Abstract

Background: It was found that 50% of patients with iliofemoral deep venous thrombosis (DVT) treated by anticoagulant alone and compression stocking developed post thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase venous patency and prevent PTS. The objective of the study was to assess short-term efficacy of additional catheter directed thrombolysis (CDT) compared with standard anticoagulant therapy alone.Methods: Prospective, randomized, controlled study on 50 patients (18–75 years) with acute iliofemoral DVT and symptoms <21 days were randomized to receive additional CDT or standard anticoagulant therapy alone. After 6 months, vein patency and insufficiency (reflux) was assessed using duplex ultrasound by an investigator blinded to previous treatments.Results: Fifty patients were allocated additional CDT (n=25) or ACs alone (n=25). After CDT, grade III (complete) lysis was achieved in 17 (68%) and grade II (50%–90%) lysis in 5 patients (20%). One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 17 (68%) in the CDT group vs. 8 (32%) controls, corresponding to an absolute risk reduction 36% (95% CI, p=0.002). Femoral venous insufficiency was found to be higher among the ACs group 11 patients (44%) vs. 7 patients (28%) in the CDT group.Conclusions: After 6 months, additional CDT increased iliofemoral patency from 32% to 68% and decreased venous insufficiency from 44% to 28%.

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