Regular reassessment of bleeding risk using the HAS-BLED score reduces bleeding outcomes in a prospective cohort: a report from the mAFA II clinical trial extension

Abstract

Abstract Background The HAS-BLED score was introduced to draw attention to modifiable bleeding risk factors and to identify patients with atrial fibrillation (AF) at high-risk of bleeding for early review and follow-up. The mAFA-II randomised trial reported that a holistic management strategy using App-based mobile Health technology support reduced AF-related adverse outcomes, compared to usual care. Objective To assess whether regular reassessment of bleeding risk using the HAS-BLED score would improve bleeding outcomes and oral anticoagulation (OAC) uptake. Methods Data for this analysis was drawn from the mAF App intervention arm. Bleeding risk (HAS-BLED score) and stroke risk (CHA2DS2-VASc score) were monitored prospectively using mAFA, and calculated during 4 periods: 1–30 days, 31–60 days, 61–180 days, and 181–365 days. Clinical events and OAC changes in relation to the dynamic monitoring and reassessments were analysed. Results We studied 1793 patients with AF (mean age 64 years, 32.5% female). The average number of re-assessments of CHA2DS2-VASc and HAS-BLED scores were 6.8 (SD 4.0) and 6.8 (4.1), respectively. Comparing baseline and 12 months, the proportion of AF patients with HAS-BLED ≥3 decreased (11.8% vs. 8.5%, p=0.008), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio (INR) contributing to the decreased proportion of patients with HAS-BLED ≥3 temporally (p<0.05). Use of non-vitamin K antagonist oral anticoagulants (NOAC), warfarin, and any antiplatelet drug was 47.1%, 13.8%, and 15.5%, respectively, at baseline. Incident bleeding events decreased significantly from 1–30 days to 181–365 days (1.2% to 0.2%, respectively; Table 1). Warfarin and NOAC use increased significantly over this period (17.9% to 18.4% and 46.4% to 51.8%, respectively). Conclusion In this clinical trial cohort, dynamic risk monitoring and reassessment using the HAS-BLED score, together with holistic App-based management using mAFA II reduced bleeding events, addressed modifiable bleeding risks and increased uptake of OACs. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Natural Science Foundation of China (H2501), NIHR Global Health Research Group on Atrial Fibrillation management