Key take-aways
- Helicobacter pylori infection is associated with increased risk of upper gastrointestinal bleeding and is common in patients with cardiovascular disease.
- The HELP-MI SWEDEHEART trial investigated whether routine screening for H. pylori infection during hospitalisation for myocardial infarction reduces upper gastrointestinal bleeding.
- Routine H. pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding across all participants; however, it may be beneficial in certain patients at high risk of bleeding.
Madrid, Spain – 1 September 2025: Routine Helicobacter pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding in patients hospitalised for myocardial infarction (MI), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025 and simultaneously published in JAMA (The Journal of the American Medical Association).1
In patients after acute MI, potent antithrombotic treatments have had a considerable impact on reducing further ischaemic events; however, antithrombotic treatments are associated with an increased risk of bleeding, particularly from the upper gastrointestinal tract. H. pylori infection has been proposed as a potential target to help reduce the risk of upper gastrointestinal bleeding. Principal Investigator of the HELP-MI SWEDEHEART trial, Doctor Robin Hofmann from the Karolinska Institute, Stockholm, Sweden, explained: "H. pylori infection is associated with a markedly increased risk of upper gastrointestinal bleeding and is highly prevalent among patients with cardiovascular disease.2 We conducted the HELP-MI SWEDEHEART trial in a real-world setting to determine if systematic H. pylori screening could reduce upper gastrointestinal bleeding and improve outcomes after MI."
The open-label, cluster randomised crossover, registry-based HELP-MI SWEDEHEART trial was conducted at 35 hospitals in Sweden. The hospitals were grouped into 18 clusters, which were randomised to 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 13C-urea breath test as part of routine care during the MI hospitalisation period. Eradication therapy was prescribed to patients diagnosed with H. pylori infection. The primary endpoint was upper gastrointestinal bleeding analysed in the intention-to-treat population involving all individuals with an MI at participating sites during the trial period.
A total of 18,466 patients were included. The median age was 71 years, 28.9% were females and 24.7% reported proton pump inhibitor use at admission. Of the total tested, 23.6% had a positive result for H. pylori infection.
After a median follow-up of 1.9 years, there was no significant difference in upper gastrointestinal bleeding, which occurred in 4.1% of patients in the H. pylori screening group and 4.6% in the control group (rate ratio 0.90; 95% confidence interval [CI] 0.77 to 1.05; p=0.18).
Predefined subgroup analyses indicated lower risk ratios for upper gastrointestinal bleeding with H. pylori screening vs. controls in patients with mild anaemia (rate ratio 0.64; 95% CI 0.42 to 0.98) and moderate-to-severe anaemia (rate ratio 0.44; 95% CI 0.23 to 0.87).
Of all the patients with MI hospitalised during the trial period at units assigned to routine screening, 70.1% actually underwent H. pylori testing. Per-protocol analyses indicated lower upper gastrointestinal bleeding in patients who were tested for H. pylori (hazard ratio [HR] 0.84; 95% CI 0.65 to 1.08), who tested positive for H. pylori (HR 0.47; 95% CI 0.22 to 1.01) and who tested positive for H. pylori and had confirmed eradication (HR 0.49; 95% CI 0.23 to 1.06) compared with corresponding controls.
There were no significant differences for secondary endpoints at the end of follow-up, including all-cause death, MI and major adverse cardiac or cerebrovascular events.
Concluding, Doctor Hofmann said: "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. 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 anaemia."
