RHEDAR study: Determination of the risk of gastrointestinal hemorrhage in treatment with dabigatran, acenocoumarol and rivaroxaban

• Published in: Journal of gastroenterology and hepatology 2021-10, Vol.36 (10), p.2794-2802
• Main Authors: Agudo‐Fernández, Sandra, Castaño Milla, Carlos, González Blanco, Ana, Olmos Jerez, José Antonio, Calvo Morillas, Isabel, Sancho Del Val, Lorena
• Format: Article
• Language: English
• Subjects: Acenocoumarol - adverse effects; Acetylsalicylic acid; Administration, Oral; Aged; anticoagulant therapy; Anticoagulants; Anticoagulants - adverse effects; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Bleeding; Clopidogrel; Dabigatran - adverse effects; drug therapy; Female; Fibrillation; gastrointestinal bleeding; Gastrointestinal Hemorrhage - chemically induced; Gastrointestinal Hemorrhage - drug therapy; Gastrointestinal Hemorrhage - epidemiology; Hemorrhage; Humans; Male; Patients; Retrospective Studies; risk; Risk factors; Rivaroxaban - adverse effects; Vitamin K; Warfarin - therapeutic use
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/jgh.15547

Background and Aim Atrial fibrillation is a major cause of death and disability due to stroke. Vitamin K antagonist drugs are effective for prevention, but they have a narrow therapeutic range and multiple pharmacological interactions. In recent years, new therapeutic alternatives have been searched to minimize complications. The main objective is to evaluate the risk of gastrointestinal bleeding in anticoagulated patients and compare the classic treatment with new anticoagulants. Methods We conducted a retrospective cohort study to determine the risk of gastrointestinal bleeding in patients treated with acenocoumarol/dabigatran/rivaroxaban, between 2012 and 2016. We compared the classic with the new anticoagulant group, and a multivariate logistic regression analysis was used to determinate the risk factors of gastrointestinal bleeding. Results A total of 1213 patients were selected, 52.7% male patients, a mean age of 72.6 years old (± 14.563). 73.6% had atrial fibrilation. 14.5% of patients used acetylsalicylic acid, and 4% clopidogrel. 67.2% had a high‐risk CHADS‐2 Score, and 36.9% a high‐risk HAS‐BLED Score. We determined a 5.6% (68) of gastrointestinal bleeding, without differences according to anticoagulant used. The multivariate model showed a greater risk for digestive hemorrhage in patients with a previous hemorrhagic event (odds ratio [OR] = 2.422 95% confidence interval [CI]: 1.101–5.327) and the concomitant therapy with clopidogrel (OR = 2.373 95% CI: 0.996–5.652). Conclusions No differences were found in the risk of gastrointestinal bleeding between the different anticoagulants. A previous gastrointestinal bleeding were considered independent risk factor. The HAS‐BLED score should be taken into account to make clinical decisions about to prescribe anticoagulant treatment.