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Regular Bleeding Risk Assessment Associated with Reduction in Bleeding Outcomes: The mAFA-II Randomized Trial - 28/09/20

Doi : 10.1016/j.amjmed.2020.03.019 
Yutao Guo, MD, PhD a, Deirdre A. Lane, PhD b, c, Yundai Chen, MD, PhD a, Gregory Y.H. Lip, MD a, b, c,
on behalf of the

mAF-App II Trial investigators

a Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China 
b Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom 
c Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark 

Requests for reprints should be addressed to Gregory YH Lip, MD, Liverpool Centre for Cardiovascular Science, William Henry Duncan Building, 6 West Derby Street, Liverpool, Merseyside L7 8TX, United Kingdom.Liverpool Centre for Cardiovascular ScienceWilliam Henry Duncan Building6 West Derby StreetLiverpoolMerseysideL7 8TXUnited Kingdom

Abstract

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% (Ptrend < .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.

El texto completo de este artículo está disponible en PDF.

Keywords : Anticoagulants, Atrial fibrillation, Bleeding, Dynamic risk assessment, HAS-BLED, Mobile health


Esquema


 Funding: This research project was funded by the National Natural Science Foundation of China (H2501) and was funded by the Health and Family Planning Commission of Heilongjiang Province, China (2017-036), and partly supported by the National Institute for Health Research Global Health Research Group on Atrial Fibrillation managed by the University of Birmingham, UK. This study was an investigator-initiated project, with limited funding by independent research and educational grants. Funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
 Conflict of Interest: GYHL: Consultant for Bayer/Janssen, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon, and Daiichi-Sankyo. Speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are directly received personally. DAL has received investigator-initiated educational grants from Bristol-Myers Squibb (BMS) and Boehringer Ingelheim; has been a speaker for Boehringer Ingelheim, Bayer, and BMS/Pfizer; and has consulted for BMS, Bayer, Boehringer Ingelheim, and Daiichi-Sankyo. Other authors: None declared.
 Authorship: All authors had access to the data and contributed to drafting the article or revising it critically for important intellectual content.


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Vol 133 - N° 10

P. 1195 - octobre 2020 Regresar al número
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