Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial

RCT (n=328) found age/weight adjusted dabigatran non-inferior to standard of care (LMWH/unfractionated heparin/vit K antagonists/fondaparinux) for the composite efficacy endpoint of thrombus resolution, & no recurrent VTE or VTE-death: 42%vs 46%; p<0.0001)

SPS commentary:

Bleeding events were similar to standard of care (22% vs 24%) as were major bleeding events (2% vs 2%).

The Lancet Haematology