Bleeding Complications in Patients on New Oral Anticoagulants for Venous Thromboembolism in Kenya

Abstract Background: The purpose of this study is to determine the rates of bleeding associated with NOAC use. Methods: Patients diagnosed with venous thromboembolism (VTE) and treated with NOACs at a tertiary referral hospital in Kenya from January 2014 to December 2019 were recruited. They were followed up from commencement of oral anticoagulation to completion of therapy, the first major bleed, clinically relevant non-major bleed (CRNM), or minor bleeding. Data on bleeding was obtained from the hospital database and through telephone interviews. Unadjusted rates of the first major bleeding event or clinically relevant non-major bleeding (CRNM) were calculated as the number of bleeding events per 100 patient-years Results: Two hundred forty-three patients with VTE were recruited. 222(91.4%) were initiated on rivaroxaban, 12(4.9%) on dabigatran, 9(3.7%) on apixaban with a median follow-up of 213(119,477) days. The median age of the patients was 57(45, 71) years. A total of 64 bleeding events were identified in 41(16.9%) patients, 18.8 % were major, 17.2 % were clinically relevant non-major (CRNM), and 64.1 % were minor. The incidence rate for bleeding events was 22.1 per 100 patient-years. Gastrointestinal (GIT) bleeding was the most common major bleeding site. There were more females with bleeding events (70.7%) compared to males. Conclusions: In our cohort, most bleeding events were minor, with the GIT being the most common site of major bleeding and menorrhagia being the commonest cause of bleeding. Females had more major and CRNM than men.