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. 2020 May 30;10(5):e033357.
doi: 10.1136/bmjopen-2019-033357.

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

Ana Alfirevic  1 , Jennifer Downing  2 , Konstantinos Daras  3 , Terence Comerford  4 , Munir Pirmohamed  2 , Ben Barr  5
Affiliations

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

Ana Alfirevic et al. BMJ Open. .

Abstract

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.

Keywords: clinical pharmacology; primary care; public health.

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Conflict of interest statement

Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: all authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work (or describe if any); no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years (or describe if any); no other relationships or activities that could appear to have influenced the submitted work (or describe if any).

Figures

Figure 1
Figure 1
Trend in anticoagulant prescribing items and costs from general practitioner practices in England and the proportion of direct oral anticoagulants (DOACs) of all anticoagulants prescribed. In 2014, National Institute for Health and Care Excellence guidelines on the use of DOACs has changed.
Figure 2
Figure 2
Geographical pattern in direct oral anticoagulants (DOACs) prescribing as a proportion of all anticoagulant prescribing items in England 2011–2016 that includes changes in National Institute for Health and Care Excellence guidelines in 2014.
Figure 3
Figure 3
Estimates from the regression model showing the relative change in the rate of emergency admissions for bleeding and clotting complications associated with each additional 10% of direct oral anticoagulants (DOACs) prescribed as a proportion of all anticoagulants.
Figure 4
Figure 4
Trend in emergency admissions for bleeding conditions between 2011 and 2016 and the trend estimated from the regression model that would have been expected if direct oral anticoagulants (DOACs) had not been introduced.
See this image and copyright information in PMC

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