CAVA (Ultrasound-Accelerated Catheter-Directed Thrombolysis on Preventing Post-Thrombotic Syndrome) Trial: Long-Term Follow-Up Results.

Content Provider	Europe PMC
Author	Notten, Pascale de Smet, André A. E. A. Tick, Lidwine W. van de Poel, Marlène H. W. Wikkeling, Otmar R. M. Vleming, Louis‐Jean Koster, Ad Jie, Kon‐Siong G. Jacobs, Esther M. G. Ebben, Harm P. Coppens, Michiel ten Cate, Hugo Wittens, Cees H. A. ten Cate‐Hoek, Arina J.
Abstract	BackgroundThe CAVA (Ultrasound‐Accelerated Catheter‐Directed Thrombolysis Versus Anticoagulation for the Prevention of Post‐Thrombotic Syndrome) trial did not show a reduction of post‐thrombotic syndrome (PTS) after additional ultrasound‐accelerated catheter‐directed thrombolysis in patients with acute iliofemoral deep vein thrombosis at 1‐year follow‐up. This prespecified analysis of the CAVA trial aimed to determine the impact of additional thrombolysis on outcomes of PTS at long‐term follow‐up.Methods and ResultsPatients aged 18 to 85 years with a first‐time acute iliofemoral deep vein thrombosis were included and randomly assigned (1:1) to either standard treatment plus ultrasound‐accelerated catheter‐directed thrombolysis or standard treatment alone. The primary outcome was the proportion of PTS (Villalta score ≥5 on 2 occasions ≥3 months apart or venous ulceration) at the final follow‐up visit. Additionally, PTS according to the International Society on Thrombosis and Haemostasis (ISTH) consensus definition was assessed to allow external comparability. Major bleedings were the main safety outcome. At a median follow‐up of 39.0 months (interquartile range, 23.3–63.8), 120 patients (79.8%) participated in the final follow‐up visit: 62 from the intervention group and 58 from the standard treatment group. PTS developed in 19 (30.6%) versus 26 (44.8%) patients, respectively (odds ratio [OR], 0.54; 95% CI, 0.26 to 1.15 [P=0.11]), with an absolute difference between groups of −14.2% (95% CI, −32.0% to 4.8%). Using the ISTH consensus definition, a significant reduction in PTS was observed (29 [46.8%] versus 40 [69.0%]) (OR, 0.40; 95% CI, 0.19–0.84 [P=0.01]) with an absolute difference between groups of −22.2% (95% CI, −39.8% to −2.8%). No new major bleedings occurred following the 12‐month follow‐up.ConclusionsThe impact of additional ultrasound‐accelerated catheter‐directed thrombolysis on the prevention of PTS was found to increase with time. Although this study was limited by its sample size, the overall findings indicate a reduction of mild PTS without impact on quality of life.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT00970619.
Page Count	11
Journal	Journal of the American Heart Association
Volume Number	10
PubMed Central reference number	PMC8483549
Issue Number	11
PubMed reference number	34032127
e-ISSN	20479980
DOI	10.1161/jaha.120.018973
Language	English
Publisher	John Wiley and Sons Inc.
Publisher Date	2021-05-25
Publisher Place	Hoboken
Access Restriction	Open
Rights License	This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. © 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
Subject Keyword	catheter‐directed thrombolysis Iliofemoral deep vein thrombosis long‐term follow‐up post‐thrombotic syndrome quality of life
Content Type	Text
Resource Type	Article
Subject	Cardiology and Cardiovascular Medicine