TY - JOUR

T1 - The Danish-Norwegian randomized trial on beta-blocker therapy after myocardial infarction

T2 - Design, rationale, and baseline characteristics

AU - Kristensen, Anna Meta Dyrvig

AU - Munkhaugen, John

AU - Halvorsen, Sigrun

AU - Olsen, Michael Hecht

AU - Bakken, Arnhild

AU - Sehested, Thomas Steen Gyldenstierne

AU - Ruddox, Vidar

AU - Lange, Theis

AU - Fagerland, Morten Wang

AU - Torp-Pedersen, Christian

AU - Prescott, Eva

AU - Atar, Dan

N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2024

Y1 - 2024

N2 - AIM: The evidence for beta-blocker therapy after myocardial infarction (MI) is randomized trials conducted more than 30 years ago, and the continued efficacy has been questioned.DESIGN AND METHODS: The ongoing Danish (DANBLOCK) and Norwegian (BETAMI) randomized beta-blocker trials are joined to evaluate the effectiveness and risks of long-term beta-blocker therapy after MI. Patients with normal or mildly reduced left ventricular ejection fraction (LVEF≥40%) will be randomized to open-label treatment with beta-blockers or no such therapy. This event-driven trial will randomize ∼5700 patients and continue until 950 primary endpoints have occurred. As of July 2023, 5228 patients have been randomized. Of the first 4000 patients randomized, median age was 62 years, 79% were men, 48% had a STEMI, and 84% had a normal LVEF. The primary endpoint is a composite of adjudicated recurrent MI, incident heart failure, coronary revascularization, ischemic stroke, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest. The primary safety endpoint includes a composite of recurrent MI, heart failure, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest 30 days after randomization. Secondary endpoints include each of the components of the primary endpoint, patient-reported outcomes, and other clinical outcomes linked to beta-blocker therapy. The primary analysis will be conducted according to the intention-to-treat principle using a Cox proportional hazards regression model. End of follow-up is expected in December 2024.CONCLUSION: The combined BETAMI-DANBLOCK trial will have the potential to affect current clinical practice for beta-blocker therapy in patients with normal or mildly reduced LVEF after MI.

AB - AIM: The evidence for beta-blocker therapy after myocardial infarction (MI) is randomized trials conducted more than 30 years ago, and the continued efficacy has been questioned.DESIGN AND METHODS: The ongoing Danish (DANBLOCK) and Norwegian (BETAMI) randomized beta-blocker trials are joined to evaluate the effectiveness and risks of long-term beta-blocker therapy after MI. Patients with normal or mildly reduced left ventricular ejection fraction (LVEF≥40%) will be randomized to open-label treatment with beta-blockers or no such therapy. This event-driven trial will randomize ∼5700 patients and continue until 950 primary endpoints have occurred. As of July 2023, 5228 patients have been randomized. Of the first 4000 patients randomized, median age was 62 years, 79% were men, 48% had a STEMI, and 84% had a normal LVEF. The primary endpoint is a composite of adjudicated recurrent MI, incident heart failure, coronary revascularization, ischemic stroke, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest. The primary safety endpoint includes a composite of recurrent MI, heart failure, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest 30 days after randomization. Secondary endpoints include each of the components of the primary endpoint, patient-reported outcomes, and other clinical outcomes linked to beta-blocker therapy. The primary analysis will be conducted according to the intention-to-treat principle using a Cox proportional hazards regression model. End of follow-up is expected in December 2024.CONCLUSION: The combined BETAMI-DANBLOCK trial will have the potential to affect current clinical practice for beta-blocker therapy in patients with normal or mildly reduced LVEF after MI.

U2 - 10.1093/ehjcvp/pvad093

DO - 10.1093/ehjcvp/pvad093

M3 - Journal article

C2 - 38017624

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

SN - 2055-6837

ER -