HAS-BLED and ORBIT high-risk categories significantly predicted adjudicated major bleeding (HR 1.62 and 1.83), while adding time in therapeutic range improved the predictive performance of other scores.
Observational (n=3,551)
Yes
Does incorporating time in therapeutic range (TTR) improve the predictive performance of ORBIT, ATRIA, and HEMORR2HAGES bleeding risk scores in warfarin-treated patients with non-valvular atrial fibrillation?
Incorporating time in therapeutic range (TTR) into contemporary bleeding risk scores like ORBIT and ATRIA significantly improves their ability to predict major bleeding in patients with atrial fibrillation on vitamin K antagonists.
Effect estimate: HR 1.62 (95% CI 1.06-2.48)
p-value: p=0.026
Bleeding risk represents a major concern in anticoagulated patients with atrial fibrillation (AF). Several bleeding prediction scores have been described: HAS-BLED, ATRIA, HEMORR2HAGES and ORBIT. Of these, only HAS-BLED considers quality of anticoagulation control amongst vitamin K antagonist (VKA) users. We hypothesised that predictive value of bleeding risk scores other than HAS-BLED could be improved incorporating time in therapeutic range (TTR) in warfarin-treated patients. Of the 127 adjudicated major bleeding events, 21.3% of events occurred in 'low-risk' HAS-BLED category (1.8 per 100 patient-years), compared to higher proportions (≥50% of events; ~2.5 per 100 patient-years) in 'low-risk' categories for other scores. Only the 'low-risk' HAS-BLED category was associated with the absence of investigator-defined major bleeding events (OR: 1.46;95% CI: 1.00-2.15). 'High' or 'medium/high' risk categories for the HAS-BLED (p = 0.023) or ORBIT (p = 0.022) scores, respectively, conferred significant risk for adjudicated major bleeding events. On Cox regression analysis, adjudicated major bleeding was associated only with HAS-BLED (HR: 1.62;95% CI: 1.06-2.48) and ORBIT (HR: 1.83;95% CI: 1.08-3.09) 'high-risk' categories. Adding 'labile INR' (TTR < 65%) to ORBIT, ATRIA and HEMORR2HAGES significantly improved their reclassification and discriminatory performances. In conclusion, HAS-BLED categorised adjudicated major bleeding events in low-risk and high-risk patients appropriately, whilst ORBIT and ATRIA categorised most major bleeds into their 'low-risk' patient categories. Adding TTR to ORBIT, ATRIA and HEMORR2HAGES led to improved predictive performance for major bleeding.
Proietti et al. (Tue,) conducted a observational in Non-valvular atrial fibrillation (n=3,551). HAS-BLED score (high risk category) vs. Low risk category was evaluated on Adjudicated major bleeding events (HR 1.62, 95% CI 1.06-2.48, p=0.026). HAS-BLED and ORBIT high-risk categories significantly predicted adjudicated major bleeding (HR 1.62 and 1.83), while adding time in therapeutic range improved the predictive performance of other scores.