J Thromb Haemost: Analysis of devasalban efficacy in patients with antiphospholipid syndrome

The Devasalban Treatment (TRAPS) trial in patients with antiphospholipid syndrome is a prospective randomized open non-inferior study conducted at 14 centres in Italy.
researchers compared devassalban with huafarin to prevent thromboembolism events, haemorrhage and vascular death in high-risk triple-positive antiphospholipid syndrome patients.
recently, a study published in Journal of Thrombosis and Haemostasis, an authoritative journal of thrombosis and clotting diseases, looked at events within two years of the end of the study.
28 January 2018, the Trial and Safety Commission suspended the trial early due to a number of adverse events in the Devassa team.
patients who were randomly grouped to devasalban were transferred to huafarin therapy.
all 14 participating centres were required to follow up patients on clinical events.
report describes the rate of incidents between 28 January 2018 and 28 January 2020.
115 follow-up data were available in 120 randomly grouped patients.
found that 2 out of every 6 (33.3%) of patients who still used DOAC had an event, while 6 out of 109 patients who took huafalin (5.7%) had an event (HR of 6.9; 95% CI of 1.4-34.5, p-0.018).
2 patients who took DOAC (1 patient taking dabiga group and 1 patient taking devasaban) had a thrombosis event, while 6 patients who took Huada had a compound outcome and 3 cases had a thrombosis event (HR for thrombosis 13.3; 95CI was 2.2-79.9, p=0.005).
, these data further support the application of wahfalin in APS high-risk patients.