A Prospective Randomized Trial of Catheter-Directed Thrombolysis With Additional Balloon Dilatation for Iliofemoral Deep Venous Thrombosis: A Single-Center Experience

Catheter-directed thrombolysis (CDT) is effective for acute iliofemoral deep venous thrombosis (DVT), but CDT remains partially effective for subacute DVT. The aim of this study was to conduct a prospective randomized controlled single-centre clinical trial to compare CDT alone with CDT with additional balloon dilatation for the treatment of iliofemoral DVT. The trial was performed between February 2007 and January 2011. Iliofemoral DVT patients lacking effective therapy before enrollment were randomly assigned either to CDT (control group) or to CDT with additional balloon dilatation (intervention group). Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL), Severity of Venous Lower Limb Symptoms (VEINES-Sym), 36-Item Short-Form Health Survey (SF-36), and Villalta scores were obtained at scheduled follow-up. Seven hundred twenty-two patients were screened, and 386 eligible patients were randomized. No significant difference for mean total Villalta score was observed between the intervention group (4.20 +/- A 3.05) and the control group (4.89 +/- A 3.45). However, post hoc analysis of the scores in subacute patients showed significant differences between the intervention group and the control group from 1 month (6.79 +/- A 4.23, 8.28 +/- A 5.03, P = 0.02) to 24 months (4.21 +/- A 3.08, 5.67 +/- A 3.71, P = 0.006). A significant difference was also observed in subacute patients at the end of follow-up for VEINES-QOL/Sym (52.87 +/- A 6.52, 50.31 +/- A 6.07, P = 0.009; 51.87 +/- A 6.37, 49.72 +/- A 5.96, P = 0.02) and SF-36 PCS/MCS (45.02 +/- A 12.07, 41.13 +/- A 11.68, P = 0.03; 53.26 +/- A 11.43, 49.50 +/- A 11.06, P = 0.03). Subacute iliofemoral DVT patients lacking effective therapy during acute phase, might receive more benefits from CDT with additional balloon dilatation. However, CDT alone is highly effective for acute patients.