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Regular bleeding risk assessment associated with reduction in bleeding outcomes: The mAFA II randomised trial
Guo Y, Lane DA, Chen Y, Lip GYH
Am J Med. 2020
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Abstract
BACKGROUND The mobile Atrial fibrillation application (mAFA-II) randomised 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 HAS-BLED score would improve bleeding outcomes and 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 analysed. RESULTS We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64, 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=0.008), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (p<0.05). Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively, p<0.001). Total OAC usage increased from 63.4% to 70.2% (ptrend<0.001). Compared to atrial fibrillation patients receiving usual care (n=1136), bleeding events were significantly lower in atrial fibrillaiton patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, p=0.004). (p<0.001). 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.
PICO Summary
Population
Patients with atrial fibrillation enrolled in the mAFA-II trial (n=1793).
Intervention
Dynamic risk monitoring on anticoagulant and bleeding events using the HAS-BLED score at four timepoints (n=1077).
Comparison
Usual care (n=1136).
Outcome
Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED >/=3 decreased (11.8% vs. 8.5%), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED >/=3. Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively). Total OAC usage increased from 63.4% to 70.2%. Compared to 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%).