D-dimer and risk of thromboembolic and bleeding events in patients with atrial fibrillation - observations from the ARISTOTLE trial.
J Thromb Haemost. 2014 Jun 18;
Authors: Christersson C, Wallentin L, Andersson U, Alexander JH, Ansell J, De Caterina R, Gersh BJ, Granger CB, Hanna M, Horowitz JD, Huber K, Husted S, Hylek EM, Lopes RD, Siegbahn A
BACKGROUND: D-dimer is related to adverse outcome in arterial and venous thromboembolic diseases.
OBJECTIVES: To evaluate the predictive value of D-dimer for stroke, other cardiovascular event and bleedings, in patients with atrial fibrillation (AF) treated with oral anticoagulation with apixaban or warfarin; and to evaluate the relationship between the D-dimer levels at baseline and the treatment effect of apixaban versus warfarin.
METHODS: In the ARISTOTLE trial 18 201 patients with AF were randomized to apixaban or warfarin. D-dimer was analyzed in 14 878 patients at randomization. The cohort was separated into two groups; not on vitamin K antagonist (VKA) and on VKA treatment at randomization.
RESULTS: Higher D-dimer levels were associated with increased frequency of stroke/systemic embolism HR (Q4 vs Q1) 1.72(95%CI,1.14-2.59), p=0.003, death, HR (Q4 vs Q1) 4.04(95%CI,3.06-5.33), and major bleeding HR (Q4 vs Q1) 2.47(95%CI,1.77-3.45), p<0.0001 in the no VKA group. Similar results were found in the on VKA group. Adding D-dimer to the CHADS2 score improved C-index from 0.646 to 0.655 for stroke/systemic embolism, from 0.598 to 0.662, for death in the no VKA group. D-dimer improved HAS-BLED score for prediction of major bleeds with an increase of C-index from 0.610 to 0.641. There were no significant interactions between efficacy and safety of study treatment and D-dimer level.
CONCLUSION: In anticoagulated patients with AF the level of D-dimer is related to the risk of stroke, death and bleeding and adds to the predictive value of clinical risk scores. The benefits of apixaban were consistent regardless of the baseline D-dimer level. This article is protected by copyright. All rights reserved.
PMID: 24942912 [PubMed - as supplied by publisher]