Beta Blocker De-prescription Following Coronary Artery Bypass Graft Surgery (BEEFBURGER Trial).

University of Saskatchewan

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Coronary Artery Stenosis; Acute Myocardial Infarction; Non-ST Elevation Myocardial Infarction (NSTEMI)

Treatments: Drug: De-prescribe beta blocker therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04788186

UofS REB Bio#2639

Details and patient eligibility

About

Beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. In patients without these high-risk features treated with coronary artery bypass graft (CABG) surgery, their continued long-term role is unclear.

Full description

This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon.

Patients treated with isolated CABG (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (EF ≥45%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. After obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care OR beta-blocker de-prescription as per the study protocol.

The primary objective of this study is to demonstrate recruitment feasibility for beta-blocker de-prescription 6-8 weeks following uncomplicated CABG. Exploratory outcomes include the composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, and cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia [supraventricular including atrial fibrillation, and ventricular], syncope or need for pacemaker) over a 3-year follow up duration.

Other exploratory outcomes will include a change in the patient reported quality of life using the Short Form (SF) 36 and Euro Qol (EQ) 5D questionnaires and angina score using the Seattle Angina Questionnaire (SAQ).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years treated with index isolated CABG
• Able to consent to study
• On beta blocker therapy at the 6-8week visit
• LV systolic function (≥45% assessed within 6months of CABG date)

Exclusion criteria

• Prior heart failure with reduced ejection fraction (LVEF <45%)
• Pre- or peri-operative atrial fibrillation or flutter
• Peri-CABG stroke
• Unable to follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Continue beta blocker therapy

No Intervention group

Description:

Participants in this arm will continue their beta blocker therapy as per their usual clinical care

De-prescribe beta blocker therapy

Experimental group

Description:

Beta blocker therapy will be de-prescribed in this arm

Treatment:

Drug: De-prescribe beta blocker therapy