Sandeep Dhanda, Miranda Davies, Deborah Layton, Vicki Osborne and Saad AW Shakir
Background
Rivaroxaban, first approved in the EU in 2008, is one of the novel oral anticoagulants. To advance the understanding of the safety and use of rivaroxaban, a UK PASS is being conducted in primary
care as part of a risk management plan. Study objectives include characterisation of baseline risk of bleeding in patients (pts) with AF.
Objectives
To characterise baseline risk factors for bleeding in pts prescribed rivaroxaban in primary care in England.
Methods
An observational cohort study. Interim cohort identified from dispensed prescriptions of rivaroxaban in England from Dec 2011- Jul 2015. Risk factors for bleeding were collected from prescribing general practitioners (GPs) via questionnaires sent ≥3, and ≥12 months after 1st prescription issued for each pt. Summary descriptive statistics were calculated (% denominator is of interim AF cohort assuming no missing data; pts with other or multiple indications excluded).
Results
The interim evaluable 3-month AF cohort consisted of 4764 pts [median age 77 years (IQR 69-84)]; 2316 (48.7%) female). Relevant risk factors reported at baseline included: age>65 yrs (4193, 88.0%), stroke history (662, 13.9%), history of bleeding (114, 2.4%), excessive alcohol intake (85, 1.8%), uncontrolled hypertension (40, 0.8%), renal disease (38, 0.8%), medication use predisposing to bleeds (26, 0.6) and abnormal liver function (20, 0.4%). 4198 (88.2%) pts had a HAS-BLED score of 1 (3490, 73.3%) or 2 (708, 14.9%). 88 pts (1.9%) had a score of ≥3 indicating high risk of bleeding.
Conclusion
The results from this interim analysis show that the prevalence of stroke history is very common in patients with AF starting rivaroxaban, followed by a history of bleeding and excessive alcohol intake. A HAS-BLED score necessitating caution or regular review (i.e ≥3) was reported in 1.9% of the cohort. These results will be superseded after validation and follow-up are complete for the final analysis.