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Discontinuation of Beta-Blocker Therapy after Myocardial Infarction
Ki Hong Choi1, Danbee Kang2, Weon Kim3
1Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Insights
Discontinuing long-term beta-blocker therapy after myocardial infarction is safe for stable patients without heart failure. This approach is noninferior to continuing therapy for major adverse cardiovascular events.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacotherapy
Background:
- The necessity of long-term beta-blocker (BB) therapy post-myocardial infarction (MI) is uncertain in patients without left ventricular systolic dysfunction or heart failure, especially with modern reperfusion and secondary prevention strategies.
- Contemporary management of MI has evolved, prompting re-evaluation of established treatment protocols.
Purpose of the Study:
- To determine if discontinuing beta-blocker therapy beyond one year post-myocardial infarction is noninferior to continuing it in stable patients without heart failure.
- To assess the composite outcome of all-cause death, recurrent MI, or heart failure hospitalization.
Main Methods:
- An open-label, randomized, noninferiority trial involving 2540 stable patients post-MI with LVEF ≥40% and no heart failure, who had received BB therapy for at least 1 year.
- Patients were randomized 1:1 to either discontinue or continue beta-blocker therapy.
- The primary endpoint was a composite of death, recurrent MI, or heart failure hospitalization, with a noninferiority margin set at HR 1.4.
Main Results:
- A total of 2540 patients were randomized; 1246 to discontinuation and 1294 to continuation.
- At a median follow-up of 3.1 years, the 4-year event rate was 7.2% in the discontinuation group and 9.0% in the continuation group (HR 0.80; 95% CI 0.57-1.13).
- The study met its noninferiority endpoint (P=0.001), with similar rates of serious adverse events in both groups.
Conclusions:
- Discontinuation of beta-blocker therapy beyond one year post-myocardial infarction is noninferior to continuation in stable patients without heart failure.
- This finding supports a potential de-escalation of long-term beta-blocker therapy in select post-MI patients.
- The study provides crucial evidence for optimizing pharmacotherapy in cardiovascular secondary prevention.
Background:
The role of long-term beta-blocker therapy after a myocardial infarction in patients without left ventricular systolic dysfunction or heart failure is unclear in the era of contemporary coronary-artery reperfusion and secondary prevention interventions.
Methods:
We conducted an open-label, randomized, noninferiority trial at 25 centers in South Korea. Patients whose condition remained stable after a myocardial infarction, who had a left ventricular ejection fraction of at least 40% and no heart failure, and who had received beta-blocker therapy for at least 1 year after the myocardial infarction were randomly assigned in a 1:1 ratio to discontinue or to continue beta-blocker therapy. The primary end point was a composite of death from any cause, recurrent myocardial infarction, or hospitalization for heart failure. The prespecified noninferiority margin was an upper limit of the 95% confidence interval for the hazard ratio of 1.4.
Results:
A total of 2540 patients underwent randomization; 1246 were assigned to beta-blocker discontinuation and 1294 to beta-blocker continuation. The mean age of the patients was 63.2 years, and 12.8% were women. At a median follow-up of 3.1 years (interquartile range, 2.5 to 3.5), a primary end-point event had occurred in 58 patients (4-year Kaplan-Meier estimate, 7.2%) in the discontinuation group and in 74 patients (4-year Kaplan-Meier estimate, 9.0%) in the continuation group (hazard ratio, 0.80; 95% confidence interval, 0.57 to 1.13; P = 0.001 for noninferiority). The incidence of serious adverse events was similar in the two groups.
Conclusions:
Among patients who received beta-blocker therapy beyond the first year after a myocardial infarction, discontinuation of beta-blocker therapy was noninferior to continuation with respect to a composite of death from any cause, recurrent myocardial infarction, or hospitalization for heart failure. (Funded by Patient-Centered Clinical Research Coordinating Center in the Ministry of Health and Welfare, South Korea; SMART-DECISION ClinicalTrials.gov number, NCT04769362.).
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