Thromb Haemost 2020; 120(08): 1188-1199
DOI: 10.1055/s-0040-1713171
New Technologies, Diagnostic Tools and Drugs

Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial

1   Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
2   Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands
,
Carsten W. K. P. Arnoldussen
3   Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
4   Department of Radiology and Nuclear Medicine, VieCuri Medical Centre, Venlo, The Netherlands
,
Rutger Brans
3   Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
,
André A. E. A. de Smet
5   Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands
,
Lidwine W. Tick
6   Department of Internal Medicine, Maxima Medical Centre, Eindhoven, The Netherlands
,
Marlène H. W. van de Poel
7   Department of Internal Medicine, Laurentius Hospital, Roermond, The Netherlands
,
Otmar R. M. Wikkeling
8   Department of Vascular Surgery, Nij Smellinghe Hospital, Drachten, The Netherlands
,
Louis-Jean Vleming
9   Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands
,
Ad Koster
10   Department of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands
,
Kon-Siong G. Jie
11   Department of Internal Medicine, Zuyderland Medical Centre, Sittard, The Netherlands
,
Esther M. G. Jacobs
12   Department of Internal Medicine, Elkerliek Hospital, Helmond, The Netherlands
,
Harm P. Ebben
13   Department of Vascular Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands
,
Nils Planken
14   Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands
,
Hugo ten Cate
2   Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands
15   Laboratory for Clinical Thrombosis and Hemostasis, Maastricht University, Maastricht, The Netherlands
16   Thrombosis Expertise Centre, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands
,
Cees H. A. Wittens*
1   Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
,
Arina J. ten Cate-Hoek
2   Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands
15   Laboratory for Clinical Thrombosis and Hemostasis, Maastricht University, Maastricht, The Netherlands
16   Thrombosis Expertise Centre, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands
› Author Affiliations
Funding The trial was funded by a grant from ZonMw (The Netherlands Organisation for Health Research and Development, project number 171101001) and BTG-Interventional Medicine. Additional funding was provided by the board of the Maastricht University Medical Centre.
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Abstract

Background The CAVA trial did not show the anticipated risk reduction for postthrombotic syndrome (PTS) after thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT) in patients with acute iliofemoral deep vein thrombosis (IFDVT). Difficulties in achieving an effective degree of recanalization through thrombolysis may have influenced outcomes. We therefore assessed whether successful UACDT (restored patency ≥ 90%) did reduce the development of PTS.

Methods This CAVA trial post hoc analysis compared the proportion of PTS at 1-year follow-up between patients with successful UACDT and patients that received standard treatment only. In addition, clinical impact as well as determinants of successful thrombolysis were explored.

Results UACDT was initiated in 77 (50.7%) patients and considered successful in 41 (53.2%, interrater agreement κ = 0.7, 95% confidence interval 0.47–0.83). PTS developed in 15/41 (36.6%) patients in the successful UACDT group versus 33/75 (44.0%) controls (p = 0.44). In this comparison, successful UACDT was associated with lower Venous Clinical Severity Score (3.50 ± 2.57 vs. 4.82 ± 2.74, p = 0.02) and higher EuroQOL-5D (EQ-5D) scores (40.2 ± 36.4 vs. 23.4 ± 34.4, p = 0.01). Compared with unsuccessful UACDT, successful UACDT was associated with a shorter symptom duration at inclusion (p = 0.05), and higher rates of performed adjunctive procedures (p < 0.001) and stent placement (p < 0.001).

Conclusion Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone. There was, however, a significant reduction in symptom severity and improvement of generic quality of life according to the EQ-5D. Better patient selection and optimization of treatment protocols are needed to assess the full potential of UACDT for the prevention of PTS.

Trial Registration Number ClinicalTrials.gov number, NCT00970619.

* Emeritus professor of venous surgery.




Publication History

Received: 20 February 2020

Accepted: 06 May 2020

Article published online:
30 June 2020

Georg Thieme Verlag KG
Stuttgart · New York