Evans A, Davies M, Wise L and Shakir S.
The ROSE Specialist Cohort Event Monitoring (SCEM) study was conducted to monitor the safety and use of rivaroxaban for Stroke Prevention in patients (pts) with non-valvular AF (SPAF) and the prevention and/or treatment of Deep Vein Thrombosis and/or Pulmonary Embolism (DVT/PE). Bleeding risk has been previously estimated in various settings; this study aimed to estimate risk in secondary (2°) care real-world pts ≤ 12 weeks (wks
To estimate the incidence of major and CRNM bleeding in pts prescribed rivaroxaban for SPAF and DVT/PE indications in 2° care in England and Wales.
Pts identified through speciality groups (2013-2016), supported by UK Clinical Research Networks. Risk factors for bleeding (HAS-BLED) and bleeding outcomes were collected via detailed questionnaires completed by hospital specialists at baseline and ≥ 12 wks. Summary descriptive statistics and 12 wk incidence estimates were calculated.
Cohort consisted of 2542 pts: 965 pts with AF (38.0% of cohort; median age 76 years (yrs) [IQR 69, 83], 517 [53.6%] male), median HAS-BLED score 2 (IQR 1-3) (moderate risk of major bleeding); 1532 pts with DVT/PE (60.3% of cohort; median age 63 yrs [IQR 48, 73], 836 [54.6%] male), median HAS-BLED score 1 (IQR 0-2) (low risk of major bleeding). AF group: Rate Major + CRNM bleeding 28.2 per 100 pt yrs (95% CI 21.0, 37.1; n=51). Rate Major Bleed (MB) 5.5 (95% CI 2.6-10.1; n=10), CRNM bleeding 22.7 (95% CI 16.3-30.8; n=41). MB risk in pre-specified sites: gastrointestinal (GI) (0.2%; n=2), urogenital (UG) (0.2%; n=2), intracranial (IC) (0.2%; n=2) and all other critical organ (excluding IC) (0.1%; n=1). DVT/PE group: Rate Major + CRNM bleeding 36.2 (95% CI 29.4, 44.1; n=98). Rate MB 8.3 (95% CI 5.3, 12.5; n=23), CRNM bleeding 27.6 (95% CI 21.7, 34.6; n=75). MB risk in pre-specified sites: GI (0.7%; n=11), UG (0.3%; n=5), IC (0.1%; n=1) and all other critical organ (excluding IC) (0.0%; n=0).
The incidence of major bleeding was low and no new safety concerns were raised. Unique aspects of this study design enabled collection of highly detailed information from cardiologists, facilitating accurate calculation of risk scores and the application of clinical trial outcome definitions, in a real-word setting. Differences in methodology between this and other study designs prevents meaningful comparison.