BEtablocker Treatment After acute Myocardial Infarction in revascularized patients without reduced left ventricular ejection fraction (BETAMI): Rationale and design of a prospective, randomized, open, blinded end point study - 20/02/19
, Vidar Ruddox, MD, PhD c, Sigrun Halvorsen, MD, PhD d, Toril Dammen, MD, PhD b, Morten W Fagerland, PhD e, Kjersti H Hernæs, Cand. Econ f, Nils Tore Vethe, PhD g, Eva Prescott, MD, DMSc h, Svend Eggert Jensen, MD, PhD i, Olaf Rødevand, MD, PhD j, Jarle Jortveit, MD, PhD k, Bjørn Bendz, MD, PhD l, Henrik Schirmer, MD, PhD m, Lars Køber, MD, PhD n, Hans Erik Bøtker, MD, PhD o, Alf Inge Larsen, MD, PhD p, Kjell Vikenes, MD, PhD q, Terje Steigen, MD, PhD r, Rune Wiseth, MD, PhD s, Terje Pedersen, MD, PhD t, Thor Edvardsen, MD, PhD l, Jan Erik Otterstad, MD, PhD b, Dan Atar, MD, PhD dAbstract |
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.
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| Declaration of conflicting interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. |
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| RCT# 2018-000590-75. |
Vol 208
P. 37-46 - février 2019 Retour au numéro
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