Results of the HEAT (Helicobacter Eladictation Aspirin Trial) Randomized Study

Peptic ulcers in patients receiving aspirin are known to be associated with Helicobacter pylori infection.  It is of interest to study the effect of H. pylori eradication on aspirin-associated ulcer bleeding.
To this end, a randomized, double-blind, placebo-controlled study was conducted in 1208 primary health care centers in the UK. The study included individuals aged 60 years and older who received aspirin at a daily dose of 325 mg or less and had a positive 13C-urease breath test at screening. Of 30,166 patients who underwent an H. pylori breath test, 5,367 were positive. Patients receiving ulcerogenic or gastroprotective drugs were excluded from the study. Participants were randomly divided into 2 groups: the main group received a combination of oral clarithromycin 500 mg, metronidazole 400 mg and lansoprazole 30 mg for 1 week, and the control received oral placebo.
Subsequently, follow-up was carried out (on average, about 5 years), which consisted in the study of electronic documentation in primary and secondary care. The primary outcome measure was time to hospitalization or death due to definite or probable peptic ulcer bleeding.
There was a significant decrease in the frequency of primary adverse outcomes in the active eradication group in the first 2.5 years of follow-up compared with the control group, however, this difference was leveled after 2.5 years of follow-up.
Thus, eradication of H. pylori reduces the incidence of peptic ulcer bleeding associated with aspirin use, but this protective effect may not be sustainable in the long term.

Lancet.2022 Nov 5;400(10363):1597-1606. doi: 10.1016/S0140-6736(22)01843-8

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