Individual net clinical outcome with oral anticoagulation in atrial fibrillation using the ABC-AF risk scores

Ziad Hijazi; Johan Lindbäck; Jonas Oldgren; Alexander P Benz; John H Alexander; Stuart J Connolly; John W Eikelboom; Christopher B Granger; Renato D Lopes; Agneta Siegbahn; Lars Wallentin

doi:10.1016/j.ahj.2023.03.012

Individual net clinical outcome with oral anticoagulation in atrial fibrillation using the ABC-AF risk scores

Am Heart J. 2023 Jul:261:55-63. doi: 10.1016/j.ahj.2023.03.012. Epub 2023 Mar 27.

Authors

Affiliations

¹ Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. Electronic address: [email protected].
² Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
³ Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
⁴ Population Health Research Institute, Hamilton, Ontario, Canada; Department of Cardiology, Cardiology I, University Medical Center Mainz, Johannes Gutenberg-University, Mainz, Germany.
⁵ Duke Clinical Research Institute, Duke Medicine, Durham, NC.
⁶ Population Health Research Institute, Hamilton, Ontario, Canada.
⁷ Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.

PMID: 36990261
DOI: 10.1016/j.ahj.2023.03.012

Abstract

Background: Decisions on stroke prevention strategies in patients with atrial fibrillation (AF) depend on the perceived risks of stroke and bleeding with different antithrombotic treatment strategies. The study objectives were to evaluate net clinical outcome with oral anticoagulation (OAC) for the individual patient with AF and to identify clinically relevant thresholds for OAC treatment.

Methods: Patients with AF receiving OAC treatment in the randomized ARISTOTLE and RE-LY trials, with available biomarkers for calculation of ABC-AF scores at baseline, were included (n = 23,121). Observed 1-year risk on OAC was compared with predicted 1-year risk if the same patients would not have received OAC using the ABC-AF scores calibrated for aspirin. Net clinical outcome was defined as the sum of stroke and major bleeding risks.

Results: The ratio between the 1-year incidence of major bleeding and stroke/systemic embolism events ranged from 1.4 to 10.6 according to different ABC-AF risk profiles. Net clinical outcome analyses showed that in patients with an ABC-AF-stroke risk >1% per year on OAC (>3% without OAC), treatment with OAC consistently provides larger net clinical benefit than no-OAC treatment. In patients with an ABC-AF-stroke risk <1.0% per year on OAC (<3% without OAC) an individualized balancing of risks regarding OAC or no-OAC treatment is needed.

Conclusions: In patients with AF, the ABC-AF risk scores allow an individual and continuous estimate of the balance between benefits and risks with OAC treatment. This precision medicine tool therefore seems useful as decision support and visualizes the net clinical benefit or harm with OAC treatment (http://www.abc-score.com/abcaf/).

Clinical trial registration: ClinicalTrials.gov identifier NCT00412984 (ARISTOTLE) and NCT00262600 (RE-LY).

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Administration, Oral
Anticoagulants
Atrial Fibrillation* / complications
Atrial Fibrillation* / drug therapy
Atrial Fibrillation* / epidemiology
Hemorrhage
Humans
Risk Assessment
Risk Factors
Stroke* / epidemiology
Stroke* / etiology
Stroke* / prevention & control

Substances

Anticoagulants

Associated data

ClinicalTrials.gov/NCT00412984
ClinicalTrials.gov/NCT00262600