- Hawkey CJ, et al. Helicobacter pylori eradication aspirin trial (HEAT): primary prevention of upper gastrointestinal ulcer bleeding evaluated in a large scale trial in UK primary care. OP044, UEG Week 2022, Vienna, Austria, 8–11 October.
The HEAT trial (NCT01506986) aimed to explore the effect of H. pylori eradication on hospitalisation for ulcer bleeding in aspirin users. “We also wanted to develop a method that could be used for other big studies, based on primary care, using routine clinical data,” Prof. Christopher Hawkey (Nottingham Digestive Diseases Centre, UK) explained.
The screening was performed between 2012 and 2017 via electronic interrogation of primary clinical practice data according to the inclusion criteria: age ≥60, daily aspirin ≤325 mg, and ≥4 prescriptions in the past year. Of the nearly 190,000 patients, who subsequently received a letter of invitation, about 30,000 had their breath tested for H. pylori. The 5,367 of those with a positive test were then randomised to receive placebo or a triple eradication treatment.
As a result, in the 10% cohort sample that underwent a second breath test, 90.7% of those treated were negative for H. pylori compared with 24% of the controls. The baseline characteristics were similar among groups. Participants were predominately men (73.9% and 73.6%), had a mean age of about 73 years, and more or less half of them were on aspirin due to coronary heart disease.
The results showed 26 hospitalisations for ulcer bleeding in the control group and 18 in the eradication arm, with a highly-significant, time-dependent violation of the proportional hazards assumption (P=0.0068) and an early separation of the curves. In the control group, the first bleeding occurred within 6 days, while in the eradication group this happened only after 525 days.
Within the first 2.5 years, the difference in hospitalisations for ulcer bleeding was significant: 17 (controls) versus 6 (eradication) with a hazard ratio of 0.35. “If we look at the second half of the study, the relationship was, if anything, reversed and there is not a significant difference between the groups,” Prof. Hawkey elaborated with regard to a non-significant hazard ratio of 1.31 for the >2.5 years part of the trial.
“In summary, H. pylori eradication protects against aspirin associated ulcer bleeding, if it occurs early on, but is probably not sustained after several years,” Prof. Hawkey said in his conclusion, pointing out that the study does not support the idea of widespread use of eradication, but eradication may be useful in case of a higher bleeding risk.