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Helicobacter pylori Screening After Acute Myocardial Infarction The Cluster Randomized Crossover HELP-MI SWEDEHEART Trial

Hofmann, Robin ; James, Stefan ; Sundqvist, Martin O. ; Wärme, Jonatan ; Angerås, Oskar ; Alfredsson, Joakim ; Erlinge, David LU orcid ; Arefalk, Gabriel ; Arstad, Göran and Blomberg, Simon , et al. (2025) In JAMA 334(13). p.1160-1169
Abstract

IMPORTANCE Upper gastrointestinal bleeding is common after myocardial infarction. OBJECTIVE To determine whether routine screening for Helicobacter pylori infection during hospitalization for myocardial infarction reduces bleeding events and improves clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS A nationwide, open-label, 2-period, 2-sequence, cluster randomized, crossover clinical trial using a clinical registry for study population definition and data collection merged with national Swedish health data registries. From November 17, 2021, through January 17, 2024, thirty-five Swedish hospitals grouped into 18 clusters were randomized to a sequence of 1 year with routine H pylori screening of all patients with acute myocardial... (More)

IMPORTANCE Upper gastrointestinal bleeding is common after myocardial infarction. OBJECTIVE To determine whether routine screening for Helicobacter pylori infection during hospitalization for myocardial infarction reduces bleeding events and improves clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS A nationwide, open-label, 2-period, 2-sequence, cluster randomized, crossover clinical trial using a clinical registry for study population definition and data collection merged with national Swedish health data registries. From November 17, 2021, through January 17, 2024, thirty-five Swedish hospitals grouped into 18 clusters were randomized to a sequence of 1 year with routine H pylori screening of all patients with acute myocardial infarction followed by a washout period of 2 months before crossing over to 1 year with usual care or vice versa. Patients were followed up until January 17, 2025. INTERVENTION Routine addition of H pylori screening by urea breath test to standard care in all patients hospitalized for myocardial infarction during the screening periods. MAIN OUTCOME AND MEASURE Upper gastrointestinal bleeding, analyzed by a negative binomial model in the intention-to-treat population. RESULTS A total of 18 466 patients (median age, 71 years [IQR, 61-79], 13 138 males [71%]) with myocardial infarction were followed up: 9245 during the screening periods and 9221 during the nonscreening periods. At admission, 2284 during the screening periods and 2275 during the nonscreening periods (both 24.7%) reported proton pump inhibitor use. During screening periods, 6480 patients (70%) had undergone testing, of those 1532 (23.6%) tested positive for H pylori. After a median follow-up of 1.9 years, 299 patients in the screening group (incidence rate, 16.8 events per 1000 person-years; cumulative hazard at 3 years, 4.1%) and 336 in the usual care group (incidence rate, 19.2 events per 1000 person-years; cumulative hazard at 3 years, 4.6%) experienced the primary end point of upper gastrointestinal bleeding (rate ratio [RR], 0.90; 95% CI, 0.77-1.05; P = .18). Predefined nonmultiplicity adjusted subgroup analyses showed a heterogeneous intervention effect; for no anemia (RR, 0.98; 95% CI, 0.80-1.21), mild anemia (RR, 0.64; 95% CI, 0.42-0.98), and moderate to severe anemia (RR, 0.44; 95% CI, 0.23-0.87; P for interaction = .03). CONCLUSIONS AND RELEVANCE Among unselected patients with acute myocardial infarction, routine H pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding.

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published
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JAMA
volume
334
issue
13
pages
10 pages
publisher
American Medical Association
external identifiers
  • scopus:105018029108
  • pmid:40887995
ISSN
0098-7484
DOI
10.1001/jama.2025.15047
language
English
LU publication?
yes
id
478a095f-2c60-427c-a977-ee71e77f09be
date added to LUP
2025-11-24 15:03:35
date last changed
2025-11-25 03:22:52
@article{478a095f-2c60-427c-a977-ee71e77f09be,
  abstract     = {{<p>IMPORTANCE Upper gastrointestinal bleeding is common after myocardial infarction. OBJECTIVE To determine whether routine screening for Helicobacter pylori infection during hospitalization for myocardial infarction reduces bleeding events and improves clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS A nationwide, open-label, 2-period, 2-sequence, cluster randomized, crossover clinical trial using a clinical registry for study population definition and data collection merged with national Swedish health data registries. From November 17, 2021, through January 17, 2024, thirty-five Swedish hospitals grouped into 18 clusters were randomized to a sequence of 1 year with routine H pylori screening of all patients with acute myocardial infarction followed by a washout period of 2 months before crossing over to 1 year with usual care or vice versa. Patients were followed up until January 17, 2025. INTERVENTION Routine addition of H pylori screening by urea breath test to standard care in all patients hospitalized for myocardial infarction during the screening periods. MAIN OUTCOME AND MEASURE Upper gastrointestinal bleeding, analyzed by a negative binomial model in the intention-to-treat population. RESULTS A total of 18 466 patients (median age, 71 years [IQR, 61-79], 13 138 males [71%]) with myocardial infarction were followed up: 9245 during the screening periods and 9221 during the nonscreening periods. At admission, 2284 during the screening periods and 2275 during the nonscreening periods (both 24.7%) reported proton pump inhibitor use. During screening periods, 6480 patients (70%) had undergone testing, of those 1532 (23.6%) tested positive for H pylori. After a median follow-up of 1.9 years, 299 patients in the screening group (incidence rate, 16.8 events per 1000 person-years; cumulative hazard at 3 years, 4.1%) and 336 in the usual care group (incidence rate, 19.2 events per 1000 person-years; cumulative hazard at 3 years, 4.6%) experienced the primary end point of upper gastrointestinal bleeding (rate ratio [RR], 0.90; 95% CI, 0.77-1.05; P = .18). Predefined nonmultiplicity adjusted subgroup analyses showed a heterogeneous intervention effect; for no anemia (RR, 0.98; 95% CI, 0.80-1.21), mild anemia (RR, 0.64; 95% CI, 0.42-0.98), and moderate to severe anemia (RR, 0.44; 95% CI, 0.23-0.87; P for interaction = .03). CONCLUSIONS AND RELEVANCE Among unselected patients with acute myocardial infarction, routine H pylori screening did not significantly reduce the risk of upper gastrointestinal bleeding.</p>}},
  author       = {{Hofmann, Robin and James, Stefan and Sundqvist, Martin O. and Wärme, Jonatan and Angerås, Oskar and Alfredsson, Joakim and Erlinge, David and Arefalk, Gabriel and Arstad, Göran and Blomberg, Simon and Fröbert, Ole and Hambraeus, Kristina and Hellström, Per M. and Lauermann, Jörg and Lidin, Matthias and Lindhagen, Lars and Mourtzinis, Georgios and Schoede, Carolina and Thunström, Erik and Voldberg, Birgitta and Wagner, Henrik and Östlund, Ollie and Jernberg, Tomas and Bäck, Magnus}},
  issn         = {{0098-7484}},
  language     = {{eng}},
  number       = {{13}},
  pages        = {{1160--1169}},
  publisher    = {{American Medical Association}},
  series       = {{JAMA}},
  title        = {{Helicobacter pylori Screening After Acute Myocardial Infarction The Cluster Randomized Crossover HELP-MI SWEDEHEART Trial}},
  url          = {{http://dx.doi.org/10.1001/jama.2025.15047}},
  doi          = {{10.1001/jama.2025.15047}},
  volume       = {{334}},
  year         = {{2025}},
}