Has the introduction of direct oral anticoagulants (DOACs) in England increased emergency admissions for bleeding conditions? A longitudinal ecological study

OBJECTIVE: There is concern about long-term safety of direct oral coagulants (DOACs) in clinical practice. Our aim was to investigate whether the introduction of DOACs compared with vitamin-K antagonists in England was associated with a change in admissions for bleeding or thromboembolic complications. SETTING: 5508 General practitioner (GP) practices in England between 2011 and 2016. PARTICIPANTS: All GP practices in England with a registered population size of greater than 1000 that had data for all 6 years. MAIN OUTCOME MEASURE: The rate of emergency admissions to hospital for bleeding or thromboembolism, per 100 000 population for each GP practice in England. MAIN EXPOSURE MEASURE: The annual number of DOAC items prescribed for each GP practice population as a proportion of all anticoagulant items prescribed. DESIGN: This longitudinal ecological study used panel regression models to investigate the association between trends in DOAC prescribing within GP practice populations and trends in emergency admission rates for bleeding and thromboembolic conditions, while controlling for confounders. RESULTS: For each additional 10% of DOACs prescribed as a proportion of all anticoagulants, there was a 0.9% increase in bleeding complications (rate ratio 1.008 95% CI 1.003 to 1.013). The introduction of DOACs between 2011 and 2016 was associated with additional 4929 (95% CI 2489 to 7370) emergency admissions for bleeding complications. Increased DOAC prescribing was associated with a slight decline in admission for thromboembolic conditions. CONCLUSION: Our data show that the rapid increase in prescribing of DOACs after changes in National Institute for Health and Care Excellence guidelines in 2014 may have been associated with a higher rate of emergency admissions for bleeding conditions. These consequences need to be considered in assessing the benefits and costs of the widespread use of DOACs.