Ultrasonography-guided oral anticoagulant therapy reduced recurrent venous thromboembolism

Randomized controlled trial (Ultrasound Findings to Adjust the Duration of Anticoagulation in Patients With Deep Vein Thrombosis [AESOPUS] study). ClinicalTrials.gov NCT00380120.

{Concealed}*.†

Blinded (outcome assessors).†

33 months.

9 university or hospital centers in Italy.

538 patients (median age 65 y, 50% men) ≥ 18 years of age who had a first symptomatic proximal DVT and had completed 3 months of OAT. Exclusion criteria included previous VTE, cancer, immobilization due to irreversible disease, indefinite need for anticoagulation due to atrial fibrillation or valve replacement, deficiencies of natural anticoagulants or lupus-like anticoagulants, major bleeding during the first 3 months of OAT, pregnancy, or life expectancy < 3 months.

Flexible-duration OAT, with duration based on residual thrombi on ultrasonography at randomization, 3 and 9 months in all patients, and at 15 and 21 months in patients with unprovoked DVT (n = 270) or fixed-duration OAT (n = 268), with OAT stopped at randomization in patients with secondary DVT or continued for 3 additional months in those with unprovoked DVT.

Symptomatic recurrent VTE and death during follow-up and major bleeding during and ≤ 1 month after anticoagulation.

99% (intention-to-treat analysis).

The main results are in the Table.

Flexible-duration, ultrasonography-guided oral anticoagulant therapy reduced recurrent venous thromboembolism more than fixed-duration therapy.