A randomised controlled trial of extended anticoagulation treatment versus standard treatment for the prevention of recurrent venous thromboembolism (VTE) and post‐thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (the ExACT study)

Abstract

Summary 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, multicentred randomised controlled trial comparing extended versus limited duration anticoagulation following a first unprovoked VTE (proximal deep vein thrombosis or pulmonary embolism). 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. Two‐hundred and eighty‐one 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, adjusted hazard ratio (aHR) 0·20 (95% confidence interval (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: 0·81–11·05, P = 0·10)]. Outcomes of PTS and QoL 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 on anticoagulated patients.

Prevention and Management of the Post-Thrombotic Syndrome

“…The Extended AntiCoagulation Treatment for venous thromboembolism (ExACT) trial evaluated whether extended anticoagulation reduces the risk of PTS and increases quality of life [43]. This trial randomized 281 participants with unprovoked proximal VTE who had already completed 3 months of anticoagulation to either discontinue anticoagulation or continue for a total of 2 years.…”

Patients with high levels of circulating endothelial progenitor cells (EPC) following at least three months of anticoagulation for unprovoked venous thromboembolism (VTE) are at low risk of recurrent VTE—Results from the ExACT randomised controlled trial.

“…As reported in the main trial paper [25], all primary analyses (primary and secondary outcomes) were performed on an intention to treat basis (ITT).…”

“…Blood samples were taken from patients at baseline whilst still on anticoagulation. The main trial findings and point of care d -dimer testing results are published separately [25]. We hypothesised that quantitation of circulating endothelial progenitor cells may be a candidate predictive biomarker of VTE recurrence risk to aid clinical decision making on anticoagulation duration.…”

Profilaxia de tromboembolismo venoso para pacientes hospitalizados

“…6,7 Potencialmente, o correto planejamento estratégico da profilaxia visa a redução da ocorrência de TVP e suas consequências e, secundariamente, a redução no número de dias de internação e dos custos do tratamento hospitalar. 2,5,[8][9][10][11][12][13]…”