title: Dutch randomized trial comparing standard catheter-directed thrombolysis and ultrasound-accelerated thrombolysis for arterial thromboembolic infrainguinal disease (DUET).
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  Thrombolysis time was significantly reduced by UST as compared with ST in patients with recently thrombosed infrainguinal native arteries or bypass grafts.
authors.affiliation: Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: A Marjolein
authors.initials: AM
authors.lastname: Schrijver
authors.affiliation: Department of Interventional Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: van Leersum
authors.affiliation: Maasstad Hospital, Rotterdam, The Netherlands.
authors.forename: Bram
authors.initials: B
authors.lastname: Fioole
authors.affiliation: Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: Michel M P J
authors.initials: MM
authors.lastname: Reijnen
authors.affiliation: Free University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Arjan W J
authors.initials: AW
authors.lastname: Hoksbergen
authors.affiliation: Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Anco C
authors.initials: AC
authors.lastname: Vahl
authors.affiliation: Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, The Netherlands j.vries@antoniusziekenhuis.nl.
authors.forename: Jean-Paul P M
authors.initials: JP
authors.lastname: de Vries
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000401:mortality / Q000628:therapy*; D066254:Axillofemoral Bypass Grafting; D002406:Catheterization, Peripheral; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006784:Hospitals, Teaching; D006801:Humans; D007511:Ischemia; D053208:Kaplan-Meier Estimate; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D061185:Mechanical Thrombolysis / Q000009:adverse effects / Q000401:mortality; D008875:Middle Aged; D009426:Netherlands; D011446:Prospective Studies; D012307:Risk Factors; D013923:Thromboembolism / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D015912:Thrombolytic Therapy / Q000401:mortality; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods
chemical_list: D005343:Fibrinolytic Agents
keywords: bleeding; complications; occlusion; peripheral artery occlusive disease; thrombolysis; thrombolytic therapy; thrombosis; ultrasound; urokinase