Regular Bleeding Risk Assessment Associated with Reduction in Bleeding Outcomes: The mAFA-II Randomized Trial

Background: The mobile atrial fibrillation application (mAFA-II) randomized trial reported that a holistic management strategy supported by mobile health reduced atrial fibrillation-related adverse outcomes. The present study aimed to assess whether regular reassessment of bleeding risk using the Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratio, Elderly, Drugs or alcohol (HAS-BLED) score would improve bleeding outcomes and oral anticoagulant (OAC) uptake. Methods: Bleeding risk (HAS-BLED score) was monitored prospectively using mAFA, and calculated as 30 days, days 31-60, days 61-180, and days 181-365. Clinical events and OAC changes in relation to the dynamic monitoring were analyzed. Results: We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64 years, 24 years, 32.5% female). Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED ≥3 decreased (11.8% vs 8.5%, P =.008), with changes in use of concomitant nonsteroidal antiinflammatory drugs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (P <.05). Among 1077 (60%) patients who had 4 bleeding risk assessments, incident bleeding events decreased significantly from days 1-30 to days 181-365 (1.2% to 0.2%, respectively, P <.001). Total OAC usage increased from 63.4% to 70.2% (P _trend <.001). Compared with atrial fibrillation patients receiving usual care (n = 1136), bleeding events were significantly lower in atrial fibrillation patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, P =.004). OAC use decreased significantly by 25% among AF patients receiving usual care, when comparing baseline to 12 months (P <.001). Conclusion: Dynamic risk monitoring 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.