Introduction
Patients (pts) with inflammatory bowel disease (IBD) have a significantly higher risk of venous thromboembolic events (VTEs) compared to the general population [1]. Thromboprophylaxis (TP) is recommended for patients with IBD during all-cause hospitalization [2]. Evidence supporting this practice in the clinical context of IBD is scarce. This retrospective, real-world, single-center study aims to evaluate the effectiveness and safety of TP in preventing VTEs in a large cohort of hospitalized patients with IBD. The secondary endpoint of the study was to measure adherence to the TP prescription.
Aims & Methods
Disease-related real-world data were retrospectively collected from the Hospital Information System using automated data extraction strategies and through the implementation of a patient-centred data repository (the IBD Data Mart) [3]. The study population was identified from the medical records of patients who met the following inclusion criteria during 2020-2023: hospitalized adult patients (aged ≥18 years) diagnosed with Crohn's disease (CD) (ICD9-CM diagnosis codes 555) or ulcerative colitis (UC) (ICD9-CM diagnosis codes 556). Variables of interest, including demographics, comorbidities, surgery procedures, and treatment information, were collected using data extraction strategies. Specific ETL (Extract, Transform, Load) procedures were implemented to automatically retrieve data from heterogeneous data sources: data were acquired from a structured data source or extracted using clinically-validated text mining techniques from an unstructured data source. We assessed the use of anticoagulant treatments in this setting and during hospitalization. The TP included one of the following therapeutic protocols: low-molecular-weight heparin (LMWH) at a variable dose of 4000 to 8000 IU once daily, fondaparinux 2.5-3.5 mg/day, or calciparin at a dosage of up to 5000 IU twice daily. Patients were divided into two groups: patients with or without TP. Incidence of VTEs was assessed, also based on IBD type and hospitalization.
Results
Of the 1359 identified pts (42% with UC), 724 (53.3%) were treated with anticoagulant therapy during hospitalization. 79 pts (5.8%) presented a VTE. 259 pts were already in treatment with anticoagulant or antiplatelet therapy before hospitalization. 472 pts started anticoagulant treatment during hospitalization (472/1101, 42.9%). Among them, 431 (91.3%) began TP immediately after hospitalization, and 34 (7.2%) were excluded from the analysis because they were treated with a therapeutic dose of anticoagulant immediately after hospitalization, meaning they already had a VTE. Therefore, 1067 patients were evaluated for the efficacy of TP in preventing VTEs during hospitalization. Our results showed that TP is almost significantly effective in reducing VTE episodes (p=0.053). Regarding safety, we did not observe significant differences in the need for blood transfusions between patients treated or not treated with TP (p=0.37). Furthermore, TP interruption was rare, as only 28 patients (6.5%) discontinued treatment.
Conclusion
TP is effective in a real-world cohort of hospitalized patients with IBD in reducing VTEs. It is also a safe procedure as it does not increase the risk of severe bleeding requiring blood transfusions, and treatment discontinuation is an infrequent event. However, the rate of TP in our cohort is still suboptimal, and strategies to significantly implement this practice are recommended to reduce the occurrence of VTEs further.
References
[1] Papa A, et al. Prevention and treatment of venous thromboembolism in patients with IBD: a trail still climbing. Inflamm Bowel Dis. 2015 May;21(5):1204-13.
[2] Olivera PA et al. International consensus on preventing venous and arterial thrombotic events in patients with inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2021 Dec;18(12):857-873.
[3] Damiani A, et al. Building an artificial intelligence laboratory based on real-world data: the experience of Gemelli generator. Front Comput Sci. 2021;3.
