NEW ORLEANS — Patients who had a myocardial infarction (MI) can safely stop taking beta-blocker medications to lower blood pressure a year or more after the heart attack, provided they do not have atrial fibrillation, heart failure (HF), or other cardiovascular risk factors, a clinical trial in South Korea has found.

“The SMART-DECISION trial is the first randomized study to demonstrate the noninferiority of beta-blocker discontinuation in post-myocardial infarction patients without left ventricular systolic dysfunction or heart failure,” Joo Yong Hahn, MD, PhD, chair of cardiology at Samsung Medical Center in Seoul, South Korea, told attendees at the American College of Cardiology (ACC) Scientific Session 2026.

The results were published simultaneously in The New England Journal of Medicine.

From April 2021 to April 2023, Hahn and colleagues randomized 2540 patients (mean age, 63.2 years; 12.8% women) across 25 sites in South Korea to continue or stop beta-blockers. All patients had had an MI and had been on beta-blockers for at least 1 year, had a left ventricular ejection fraction of at least 40%, and had no diagnosis of HF. The median time from MI to trial randomization was 4.7 years, Hahn said.

Trial Results

The primary composite endpoint of death, MI, or hospitalization for HF did not differ significantly between the two study groups, Han said. At 4 years after randomization, the primary endpoint occurred in 9% of the continuation group and 7.2% of the discontinuation group (hazard ratio [HR], 0.8; 95% CI, 0.57-1.13; P for noninferiority = .001).

Likewise, similarities were observed across a host of secondary endpoints, including recurrent MI; a composite of death from a cardiovascular cause, recurrent MI, or hospitalization for HF; and atrial fibrillation occurrence, Hahn said.

The subgroup analysis showed that continuation of beta-blockers may benefit women more so than discontinuation, Hahn said. Women in the discontinuation group had an event rate of 17.1% vs 10% in the continuation group (HR, 1.95; 95% CI, 0.65-5.82).

However, Hahn noted women comprised a small proportion of the trial population. “Subgroup analyses should be considered exploratory and hypothesis-generating, and firm conclusions regarding the safety of beta-blocker discontinuation in these subgroups should be avoided,” he said.

One limitation of the trial is that it does not “define the optimal or earliest time point” for discontinuing beta-blockers after an MI. “Accordingly,” Hahn added, “the findings may not be generalizable to higher-risk patients early after MI or to populations with greater comorbidity burden.”

He said the SMART-DECISION investigators are conducting an individual patient data meta-analysis combining their data with those from the previously published ABYSS study, which found discontinuation of beta-blockers in a stable post-MI population did not provide an equivalent benefit to continuation.

Hahn told Medscape Medical News that the SMART-DECISION investigators encountered no resistance to discontinuing beta-blockers from either providers or patients.

“Actually, all the patients in the discontinuation group preferred discontinuation,” he said. “Most patients want to reduce their pill count. In real practice, reducing pill count is not difficult.”

He did not consider the trial finding practice-changing. “It’s a little bit early,” Hahn said. “Our trial demonstrated the noninferiority of discontinuing beta-blockers in stable post-MI patients, but this is the first and only trial. We need more evidence, but it is a very good first step for the future of real-world practice.”

Dealing With ‘Overwhelming’ Pill Burden

Nicole Martin Bhave, MD, a cardiologist at the University of Michigan in Ann Arbor, Michigan, who was not involved with the study, said the SMART-DECISION findings provide context for post-MI therapy in stable patients. “One of the things that I think about when I see a patient with a first myocardial infarction is the sheer number of pills that we’re putting them on,” she said.

“It’s overwhelming for them,” Bhave added. “I think this study demonstrated in a more definitive fashion than the ABYSS study that it is safe for patients with lower ejection fraction and no atrial fibrillation to stop that beta-blocker.”

During a discussion of the trial at ACC, Patrick O’Gara, MD, cardiology chair at Brigham and Women’s Hospital Heart and Vascular Center in Boston, said SMART-DECISION was “well-designed, well-executed, and well-reported,” and was noteworthy for exceeding its enrollment targets.

“This adds to the growing body of evidence around the routine use of beta-blockers following uncomplicated myocardial infarction in patients who have undergone revascularization and are treated with high-intensity lipid-lowering therapy, antiplatelet therapy, etc,” said O’Gara, who was not involved with the study.

However, he questioned the investigators’ use of an HR of 1.4 to determine noninferiority of discontinuation vs continuation. “That drives the statistical analysis and shows a very robust difference between the groups,” O’Gara said.

In response, Hahn noted that randomized clinical trials of this nature typically use a hazard of 1.3 or 1.4 and that the SMART-DECISION investigators opted for the higher threshold to err on the side of caution.

The SMART-DECISION trial was funded by the government of South Korea. Hahn reported having financial relationships with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, Abbott Structural, Baylis Medical and Phillips Healthcare. Bhave reported receiving grant funding from Rednvia. O’Gara reported having no relevant relationships to disclose.

Richard Mark Kirkner is a medical journalist based in Philadelphia.