Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT)
Key result
Post-discharge β-blockers are hypothesized to reduce major events ~20% vs. no treatment.
- HR 0.80
- 95% CI null
- P null
- n=8,468
Why the study?
Evidence is lacking regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction without reduced LVEF.
Does beta-blocker therapy reduce the composite of all-cause death, nonfatal reinfarction, or HF hospitalization in patients discharged after acute myocardial infarction with LVEF >40%?
Population
Patients discharged after invasively managed MI, with LVEF >40% and no history of HF
Comparison
β-blocker therapy vs no β-blocker therapy
Design
Pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE) trial
Follow-up
Median 2.75 years (minimum 2 years, maximum 3 years)
Authors
Discussion
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Implication
Tests β-blocker benefit post-MI with LVEF >40%; extends prior evidence to preserved-EF patients.
Study Design
Type
RCT (n=8,468)
Blinding
Open-label blinded endpoint (PROBE design)
Randomization
1:1 randomization to β-blocker therapy or no β-blocker therapy
Multicenter
Yes
Structured PICO
Does beta-blocker therapy reduce the composite of all-cause death, nonfatal reinfarction, or HF hospitalization in patients discharged after acute myocardial infarction with LVEF >40%?
P
Population
8,468 (planned) acute myocardial infarction (MI) survivors (STEMI or NSTEMI) managed invasively during index hospitalization, with LVEF >40%, and no history of heart failure (HF) or Killip class ≥II.
I
Intervention
β-blocker therapy (agent and dose chosen by treating physician)
C
Comparator
No β-blocker therapy (both groups treated according to current standards as judged by attending physician)
O
Outcome
Composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 yearscomposite
Main Result
Effect estimate: HR 0.80 (95% CI null)
p-value: p=null
The REBOOT trial is designed to determine whether routine beta-blocker therapy improves clinical outcomes in patients with acute myocardial infarction and preserved ejection fraction.
Limitations
- Potential overestimation of β-blocker effects due to lack of a placebo
- High potential for crossover between treatment groups
- Non-homogeneity of drug and dose in the treatment arm
- Lack of a placebo introduces a theoretical risk of overestimation of the effect on patient-reported outcomes
- Possible bias toward the null hypothesis because of a potentially high proportion of crossovers
- Possible difficulties in interpretation due to the non-homogeneity of drug and dose in the treatment arm
- Assumes a drug class effect
- Includes both type 1 and type 2 MI despite differences in pathophysiology and prognosis
- Heart rate during follow-up is not recorded
Cite This Study
Rosselló et al. (2021) conducted an RCT in Acute myocardial infarction without reduced ejection fraction (n=8,468). β-blockers vs. No β-blocker therapy was evaluated on Composite of all-cause death, nonfatal reinfarction, or HF hospitalization (HR 0.80, 95% CI null, p=null). Post-discharge β-blocker treatment is hypothesized to reduce the composite event rate of all-cause death, nonfatal reinfarction, and HF hospitalization by 20% compared to no treatment over a median follow-up of 2.75 years.