Dutch randomized trial comparing standard catheter-directed thrombolysis and ultrasound-accelerated thrombolysis for arterial thromboembolic infrainguinal disease (DUET).

To report the results of the Dutch randomized trial comparing standard catheter-directed and ultrasound-accelerated thrombolysis (UST) for the treatment of arterial thromboembolic occlusions. The DUET study ( controlled-trials.com ; identifier ISRCTN72676102) was designed to assess whether UST can reduce therapy time significantly compared with standard thrombolysis (ST). Sixty patients (44 men; mean age 64 years) with recently (7-49 days) thrombosed infrainguinal native arteries or bypass grafts causing acute limb ischemia (Rutherford category I or IIa) were randomized to ST (n = 32) or UST (n = 28). The primary outcome was the duration of thrombolysis needed for uninterrupted flow (> 95% thrombus lysis), with outflow through at least 1 below-the-knee artery. Continuous data are presented as means ± standard deviations. Thrombolysis was significantly faster in the UST group (17.7 ± 2.0 hours) than in the ST group (29.5 ± 3.2 hours, p = 0.009) and required significantly fewer units of urokinase (2.8 ± 1.6 × 10(6) IU in the ST group vs. 1.8 ± 1.0 × 10(6) IU in the UST group, p = 0.01) for uninterrupted flow. Technical success was achieved in 27 (84%) patients in the ST group vs. 21 (75%) patients in the UST group (p = 0.52). The combined 30-day death and severe adverse event rate was 19% in the ST group and 29% in the UST group (p = 0.54). The 30-day patency rate was 82% in the ST group as compared with 71% in the UST group (p = 0.35). Thrombolysis time was significantly reduced by UST as compared with ST in patients with recently thrombosed infrainguinal native arteries or bypass grafts.