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

Pascale Notten; Carsten W. K. P. Arnoldussen; Rutger Brans; Andre A. E. A. de Smet; Lidwine W. Tick; Marlene H. W. van de Poel; Otmar R. M. Wikkeling; Louis-Jean Vleming; Ad Koster; Kon-Siong G. Jie; Esther M. G. Jacobs; Harm P. Ebben; Nils Planken; Hugo ten Cate; Cees H. A. Wittens; Arina J. ten Cate-Hoek

doi:10.1055/s-0040-1713171

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

Pascale Notten, Carsten W. K. P. Arnoldussen, Rutger Brans, Andre A. E. A. de Smet, Lidwine W. Tick, Marlene H. W. van de Poel, Otmar R. M. Wikkeling, Louis-Jean Vleming, Ad Koster, Kon-Siong G. Jie, Esther M. G. Jacobs, Harm P. Ebben, Nils Planken, Hugo ten Cate, Cees H. A. Wittens, Arina J. ten Cate-Hoek^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 kappa = 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.

Original language	English
Pages (from-to)	1188-1199
Number of pages	12
Journal	Thrombosis and Haemostasis
Volume	120
Issue number	08
DOIs	https://doi.org/10.1055/s-0040-1713171
Publication status	Published - Aug 2020

Keywords

deep vein thrombosis
postthrombotic syndrome
thrombolysis
thrombolytic agents
vascular patency
quality of life
DEEP-VEIN THROMBOSIS
VENOUS THROMBOSIS
RISK-FACTORS
1ST EPISODE
VALIDATION
DETERMINANTS
TRANSLATION
RECURRENCE
SEVERITY
THERAPY

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10.1055/s-0040-1713171

Cite this

Notten, P., Arnoldussen, C. W. K. P., Brans, R., de Smet, A. A. E. A., Tick, L. W., van de Poel, M. H. W., Wikkeling, O. R. M., Vleming, L.-J., Koster, A., Jie, K.-S. G., Jacobs, E. M. G., Ebben, H. P., Planken, N., ten Cate, H., Wittens, C. H. A., & ten Cate-Hoek, A. J. (2020). Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial. Thrombosis and Haemostasis, 120(08), 1188-1199. https://doi.org/10.1055/s-0040-1713171

@article{a5975a5780bc4464988aac2c8631446e,

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

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 kappa = 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.",

keywords = "deep vein thrombosis, postthrombotic syndrome, thrombolysis, thrombolytic agents, vascular patency, quality of life, DEEP-VEIN THROMBOSIS, VENOUS THROMBOSIS, RISK-FACTORS, 1ST EPISODE, VALIDATION, DETERMINANTS, TRANSLATION, RECURRENCE, SEVERITY, THERAPY",

author = "Pascale Notten and Arnoldussen, {Carsten W. K. P.} and Rutger Brans and {de Smet}, {Andre A. E. A.} and Tick, {Lidwine W.} and {van de Poel}, {Marlene H. W.} and Wikkeling, {Otmar R. M.} and Louis-Jean Vleming and Ad Koster and Jie, {Kon-Siong G.} and Jacobs, {Esther M. G.} and Ebben, {Harm P.} and Nils Planken and {ten Cate}, Hugo and Wittens, {Cees H. A.} and {ten Cate-Hoek}, {Arina J.}",

note = "Funding Information: 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. Publisher Copyright: {\textcopyright} 2020 Georg Thieme Verlag. All rights reserved.",

year = "2020",

month = aug,

doi = "10.1055/s-0040-1713171",

language = "English",

volume = "120",

pages = "1188--1199",

journal = "Thrombosis and Haemostasis",

issn = "0340-6245",

publisher = "Georg Thieme Verlag",

number = "08",

}

Notten, P, Arnoldussen, CWKP, Brans, R, de Smet, AAEA, Tick, LW, van de Poel, MHW, Wikkeling, ORM, Vleming, L-J, Koster, A, Jie, K-SG, Jacobs, EMG, Ebben, HP, Planken, N, ten Cate, H, Wittens, CHA & ten Cate-Hoek, AJ 2020, 'Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial', Thrombosis and Haemostasis, vol. 120, no. 08, pp. 1188-1199. https://doi.org/10.1055/s-0040-1713171

Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial. / Notten, Pascale; Arnoldussen, Carsten W. K. P.; Brans, Rutger et al.
In: Thrombosis and Haemostasis, Vol. 120, No. 08, 08.2020, p. 1188-1199.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome

T2 - A Post Hoc Analysis of the CAVA Trial

AU - Notten, Pascale

AU - Arnoldussen, Carsten W. K. P.

AU - Brans, Rutger

AU - de Smet, Andre A. E. A.

AU - Tick, Lidwine W.

AU - van de Poel, Marlene H. W.

AU - Wikkeling, Otmar R. M.

AU - Vleming, Louis-Jean

AU - Koster, Ad

AU - Jie, Kon-Siong G.

AU - Jacobs, Esther M. G.

AU - Ebben, Harm P.

AU - Planken, Nils

AU - ten Cate, Hugo

AU - Wittens, Cees H. A.

AU - ten Cate-Hoek, Arina J.

N1 - Funding Information: 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. Publisher Copyright: © 2020 Georg Thieme Verlag. All rights reserved.

PY - 2020/8

Y1 - 2020/8

N2 - 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 kappa = 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.

AB - 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 kappa = 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.

KW - deep vein thrombosis

KW - postthrombotic syndrome

KW - thrombolysis

KW - thrombolytic agents

KW - vascular patency

KW - quality of life

KW - DEEP-VEIN THROMBOSIS

KW - VENOUS THROMBOSIS

KW - RISK-FACTORS

KW - 1ST EPISODE

KW - VALIDATION

KW - DETERMINANTS

KW - TRANSLATION

KW - RECURRENCE

KW - SEVERITY

KW - THERAPY

U2 - 10.1055/s-0040-1713171

DO - 10.1055/s-0040-1713171

M3 - Article

C2 - 32604427

SN - 0340-6245

VL - 120

SP - 1188

EP - 1199

JO - Thrombosis and Haemostasis

JF - Thrombosis and Haemostasis

IS - 08

ER -