The most commonly used and validated risk scores are CHADS 2 (congestive heart failure, hypertension, age ≥75 years, diabetes, and stroke or transient ischemic attack (TIA) ) and CHA 2DS 2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 or ≥75 years, diabetes mellitus, and stroke, TIA or thromboembolism –vascular disease, and sex category ), which are based on clinical variables. 1 - 3 Current risk stratification schemes rely on a combination of demographic and clinical characteristics to determine the probability of thromboembolism.
#ENGAGE AF TIMI 48 REGISTRATION#
Trial Registration Identifier: NCT00781391Ītrial fibrillation (AF) predisposes patients to an increased risk of embolic stroke and is associated with higher rates of stroke and mortality compared with sinus rhythm. Incorporation of biomarkers into clinical decision making to define therapeutic management in AF warrants consideration. When added to the CHA 2DS 2-VASc score, the biomarker score significantly enhanced prognostic accuracy by improving the C statistic from 0.586 (95% CI, 0.565-0.607) to 0.708 (95% CI, 0.688-0.728) ( P < .001) and reclassification with a net reclassification improvement of 59.4% ( P < .001).Ĭonclusions and Relevance A prototype multimarker risk score significantly enhanced risk assessment for stroke, systemic embolic events, or death compared with traditional clinical risk stratification. The multimarker risk score identified a more than 15-fold gradient of risk after adjustment for CHA 2DS 2-VASc score. After adjustment for the CHA 2DS 2-VASc score, each biomarker was associated with a 2.8-fold to 4.2-fold gradient of risk comparing the highest vs lowest concentrations across groups of increasing concentrations ( P < .001 for trend for each). Results Of the 5002 patients enrolled in the biomarker substudy of the ENGAGE AF-TIMI 48 trial, 4880 patients (97.6%) had all 3 biomarkers available at randomization (1820 were women median age, 71 years). Main Outcomes and Measures Risk score and clinical outcomes based on cardiac troponin I, N-terminal pro-B-type natriuretic peptide, and d-dimer levels at baseline. A multimarker risk score was developed to determine the probability of stroke, systemic embolic events, or death by assigning tiered points for higher concentrations of the biomarkers. Cardiac troponin I, N-terminal pro-B-type natriuretic peptide, and d-dimer levels were measured at baseline. This prespecified subanalysis was performed in 4880 patients enrolled at randomization in the biomarker substudy. Objective To develop and test a cardiovascular biomarker score for indication of risk in patients with AF.ĭesign, Setting, and Participants The ENGAGE AF-TIMI 48 trial was a randomized, double-blind, double-dummy clinical trial comparing 2 once-daily edoxaban dose regimens with warfarin in 21 105 patients with AF at moderate to high risk of stroke. The CHA 2DS 2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 or ≥75 years, diabetes mellitus, and stroke, transient ischemic attack or thromboembolism –vascular disease, and sex category ) risk score is pragmatic and widely used but has only moderate discrimination. Importance Treatment decisions in atrial fibrillation (AF) are based on clinical assessment of risk.
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