Routine screening for Helicobacter pylori (H. pylori) infection during hospitalization for acute myocardial infarction (MI) did not significantly reduce bleeding events or improve clinical outcomes, based on findings from the HELP-MI SWEDEHEART trial presented at ESC Congress 2025 and simultaneously published in JAMA.

Nearly 18,500 patients (median age 71 years/71% male) at 35 hospitals in Sweden were involved in the trial. Researchers grouped the hospitals into 18 clusters, which were randomized to provide one-year periods of routine H. pylori screening for all patients with acute MI followed by one year with usual care, or vice versa. Screening for H. pylori infection involved a bedside C-urea breath test as part of routine care during the MI hospitalization period. The primary endpoint was upper gastrointestinal bleeding.

Of the total patients tested, nearly 24% had a positive result for H. pylori infection. After approximately two years of follow-up, upper gastrointestinal bleeding occurred in 4.1% of patients in the H. pylori screening group compared with 4.6% in the control group. There were no significant differences for secondary endpoints, including all-cause death, MI and major adverse cardiac or cerebrovascular events, between the screening and control groups at the end of follow-up.

In predefined subgroup analyses, researchers observed lower risk ratios for upper gastrointestinal bleeding with H. pylori screening in patients with mild anemia and moderate-to-severe anemia. In addition, researchers noted that per-protocol analyses indicated lower instances of upper gastrointestinal bleeding in patients who were tested for H. pylori; who tested positive for H. pylori; and who tested positive for H. pylori and had confirmed eradication as compared with corresponding controls.

"Among unselected patients with acute MI in Sweden – where H. pylori infection rates appeared relatively low – routine screening did not significantly reduce the risk of upper gastrointestinal bleeding," said Principal Investigator Robin Hofmann, MD, PhD. "However, our results cannot rule out a clinically relevant benefit of H. pylori screening in populations with higher infection prevalence and in subgroups at higher risk of bleeding indicated by concomitant anemia."