Dhanda S, Davies M, Roy D, Wise L and Shakir S. Presented by Alison Evans.
Clinical trials and observational studies have reported bleeding risk in patients (pts) taking rivaroxaban. A PASS was carried out as part of the RMP to monitor the safety and use of rivaroxaban using real-world primary (1°) care data in England.
To estimate the risk of major and CRNM bleeding in pts prescribed rivaroxaban for SPAF and DVT/PE in 1° care.
Pts identified from dispensed prescriptions in England (2012-2016). Detailed questionnaires sent to general practitioners (GPs) at ≥3 and ≥12 months of observation collected information on risk factors for bleeding (HAS-BLED) and bleeding outcomes. Summary descriptive statistics and 12-month risk estimates were calculated.
Cohort = 17546 pts: 10225 pts with AF (58.3% of cohort, median age 78 years (yrs) [IQR 70-84], 5253 (51.4%) male); 5959 pts with DVT/PE (34.0 % of cohort, median age 66 yrs [IQR 50-78]; 3197 (53.6%) female). In both groups, the median HAS-BLED score was 1 (IQR 1-2, 0-1, respectively) reflecting a low risk of major bleeding.
AF group: Risk Major + CRNM bleeding 8.3% ([95% CI 7.8, 8.9]; n=825). Risk Major bleed (MB) 2.4% ([95% CI 2.1, 2.7]; n=239), CRNM bleeding 6.0% ([95% CI 5.5, 6.4]; n=592). MB further stratified by site: gastrointestinal (GI) (1.2%; n=117), urogenital (UG) (0.1%; n=13), intracranial (IC) (0.4%; n=42), all other critical organ (excluding IC) (0.3%; n=26) and all non-critical organ sites (0.4%; n=44).
DVT/PE group: Risk Major + CRNM bleeding 4.2% ([95% CI 3.7, 4.7]; n=240). Risk MB 1.4% ([95% CI 1.1, 1.7]; n=82), CRNM bleeding 2.8% ([95% CI 2.4, 3.3]; n=162). MB further stratified by site: GI (0.7%; n=38), UG (0.3%; n=18), IC (0.2%; n=12), all other critical organ (excluding IC) (0.1%; n=4) and all non-critical organ sites (0.2%; n=10).
For the primary outcome of major bleeding, the estimates of risk in the AF and DVT/PE rivaroxaban user populations were overall low and consistent with those estimated from clinical trial data. Differences in methodologies and analysed study populations prevent meaningful comparisons with other studies. This study design has unique strengths, including the collection of timely, granular data directly from prescribing GPs, however selective reporting of outcomes and selection bias might be present, and should be considered when interpreting results.