Development of a novel composite stroke and bleeding risk score in patients with atrial fibrillation: The AMADEUS study.
Chest. 2013 Sep 5;
Authors: Lip GY, Lane DA, Buller H, Apostolakis S
ABSTRACT BACKGROUND The aim of the present analysis was to identify independent predictors of the overall clinical outcome of patients with atrial fibrillation (AF), including both stroke/thromboembolism and/or major bleeding. Given the overlap between stroke and bleeding risk factors, a composite risk stratification score for stroke/thromboembolism or bleeding could potentially be developed. METHODS We used data from the vitamin K antagonist (VKA) arm (n=2293; 65% men, mean age 70±9) of the AMADEUS trial, which was a multicentre, randomised, open-label non-inferiority study that compared fixed-dose idraparinux with VKA in AF patients. We defined two composite endpoints: Endpoint 1 was the sum of stroke/thromboembolism or major bleeding. Endpoint 2 was defined as the sum of stroke, systemic or venous embolism, myocardial infarction, cardiovascular death or major bleeding. RESULTS The independent predictors for composite endpoint 1 were age (p=0.014), previous stroke/TIA (p=0.049), aspirin use (p=0.002) and time in therapeutic range (TTR) (p=0.007). For composite endpoint 2, similar predictors were evident, plus LV dysfunction (p=0.011). Based on the regression models, two novel composite risk prediction scores were developed and externally validated in a 'real world' cohort of 441 anticoagulated outpatients with AF. Both composite scores 1 and 2 demonstrated numerically highest discriminatory performance (area under the curve[AUC] 0.728; 95%CI: 0.659-0.798 and AUC 0.707; 95%CI: 0.655-0.758, for endpoints 1 and 2 respectively), and positive net reclassification when compared to currently used risk models (CHADS2, CHA2DS2VASc, HAS-BLED), but the differences were not statistically significant. CONCLUSION We have developed and validated 2 novel composite scores for stroke/thromboembolism/ bleeding that offer good discriminatory and predictive performance. However, these composite risk scores did not perform better than the easier and more practical 'traditional' stroke and bleeding risk scores that are currently in use, which allow greater practically and more personalised balancing of risks.
PMID: 24009027 [PubMed - as supplied by publisher]