Background: Immune checkpoint inhibitors (ICIs) have been associated with an increased risk of cardiovascular and thromboembolic events. However, the incidence of cardiovascular and thromboembolic events associated with ICIs in gastroesophageal cancers is unknown.
Methods: We performed a propensity score-matched cohort study using the TriNetX Analytics Network database, which comprises de-identified data from over 130 participating healthcare institutions. Patients who received ICI and chemotherapy were compared with those who received only chemotherapy. The primary outcomes were cardiovascular events including pericarditis, myocarditis, heart failure, myocardial infarction, ischemic stroke, atrial fibrillation, conduction disorders as well as venous thromboembolism (VTE) within 1-year of ICI or chemotherapy. We matched the cohorts based on predetermined variables including demographics, metastatic disease, chemotherapy, underlying comorbidities, and the use of cardiovascular and lipid-lowering medications.
Results: We identified 1,448 patients who received ICI and chemotherapy and 11,966 patients who received chemotherapy only. After matching, 1,425 patients remained in each cohort. The mean age was 63.1 ± 12.7 years in the ICI and chemotherapy cohort and 62.9 ± 12.1 years in the chemotherapy-only cohort. ICI was associated with a higher incidence of pericarditis (45.6 vs. 30.9 cases per 1000 patient-years; HR 1.51 [95% CI 1.03-2.22]) and VTE (102.5 vs. 75.1 cases per 1000 patient-years; HR 1.40 [95% CI 1.09-1.80]). The incidence of other cardiovascular outcomes were similar between the two cohorts.
Conclusion: In this cohort study, the use of ICI and chemotherapy was associated with an approximately 40-50% increased risk of pericarditis and VTE than patients on chemotherapy only.
Keywords: Cardiovascular events; Gastroesophageal cancer; Immune checkpoint inhibitor; Venous thromboembolism.
© 2025. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.