PURPOSE: To present midterm results from a randomized study comparing the safety and efficacy of percutaneous endovenous intervention (PEVI) + anticoagulation vs. anticoagulation alone in the reduction of venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) in acute symptomatic proximal deep venous thrombosis (DVT). METHODS: The TORPEDO trial was a randomized study to demonstrate superiority of PEVI in the reduction of the VTE and PTS at 6 months; in that trial, 183 patients (103 men; mean age 61 ± 11 years) with symptomatic proximal DVT were randomized to receive PEVI + anticoagulation (n = 91) or anticoagulation alone (n = 92). PEVI consisted of one or more of a combination of thrombectomy, balloon venoplasty, stenting, and/or local low-dose thrombolytic therapy. RESULTS: At 6 months, recurrent VTE developed in 2.3% of the PEVI + anticoagulation group vs. 14.8% in the anticoagulation only group (p = 0.003); PTS developed in 3.4% vs. 27.2% (p<0.001), respectively. At a mean follow-up of 30 ± 5 months (range 12-41), 88 patients in the PEVI + anticoagulationgroup and 81 patients in the anticoagulation only group reached target follow-up. Recurrent VTE developed in 4 (4.5%) of the 88 PEVI + anticoagulation patients vs. 13 (16%) of the 81 patients receiving anticoagulation only (p = 0.02). PTS developed in 6 (6.8%) of the PEVI + anticoagulation group vs. 24 (29.6%) of the anticoagulation only group (p<0.001). CONCLUSION: In patients with proximal DVT, PEVI is superior to anticoagulation alone in the reduction of VTE and PTS. This benefit, which appears early in the course of treatment, extends to >2.5 years.
RCT Entities:
PURPOSE: To present midterm results from a randomized study comparing the safety and efficacy of percutaneous endovenous intervention (PEVI) + anticoagulation vs. anticoagulation alone in the reduction of venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) in acute symptomatic proximal deep venous thrombosis (DVT). METHODS: The TORPEDO trial was a randomized study to demonstrate superiority of PEVI in the reduction of the VTE and PTS at 6 months; in that trial, 183 patients (103 men; mean age 61 ± 11 years) with symptomatic proximal DVT were randomized to receive PEVI + anticoagulation (n = 91) or anticoagulation alone (n = 92). PEVI consisted of one or more of a combination of thrombectomy, balloon venoplasty, stenting, and/or local low-dose thrombolytic therapy. RESULTS: At 6 months, recurrent VTE developed in 2.3% of the PEVI + anticoagulation group vs. 14.8% in the anticoagulation only group (p = 0.003); PTS developed in 3.4% vs. 27.2% (p<0.001), respectively. At a mean follow-up of 30 ± 5 months (range 12-41), 88 patients in the PEVI + anticoagulation group and 81 patients in the anticoagulation only group reached target follow-up. Recurrent VTE developed in 4 (4.5%) of the 88 PEVI + anticoagulation patients vs. 13 (16%) of the 81 patients receiving anticoagulation only (p = 0.02). PTS developed in 6 (6.8%) of the PEVI + anticoagulation group vs. 24 (29.6%) of the anticoagulation only group (p<0.001). CONCLUSION: In patients with proximal DVT, PEVI is superior to anticoagulation alone in the reduction of VTE and PTS. This benefit, which appears early in the course of treatment, extends to >2.5 years.