Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thromboembolic infrainguinal disease (DUET): design and rationale.
BACKGROUND
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, 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
Sixty 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.


CONCLUSIONS
The 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.


BACKGROUND
Current Controlled Trials ISRCTN72676102.
Department of Surgery, St, Antonius Hospital Nieuwegein, The Netherlands.
A Marjolein
AM
Schrijver
Michel M P J
MM
Reijnen
Jacques A
JA
van Oostayen
Rudolf P J Tutein
RP
Nolthenius
Pieter H M
PH
van der Valk
Arjan W J
AW
Hoksbergen
Rutger J
RJ
Lely
Bram
B
Fioole
Dammis
D
Vroegindeweij
Marc
M
van Leersum
Jean-Paul P M
JP
de Vries
D000328:Adult; D002406:Catheterization, Peripheral / Q000009:adverse effects; D003131:Combined Modality Therapy; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006784:Hospitals, Teaching; D006801:Humans; D007261:Infusions, Intra-Arterial; D007511:Ischemia / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D009426:Netherlands; D012107:Research Design; D013923:Thromboembolism / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D015912:Thrombolytic Therapy / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects; D014654:Vascular Patency
D005343:Fibrinolytic Agents
J Vasc Surg. 1992 Feb;15(2):385-91; discussion 392-3
1735899
J Vasc Surg. 2000 Jan;31(1 Pt 2):S1-S296
10666287
N Engl J Med. 1998 Apr 16;338(16):1105-11
9545358
Stroke. 2010 Feb;41(2):280-7
20044531
J Vasc Surg. 2010 Aug;52(2):512-5
20434297
J Vasc Interv Radiol. 2008 Apr;19(4):521-8
18375296
J Vasc Surg. 1989 Mar;9(3):426-31
2921792
J Vasc Surg. 1997 Sep;26(3):517-38
9308598
J Endovasc Ther. 2007 Apr;14(2):251-6
17484537
Thromb Res. 2006;117(6):713-20
15993473
Blood. 1998 Mar 15;91(6):2019-25
9490686
J Endovasc Ther. 2007 Aug;14(4):438-43
17696616
Thromb Haemost. 1997 Sep;78(3):1063-8
9308755
Cochrane Database Syst Rev. 2013 Jun 06;(6):CD002784
23744596
J Vasc Surg. 1988 Feb;7(2):347-55
3123719