Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thromboembolic infrainguinal disease (DUET): design and rationale

A Marjolein Schrijver,Pieter Hm Van Der Valk,Jean-Paul Pm De Vries,Jacques A Van Oostayen,Rutger J Lely,Bram Fioole,Michel Mpj Reijnen,Arjan Wj Hoksbergen,Dammis Vroegindeweij,Rudolf Pj Tutein Nolthenius,Marc Van Leersum

doi:10.1186/1745-6215-12-20

Abstract

BackgroundThe use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis.Methods/designSixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery.DiscussionThe DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications.Trial registrationCurrent Controlled Trials ISRCTN72676102

Highlights

The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years
Thrombosis of an infrainguinal bypass graft or the native lower leg arteries has been associated with a high rate of limb loss and significant morbidity and mortality [1]
The incidence of these complications might be reduced by a reduction in thrombolytic therapy time

Summary

Introduction

The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, is the occurrence of bleeding complications. Low-intensity US-accelerated thrombolysis has been shown to accelerate enzymatic clot lysis in vitro by loosening fibrin strands and thereby increasing thrombus permeability and exposing more plasminogen receptors for binding, without mechanically disrupting the clot [6,7,8] The safety of this technique has been shown in the treatment of embolic stroke [9] and deep venous thrombosis [10]. No bleeding or other complications occurred [12]

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