A Marjolein Schrijver1, Marc van Leersum2, Bram Fioole3, Michel M P J Reijnen4, Arjan W J Hoksbergen5, Anco C Vahl6, Jean-Paul P M de Vries7. 1. Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, The Netherlands. 2. Department of Interventional Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands. 3. Maasstad Hospital, Rotterdam, The Netherlands. 4. Rijnstate Hospital, Arnhem, The Netherlands. 5. Free University Medical Centre, Amsterdam, The Netherlands. 6. Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 7. Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, The Netherlands j.vries@antoniusziekenhuis.nl.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: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). CONCLUSION:Thrombolysis time was significantly reduced by UST as compared with ST in patients with recently thrombosed infrainguinal native arteries or bypass grafts.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Thrombolysis time was significantly reduced by UST as compared with ST in patients with recently thrombosed infrainguinal native arteries or bypass grafts.
Authors: Nathan L Liang; Efthymios D Avgerinos; Luke K Marone; Michael J Singh; Michel S Makaroun; Rabih A Chaer Journal: Vasc Endovascular Surg Date: 2016-08 Impact factor: 1.089
Authors: Maria Teresa B Abola; Jonathan Golledge; Tetsuro Miyata; Seung-Woon Rha; Bryan P Yan; Timothy C Dy; Marie Simonette V Ganzon; Pankaj Kumar Handa; Salim Harris; Jiang Zhisheng; Ramakrishna Pinjala; Peter Ashley Robless; Hiroyoshi Yokoi; Elaine B Alajar; April Ann Bermudez-Delos Santos; Elmer Jasper B Llanes; Gay Marjorie Obrado-Nabablit; Noemi S Pestaño; Felix Eduardo Punzalan; Bernadette Tumanan-Mendoza Journal: J Atheroscler Thromb Date: 2020-07-04 Impact factor: 4.928