BACKGROUND: Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post-thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS. OBJECTIVES: To assess short-term efficacy of additional catheter-directed thrombolysis (CDT) compared with standard treatment alone. PATIENTS AND METHODS: Open, multicenter, randomized, controlled trial. Patients (18-75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air-plethysmography assessed by an investigator blinded to previous treatment. RESULTS:One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%-90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%-46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%-38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups. CONCLUSIONS: After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long-term follow-up of this study will document whether patency is related to improved functional outcome.
RCT Entities:
BACKGROUND: Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post-thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS. OBJECTIVES: To assess short-term efficacy of additional catheter-directed thrombolysis (CDT) compared with standard treatment alone. PATIENTS AND METHODS: Open, multicenter, randomized, controlled trial. Patients (18-75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air-plethysmography assessed by an investigator blinded to previous treatment. RESULTS: One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%-90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%-46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%-38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups. CONCLUSIONS: After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long-term follow-up of this study will document whether patency is related to improved functional outcome.
Authors: Clive Kearon; Elie A Akl; Anthony J Comerota; Paolo Prandoni; Henri Bounameaux; Samuel Z Goldhaber; Michael E Nelson; Philip S Wells; Michael K Gould; Francesco Dentali; Mark Crowther; Susan R Kahn Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: Michael B Streiff; Paula L Bockenstedt; Spero R Cataland; Carolyn Chesney; Charles Eby; John Fanikos; Patrick F Fogarty; Shuwei Gao; Julio Garcia-Aguilar; Samuel Z Goldhaber; Hani Hassoun; Paul Hendrie; Bjorn Holmstrom; Kimberly A Jones; Nicole Kuderer; Jason T Lee; Michael M Millenson; Anne T Neff; Thomas L Ortel; Judy L Smith; Gary C Yee; Anaadriana Zakarija Journal: J Natl Compr Canc Netw Date: 2011-07-01 Impact factor: 11.908