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

John Munkhaugen; Vidar Ruddox; Sigrun Halvorsen; Toril Dammen; Morten W Fagerland; Kjersti H Hernæs; Nils Tore Vethe; Eva Prescott; Svend Eggert Jensen; Olaf Rødevand; Jarle Jortveit; Bjørn Bendz; Henrik Schirmer; Lars Køber; Hans Erik Bøtker; Alf Inge Larsen; Kjell Vikenes; Terje Steigen; Rune Wiseth; Terje Pedersen; Thor Edvardsen; Jan Erik Otterstad; Dan Atar

doi:10.1016/j.ahj.2018.10.005

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

John Munkhaugen, Vidar Ruddox, Sigrun Halvorsen, Toril Dammen, Morten W Fagerland, Kjersti H Hernæs, Nils Tore Vethe, Eva Prescott, Svend Eggert Jensen, Olaf Rødevand, Jarle Jortveit, Bjørn Bendz, Henrik Schirmer, Lars Køber, Hans Erik Bøtker, Alf Inge Larsen, Kjell Vikenes, Terje Steigen, Rune Wiseth, Terje PedersenThor Edvardsen, Jan Erik Otterstad, Dan Atar

53 Citations (Scopus)

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.

Original language	English
Journal	American Heart Journal
Volume	208
Pages (from-to)	37-46
Number of pages	10
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2018.10.005
Publication status	Published - 1 Feb 2019

Keywords

Administration, Oral
Adrenergic beta-Antagonists/administration & dosage
Adult
Cause of Death
Humans
Myocardial Infarction/complications
Norway
Percutaneous Coronary Intervention
Prospective Studies
Recurrence
Research Design
Secondary Prevention/methods
Stroke Volume
Thrombolytic Therapy
Ventricular Dysfunction, Left/complications

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Munkhaugen, J., Ruddox, V., Halvorsen, S., Dammen, T., Fagerland, M. W., Hernæs, K. H., Vethe, N. T., Prescott, E., Jensen, S. E., Rødevand, O., Jortveit, J., Bendz, B., Schirmer, H., Køber, L., Bøtker, H. E., Larsen, A. I., Vikenes, K., Steigen, T., Wiseth, R., ... Atar, D. (2019). 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. American Heart Journal, 208, 37-46. https://doi.org/10.1016/j.ahj.2018.10.005

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. / Munkhaugen, John; Ruddox, Vidar; Halvorsen, Sigrun et al.
In: American Heart Journal, Vol. 208, 01.02.2019, p. 37-46.

Research output: Contribution to journal › Journal article › Research › peer-review

Munkhaugen, J, Ruddox, V, Halvorsen, S, Dammen, T, Fagerland, MW, Hernæs, KH, Vethe, NT, Prescott, E, Jensen, SE, Rødevand, O, Jortveit, J, Bendz, B, Schirmer, H, Køber, L, Bøtker, HE, Larsen, AI, Vikenes, K, Steigen, T, Wiseth, R, Pedersen, T, Edvardsen, T, Otterstad, JE & Atar, D 2019, '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', American Heart Journal, vol. 208, pp. 37-46. https://doi.org/10.1016/j.ahj.2018.10.005

Munkhaugen J, Ruddox V, Halvorsen S, Dammen T, Fagerland MW, Hernæs KH et al. 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. American Heart Journal. 2019 Feb 1;208:37-46. doi: 10.1016/j.ahj.2018.10.005

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title = "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",

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.",

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author = "John Munkhaugen and Vidar Ruddox and Sigrun Halvorsen and Toril Dammen and Fagerland, \{Morten W\} and Hern{\ae}s, \{Kjersti H\} and Vethe, \{Nils Tore\} and Eva Prescott and Jensen, \{Svend Eggert\} and Olaf R{\o}devand and Jarle Jortveit and Bj{\o}rn Bendz and Henrik Schirmer and Lars K{\o}ber and B{\o}tker, \{Hans Erik\} and Larsen, \{Alf Inge\} and Kjell Vikenes and Terje Steigen and Rune Wiseth and Terje Pedersen and Thor Edvardsen and Otterstad, \{Jan Erik\} and Dan Atar",

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doi = "10.1016/j.ahj.2018.10.005",

language = "English",

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journal = "American Heart Journal",

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T1 - BEtablocker Treatment After acute Myocardial Infarction in revascularized patients without reduced left ventricular ejection fraction (BETAMI)

T2 - Rationale and design of a prospective, randomized, open, blinded end point study

AU - Munkhaugen, John

AU - Ruddox, Vidar

AU - Halvorsen, Sigrun

AU - Dammen, Toril

AU - Fagerland, Morten W

AU - Hernæs, Kjersti H

AU - Vethe, Nils Tore

AU - Prescott, Eva

AU - Jensen, Svend Eggert

AU - Rødevand, Olaf

AU - Jortveit, Jarle

AU - Bendz, Bjørn

AU - Schirmer, Henrik

AU - Køber, Lars

AU - Bøtker, Hans Erik

AU - Larsen, Alf Inge

AU - Vikenes, Kjell

AU - Steigen, Terje

AU - Wiseth, Rune

AU - Pedersen, Terje

AU - Edvardsen, Thor

AU - Otterstad, Jan Erik

AU - Atar, Dan

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Adrenergic beta-Antagonists/administration & dosage

KW - Adult

KW - Cause of Death

KW - Humans

KW - Myocardial Infarction/complications

KW - Norway

KW - Percutaneous Coronary Intervention

KW - Prospective Studies

KW - Recurrence

KW - Research Design

KW - Secondary Prevention/methods

KW - Stroke Volume

KW - Thrombolytic Therapy

KW - Ventricular Dysfunction, Left/complications

UR - https://www.scopus.com/pages/publications/85057808059

U2 - 10.1016/j.ahj.2018.10.005

DO - 10.1016/j.ahj.2018.10.005

M3 - Journal article

C2 - 30530121

SN - 0002-8703

VL - 208

SP - 37

EP - 46

JO - American Heart Journal

JF - American Heart Journal

ER -

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

Abstract

Keywords

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