Overview

• The HELP-MI SWEDEHEART trial enrolled 18,466 patients across 35 hospitals using an open-label, cluster randomized crossover design with a median 1.9-year follow-up.
• Upper gastrointestinal bleeding occurred in 4.1% with screening versus 4.6% with usual care (rate ratio 0.90; 95% CI 0.77–1.05; p=0.18).
• Among units assigned to screening, 70.1% of patients were tested, and 23.6% of those tested were H. pylori positive.
• Predefined subgroup analyses suggested lower bleeding risk in patients with mild anemia (rate ratio 0.64) and moderate-to-severe anemia (rate ratio 0.44).
• Per-protocol trends favored testing and eradication but confidence intervals largely crossed 1.0, secondary outcomes were unchanged, and investigators said routine universal screening is not supported in similar settings.