Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48

BACKGROUND:The ABC (age, biomarker, clinical history)-stroke and ABC-bleeding risk scores incorporate clinical variables and cardiovascular biomarkers to estimate risk of stroke or systemic embolic events and bleeding, respectively, in patients with atrial fibrillation. These scores have been propos...

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Published in:Circulation (New York, N.Y.) N.Y.), 2019-02, Vol.139 (6), p.760-771
Main Authors: Berg, David D, Ruff, Christian T, Jarolim, Petr, Giugliano, Robert P, Nordio, Francesco, Lanz, Hans J, Mercuri, Michele F, Antman, Elliott M, Braunwald, Eugene, Morrow, David A
Format: Article
Language:English
Subjects:
Aged
Anticoagulants - therapeutic use
Atrial Fibrillation - diagnosis
Atrial Fibrillation - drug therapy
Atrial Fibrillation - epidemiology
Biomarkers, Pharmacological
Cohort Studies
Disease Progression
Embolism - epidemiology
Factor Xa Inhibitors - therapeutic use
Female
Germany - epidemiology
Hemorrhage - epidemiology
Humans
Male
Middle Aged
Pyridines - therapeutic use
Risk
Stroke - epidemiology
Thiazoles - therapeutic use
United States - epidemiology
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Summary:BACKGROUND:The ABC (age, biomarker, clinical history)-stroke and ABC-bleeding risk scores incorporate clinical variables and cardiovascular biomarkers to estimate risk of stroke or systemic embolic events and bleeding, respectively, in patients with atrial fibrillation. These scores have been proposed for routine clinical use, but their performance in external cohorts remains uncertain. METHODS:ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation—Thrombolysis in Myocardial Infarction 48) was a multinational randomized trial of the oral factor Xa inhibitor edoxaban in patients with atrial fibrillation and a CHADS2 score ≥2. We performed a nested prospective biomarker study in 8705 patients, analyzing baseline high-sensitivity troponin T (hsTnT), NT-proBNP (N-terminal B-type natriuretic peptide), and growth differentiation factor-15 (GDF-15), as well as in serial samples after 12 months. The ABC-stroke (age, prior stroke/transient ischemic attack, hsTnT, NT-proBNP) and ABC-bleeding (age, prior bleeding, hemoglobin, hsTnT, and GDF-15) scores were tested. Hazard ratios were adjusted for estimated glomerular filtration rate and the components of the CHA2DS2-VASc and HAS-BLED scores, respectively. Discrimination and reclassification were compared with these established scores. RESULTS:Median baseline hsTnT, NT-proBNP, and GDF-15 levels were 13.7 ng/L (25th–75th percentiles, 9.6–20.4 ng/L), 811 pg/mL (386–1436 pg/mL), and 1661 pg/mL (1179–2427 pg/mL), respectively. Elevated hsTnT, NT-proBNP, and GDF-15 were independently associated with higher rates of stroke or systemic embolic events, and elevated hsTnT and GDF-15 were independently associated with higher rates of major bleeding (P
ISSN:0009-7322
1524-4539
DOI:10.1161/CIRCULATIONAHA.118.038312