SMART-DECISION Trial Shows Beta-Blocker Discontinuation Safe for Low-Risk Post-MI Patients
Key Insights
The SMART-DECISION trial demonstrated that discontinuing beta-blockers 1 year after heart attack was noninferior to continued use in stable patients without heart failure.
The randomized trial included 2,540 patients and found the primary endpoint occurred in 7.2% of discontinuation group versus 9% of continuation group over 3.1 years median follow-up.
This represents the first randomized study to support beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure.
Stable patients without heart failure can safely discontinue beta-blockers one year after a heart attack without increasing their risk of death, recurrent myocardial infarction, or heart failure hospitalization, according to results from the landmark SMART-DECISION trial presented at the American College of Cardiology (search) Scientific Session and simultaneously published in The New England Journal of Medicine.
The open-label, randomized noninferiority trial included 2,540 patients with a mean age of 63 years (13% women) who were stable one year after MI, had no heart failure or systolic dysfunction, and had been receiving beta-blocker therapy since their cardiac event. Patients were randomly assigned to either continue or discontinue their beta-blocker treatment.
First Randomized Evidence for Beta-Blocker Discontinuation
"The SMART-DECISION trial is the first randomized study to demonstrate the noninferiority of beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure," said Joo-Yong Hahn, MD, a cardiologist at Samsung Medical Center in Seoul, South Korea, during the press conference.
The study addresses a significant gap in contemporary cardiology practice, where many stable post-MI patients remain on beta-blockers for years solely because of their prior heart attack, despite potential adverse effects and medication burden. While beta-blockers remain foundational therapy when heart failure or reduced left ventricular ejection fraction is present, recent evidence suggests limited benefit in patients without reduced LVEF.
Primary Endpoint Results
At a median follow-up of 3.1 years, the primary endpoint of all-cause death, recurrent MI, or heart failure hospitalization occurred in 7.2% of patients in the discontinuation group compared to 9% in the continuation group (HR = 0.8; 95% CI, 0.57-1.13; P for noninferiority = .001). A per-protocol analysis confirmed these results.
Secondary outcomes showed no significant differences between groups, except for a notably higher rate of stroke in the continuation group (1.8% versus 0.7%; HR = 0.43; 95% CI, 0.19-0.99). Adverse event rates were similar between both treatment arms.
Clinical Implications and Limitations
The findings suggest that in appropriately selected patients who survived a heart attack and do not have heart failure or left ventricular systolic dysfunction, routine continuation of beta-blockers indefinitely may not be necessary. For stable patients several years out from a heart attack, discontinuation can be considered through shared decision-making with monitoring of blood pressure and heart rate.
"For patients with beta-blocker-related side effects - fatigue, dizziness, bradycardia, hypotension - the case for discontinuation is even stronger," Hahn noted.
However, the researchers emphasized important limitations. The trial enrolled a stabilized and selected post-MI population with randomization occurring at a late phase after MI, so it does not define the optimal or earliest time point when beta-blocker discontinuation is safe. The findings may not be generalizable to higher-risk patients early after MI or populations with greater comorbidity burden.
Women and patients with mildly reduced LVEF comprised only a small proportion of the trial population, making subgroup analyses exploratory and hypothesis-generating rather than definitive for these populations.