael Hecht Olsen; Mogens Lytken Larsen; Olav Wendelboe Nielsen; Per Hildebrandt; Sussie Foghmar; Svend Eggert Jensen; Theis Lange; Thomas Sehested; Tomas Jernberg; Dan Atar; Borja Ibanez; Eva Prescott Journal: Trials Date: 2020-05-23 Impact factor: 2.279