Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute ilio-femoral deep vein thrombosis: one-year follow-up data of a randomized-controlled trial.

Engelberger, Rolf P.; Stuck, Anna; Spirk, David; Willenberg, Torsten; Haine, Axel; Périard, Daniel; Baumgartner, Iris; Kucher, Nils (2017). Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute ilio-femoral deep vein thrombosis: one-year follow-up data of a randomized-controlled trial. Journal of thrombosis and haemostasis, 15(7), pp. 1351-1360. Wiley-Blackwell 10.1111/jth.13709

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BACKGROUND In patients with acute ilio-femoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the post-thrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. PATIENTS/METHODS In this randomized-controlled trial, 48 patients (mean age 50±21 years, 52% women) with acute IFDVT were randomized to conventional CDT (n=24) or ultrasound-assisted CDT (USAT; n=24). In both groups, a fixed-dose thrombolysis regimen (20mg r-tPA over 15 hours) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease specific quality of live (QOL; CIVIQ-20), and duplex-sonographic outcomes were assessed. RESULTS Among the 45 surviving patients, 40 (89%;95%CI 76-96%) patients were free from PTS (defined as Villalta score <5 points, 83%;95%CI 61-95% in the USAT and 96%;95%CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3±2.9 versus 1.7±1.6, and a mean total rVCSS of 3.0±3.5 versus 2.7±2.9 in the USAT and the CDT groups, respectively. Both groups had good disease specific QOL with a CIVIQ-20 score of 29.4±11.8 versus 26.1±7.8, respectively. Primary (100% vs 92%) and secondary (100% vs 96%) ilio-femoral patency rates, and presence of femoro-popliteal venous reflux (39% versus 33%) were similar in both groups. CONCLUSION The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. This article is protected by copyright. All rights reserved.

Item Type:

Journal Article (Original Article)

Division/Institute:

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

UniBE Contributor:

Engelberger, Rolf Peter; Stuck, Anna; Spirk, David; Willenberg, Torsten Andreas; Haine, Axel; Baumgartner, Iris and Kucher, Nils

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1538-7836

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Catherine Gut

Date Deposited:

17 Jul 2017 14:27

Last Modified:

13 Dec 2019 10:57

Publisher DOI:

10.1111/jth.13709

PubMed ID:

28440041

Uncontrolled Keywords:

postthrombotic syndrome; thrombolytic therapy; thrombosis; ultrasonography; veins

BORIS DOI:

10.7892/boris.99572

URI:

https://boris.unibe.ch/id/eprint/99572

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