Rate and associated factors of Novel oral anticoagulant-induced bleeding in patients with non-valvular atrial fibrillation in a university affiliated hospital in Kuala Lumpur, Malaysia

Introduction: Novel oral anticoagulants (NOACs) are used to for stroke prevention among patients with non-valvular atrial fibrillation (NVAF). Bleeding events, however, complicate their use. There is sparse information on the rate and the factors associated with NOAC-induced bleeding events in Malaysian patients with NVAF. Objectives: This study aims to determine the rate and factors associated with bleeding events among patients with NVAF receiving dabigatran or rivaroxaban therapy for stroke prevention. Study Design: This is an observational study where data were collected retrospectively. Methods: The demographic and clinical data of patients with NVAF, aged 18 years or older, receiving dabigatran or rivaroxaban from 2010 to 2013 at the University of Malaya Medical Centre in Malaysia were extracted from electronic medical records. The main outcome measure is the occurrence of a bleeding event which was extracted from documented patient self-reports during routine outpatient visits, records of ward or Department of Emergency admissions at UMMC or referral letters from other healthcare centers to UMMC. Bleeding events were classified as major, clinically relevant non major bleeding and minor bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. Data were analyzed using Mann Whitney, Chi-square or binary logistic regression tests where applicable. Results: During a median follow-up period of 23 months (range 3 and 45 months), 45 (20%) from a total of 220 patients recruited experienced bleeding complications. Among these patients, 19 (9%) patients had major bleeding events including four fatal cases. The associated factors of any bleeding events include advanced age of 75 years or above, congestive heart failure and concomitant use of angiotensin converting enzyme inhibitors (ACEIs). Conclusions: NOAC-induced major bleeding episodes were infrequent but carried a high fatality risk. Interventional programs for bleeding prevention should target older patients, patients with congestive heart failure and those receiving ACEIs.