TY - JOUR
T1 - A Randomised Controlled Trial of Extended Anticoagulation Treatment Versus Standard Treatment for the Prevention of Recurrent VTE and Post-thrombotic Syndrome in Patients Being Treated for a First Episode of Unprovoked VTE (The ExACT Study)
AU - Bradbury, Charlotte A
AU - Fletcher, Kate
AU - Sun, Yongzhong
AU - Heneghan, Carl
AU - Gardiner, Chris
AU - Roalfe, Andrea K
AU - Hardy, Pollyanna
AU - Mccahon, Deborah
AU - Heritage, Gail
AU - Shackleford, Helen
AU - Hobbs, Richard
AU - Fitzmaurice, David A
PY - 2019/11/12
Y1 - 2019/11/12
N2 - Venous thromboembolism (VTE) is prevalent and impactful, with a risk of death, morbidity and recurrence. Post thrombotic syndrome (PTS) is a common consequence and associated with impaired quality of life (QoL).
The ExACT study was a non-blinded, prospective, multi-centred RCT comparing extended versus limited duration anticoagulation following a first unprovoked VTE (Proximal DVT or PE). Adults were eligible if they had completed ≥3 months anticoagulation (remaining anticoagulated). The primary outcome was time to first recurrent VTE from randomisation. The secondary outcomes included PTS severity, bleeding, QoL and D-dimers.
281 patients were recruited, randomised and followed up for 24 months (mean age 63, Male:Female 2:1). There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation (2.75 vs 13.54 events/100 patient years, aHR 0.20(95%CI:0.09 to 0.46, p<0.001)) with a non-significant increase in major bleeding (3.54 vs 1.18 events/100 patient years, aHR 2.99(95%CI:0.81 to 11.05,p=0.10)). PTS and QoL outcomes were no different between groups. D-dimer results (on anticoagulation) did not predict VTE recurrence.
In conclusion, extended anticoagulation reduced VTE recurrence but did not reduce PTS or improve QoL and was associated with a non-significant increase in bleeding. Results also suggest very limited clinical utility of D-dimer testing using a standard cut off on anticoagulated patients.
AB - Venous thromboembolism (VTE) is prevalent and impactful, with a risk of death, morbidity and recurrence. Post thrombotic syndrome (PTS) is a common consequence and associated with impaired quality of life (QoL).
The ExACT study was a non-blinded, prospective, multi-centred RCT comparing extended versus limited duration anticoagulation following a first unprovoked VTE (Proximal DVT or PE). Adults were eligible if they had completed ≥3 months anticoagulation (remaining anticoagulated). The primary outcome was time to first recurrent VTE from randomisation. The secondary outcomes included PTS severity, bleeding, QoL and D-dimers.
281 patients were recruited, randomised and followed up for 24 months (mean age 63, Male:Female 2:1). There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation (2.75 vs 13.54 events/100 patient years, aHR 0.20(95%CI:0.09 to 0.46, p<0.001)) with a non-significant increase in major bleeding (3.54 vs 1.18 events/100 patient years, aHR 2.99(95%CI:0.81 to 11.05,p=0.10)). PTS and QoL outcomes were no different between groups. D-dimer results (on anticoagulation) did not predict VTE recurrence.
In conclusion, extended anticoagulation reduced VTE recurrence but did not reduce PTS or improve QoL and was associated with a non-significant increase in bleeding. Results also suggest very limited clinical utility of D-dimer testing using a standard cut off on anticoagulated patients.
KW - thrombosis (venous)
KW - anticoagulation
KW - warfarin
KW - post‐thrombotic syndrome
KW - D‐dimer
U2 - 10.1111/bjh.16275
DO - 10.1111/bjh.16275
M3 - Article (Academic Journal)
C2 - 31713863
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
ER -