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Outcomes in the BETAMI-DANBLOCK trial compared with a Norwegian nationwide myocardial infarction population
Anna Meta Dyrvig Kristensen1, Jarle Jortveit2, Therese Holmager1
1Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, 2000 Frederiksberg, Copenhagen, Denmark.
Insights
Beta-blockers effectively reduce mortality risk in myocardial infarction (MI) patients without heart failure. This study confirms their consistent benefit, even when trial participants differ from a broader patient registry.
Area of Science:
- Cardiology
- Clinical Trials
- Public Health
Background:
- The BETAMI-DANBLOCK trial demonstrated beta-blocker efficacy in myocardial infarction (MI) patients with preserved ejection fraction.
- Representativeness of trial populations to real-world patients is crucial for treatment guideline applicability.
Purpose of the Study:
- To assess the representativeness of the BETAMI-DANBLOCK trial population compared to a broader cohort of MI patients.
- To evaluate the generalizability of beta-blocker treatment effects in MI patients with LVEF ≥ 40%.
Main Methods:
- Comparison of baseline characteristics between BETAMI-DANBLOCK participants and the Norwegian Myocardial Infarction Registry (NORMI) cohort.
- Estimation of absolute risks for all-cause mortality and MI at 3-year follow-up.
- Transportability analysis using population weighting to adjust for cohort differences.
Main Results:
- The NORMI cohort was older and had a higher prevalence of diabetes, prior coronary artery disease, and lower-normal ejection fraction (LVEF 40-49%) compared to trial participants.
- Absolute 3-year risks of all-cause mortality or MI were higher in the NORMI cohort (12.0%) than in BETAMI (7.7%) and DANBLOCK (7.8%).
- Beta-blocker treatment effects on mortality or MI remained consistent after weighting the trial population to match NORMI cohort characteristics.
Conclusions:
- BETAMI-DANBLOCK participants represented a healthier subgroup compared to the general MI population in the NORMI registry.
- Despite baseline differences, beta-blockers demonstrated consistent efficacy in reducing adverse cardiovascular events, supporting their use in MI patients with LVEF ≥ 40%.
Background And Aims:
In patients with myocardial infarction (MI), no heart failure, and left ventricular ejection fraction (LVEF) ≥ 40%, the combined BETAMI-DANBLOCK trial showed that beta-blockers reduced the risk of all-cause mortality or major adverse cardiovascular events. This study evaluated the representativeness of the trial.
Methods:
Participants in BETAMI (n = 2867) and DANBLOCK (n = 2707) were compared with a cohort of revascularized MI patients with LVEF ≥40%, and no heart failure from the Norwegian Myocardial Infarction Registry (the NORMI cohort)(n = 20 804). Baseline characteristics were evaluated, and absolute risks of all-cause mortality and/or MI were estimated. A transportability analysis was conducted by weighting the BETAMI-DANBLOCK population according to the NORMI cohort.
Results:
Median age was 66 years (interquartile range [IQR]: 57-74) in the NORMI cohort and 63 years (IQR: 55-70) in BETAMI and DANBLOCK. Patients in the NORMI cohort had a higher prevalence of diabetes, previous coronary artery disease, and LVEF 40-49%, compared with trial participants. At 3-year follow-up, the absolute risk of all-cause mortality or MI was 12.0% in the NORMI cohort, 7.7% in BETAMI, and 7.8% in DANBLOCK. Corresponding risks of MI were 6.3%, 5.6%, and 4.3%, respectively. The treatment effects of beta-blockers were similar when the trial population was weighted according to the characteristics of the NORMI cohort.
Conclusions:
Compared with the NORMI cohort, participants in BETAMI and DANBLOCK were younger, had a lower proportion of certain comorbidities, and experienced a lower risk of all-cause mortality and MI. Despite these differences, the effect of beta-blockers remained consistent when the trial population was weighted according to the NORMI cohort.
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