Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis

Engelberger, Rolf Peter; Spirk, David; Willenberg, Torsten Andreas; Alatri, Adriano; Do, Dai-Do; Baumgartner, Iris; Kucher, Nils (2015). Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis. Circulation: Cardiovascular interventions, 8(1) Lippincott Williams & Wilkins 10.1161/CIRCINTERVENTIONS.114.002027

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BACKGROUND For patients with acute iliofemoral deep vein thrombosis, it remains unclear whether the addition of intravascular high-frequency, low-power ultrasound energy facilitates the resolution of thrombosis during catheter-directed thrombolysis. METHODS AND RESULTS In a controlled clinical trial, 48 patients (mean age 50±21 years, 52% women) with acute iliofemoral deep vein thrombosis were randomized to receive ultrasound-assisted catheter-directed thrombolysis (N=24) or conventional catheter-directed thrombolysis (N=24). Thrombolysis regimen (20 mg r-tPA over 15 hours) was identical in all patients. The primary efficacy end point was the percentage of thrombus load reduction from baseline to 15 hours according to the length-adjusted thrombus score, obtained from standardized venograms and evaluated by a core laboratory blinded to group assignment. The percentage of thrombus load reduction was 55%±27% in the ultrasound-assisted catheter-directed thrombolysis group and 54%±27% in the conventional catheter-directed thrombolysis group (P=0.91). Adjunctive angioplasty and stenting was performed in 19 (80%) patients and in 20 (83%) patients, respectively (P>0.99). Treatment-related complications occurred in 3 (12%) and 2 (8%) patients, respectively (P>0.99). At 3-month follow-up, primary venous patency was 100% in the ultrasound-assisted catheter-directed thrombolysis group and 96% in the conventional catheter-directed thrombolysis group (P=0.33), and there was no difference in the severity of the post-thrombotic syndrome (mean Villalta score: 3.0±3.9 [range 0-15] versus 1.9±1.9 [range 0-7]; P=0.21), respectively. CONCLUSIONS In this randomized controlled clinical trial of patients with acute iliofemoral deep vein thrombosis treated with a fixed-dose catheter thrombolysis regimen, the addition of intravascular ultrasound did not facilitate thrombus resolution. CLINICAL TRIAL REGISTRATION URL http://www.clinicaltrials.gov. Unique identifier: NCT01482273.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Pharmacology
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Engelberger, Rolf Peter; Spirk, David; Willenberg, Torsten Andreas; Do, Dai-Do; Baumgartner, Iris and Kucher, Nils

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1941-7632

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Catherine Gut

Date Deposited:

03 Jul 2015 11:30

Last Modified:

16 Jun 2016 10:22

Publisher DOI:

10.1161/CIRCINTERVENTIONS.114.002027

PubMed ID:

25593121

Uncontrolled Keywords:

catheter; stent; thrombolysis; thrombosis; vein

BORIS DOI:

10.7892/boris.63358

URI:

https://boris.unibe.ch/id/eprint/63358

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