A common data model for oral anticoagulants-related risk of spontaneous intracranial hemorrhage

Spontaneous intracranial hemorrhage (sICH) is a major complication associated with oral anticoagulation which results in a high mortality rate, and the incidence of anticoagulant-induced sICH has increased markedly, so it is necessary to investigate the risk of anticoagulation-related sICH in a real-world setting. We aimed to investigate the incidence and risk factors of oral anticoagulant-related sICH using a common data model (CDM), and to determine whether a clinical study using the CDM would be comparable to conventional studies. After converting the various clinical codes of 12,821 patients taking oral anticoagulants, such as warfarin and non-vitamin K antagonist oral anticoagulants (NOACs), into the Observational Medical Outcomes Partnership (OMOP) CDM format, we analyzed the incidence and risk factors of sICH. sICH occurred in 0.5 % of 5,626 patients with warfarin and 0.2 % of 7,195 patients with NOAC. The mean duration of warfarin and NOACs before sICH occurrence was 251.4 ± 373.6 and 124.2 ± 135.7 days, respectively. Multivariable analysis showed significant risk factors of the sICH, such as warfarin over NOACs; hypertension; diabetes mellitus; brain tumors; and decreased duration of oral anticoagulation. NOACs demonstrated a lower risk of sICH than warfarin in a real-world setting using OMOP CDM confined to a single institution. Clinical studies using a CDM for the multicenter datasets may provide more reliable information about the risk of sICH.