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Helicobacter pylori Screening After Acute Myocardial Infarction: The Cluster Randomized Crossover HELP-MI SWEDEHEART
Robin Hofmann1, Stefan James2,3, Martin O Sundqvist1
1Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
Insights
Routine screening for Helicobacter pylori in myocardial infarction patients did not significantly lower upper gastrointestinal bleeding risk. Further research is needed to explore potential benefits in specific patient subgroups.
Area of Science:
- Cardiology
- Gastroenterology
- Infectious Disease Epidemiology
Background:
- Upper gastrointestinal bleeding is a significant complication following myocardial infarction.
- Helicobacter pylori infection is a known risk factor for gastrointestinal issues.
Purpose of the Study:
- To evaluate if routine Helicobacter pylori screening during myocardial infarction hospitalization reduces bleeding events.
- To assess the impact of H. pylori screening on clinical outcomes in myocardial infarction patients.
Main Methods:
- A nationwide, cluster randomized, crossover trial involving 35 Swedish hospitals.
- Patients with acute myocardial infarction were assigned to either routine H. pylori screening or usual care.
- Data collected from clinical registries and national health data, with follow-up until January 2025.
Main Results:
- No significant reduction in upper gastrointestinal bleeding was observed in the H. pylori screening group (rate ratio, 0.90; P=.18).
- A potential benefit was noted in subgroups with moderate to severe anemia (P for interaction=.03).
- H. pylori was detected in 23.6% of patients tested during the screening periods.
Conclusions:
- Routine H. pylori screening in unselected acute myocardial infarction patients did not significantly decrease the risk of upper gastrointestinal bleeding.
- The findings suggest that routine screening may not be beneficial for all patients, but subgroup effects warrant further investigation.
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.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05024864.
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