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

A. Marjolein Schrijver, Marc Van Leersum, Bram Fioole, Michel M.P.J. Reijnen, Arjan W.J. Hoksbergen, Anco C. Vahl, Jean Paul P.M. De Vries*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

26 Citations (Scopus)

Abstract

Purpose: To report the results of the Dutch randomized trial comparing standard catheter-directed and ultrasoundaccelerated 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±1.6×106 IU in the ST group vs. 1.8±1.0×106 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.

Original languageEnglish
Pages (from-to)87-95
Number of pages9
JournalJournal of Endovascular Therapy
Volume22
Issue number1
DOIs
Publication statusPublished - 1 Feb 2015
Externally publishedYes

Keywords

  • Bleeding
  • Complications
  • Occlusion
  • Peripheral artery occlusive disease
  • Thrombolysis
  • Thrombolytic therapy
  • Thrombosis
  • Ultrasound
  • Urokinase

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