CAVA (Ultrasound-accelerated catheter-directed thrombolysis on preventing post-thrombotic syndrome) trial: Long-term follow-up results

Autor: Louis-Jean Vleming, Ad Koster, Esther M. G. Jacobs, Otmar R. M. Wikkeling, Marlène H. W. van de Poel, Arina J. ten Cate-Hoek, Cees H. A. Wittens, Kon-Siong G. Jie, Hugo ten Cate, Harm P. Ebben, Lidwine W. Tick, Pascale Notten, Michiel Coppens, André A. E. A. de Smet
Přispěvatelé: Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, RS: Carim - B04 Clinical thrombosis and Haemostasis, Vascular Surgery, MUMC+: MA Heelkunde (9), Interne Geneeskunde, MUMC+: HVC Trombosezorg (8), MUMC+: MA Alg Interne Geneeskunde (9), MUMC+: HVC Pieken Trombose (9), Surgery, Internal medicine, ACS - Atherosclerosis & ischemic syndromes
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Time Factors
medicine.medical_treatment
DETERMINANTS
Iliac Vein
030204 cardiovascular system & hematology
DISEASE
Postthrombotic Syndrome
0302 clinical medicine
QUALITY-OF-LIFE
Post-thrombotic syndrome
Vascular Disease
Single-Blind Method
Thrombolytic Therapy
030212 general & internal medicine
DEEP-VEIN THROMBOSIS
Ultrasonography
Original Research
Aged
80 and over
Venous Thrombosis
Ultrasound
Catheter-directed thrombolysis
Thrombolysis
Middle Aged
Iliofemoral deep vein thrombosis
Treatment Outcome
Editorial
Female
NONINVASIVE VENOUS EXAMINATIONS
Cardiology and Cardiovascular Medicine
Adult
medicine.medical_specialty
Catheters
catheter‐directed thrombolysis
Adolescent
Long term follow up
venous thromboembolism
Catheter directed thrombolysis
1ST EPISODE
deep vein thrombosis
VALIDATION
Young Adult
03 medical and health sciences
medicine
Humans
Diseases of the circulatory (Cardiovascular) system
Long-term follow-up
Aged
LEG
post‐thrombotic syndrome
business.industry
Editorials
chronic venous insufficiency
CLINICAL INVESTIGATIONS
Femoral Vein
medicine.disease
Surgery
vein thrombosis
Peripheral Vascular Disease
quality of life
Therapy
Computer-Assisted
RC666-701
long‐term follow‐up
TRANSLATION
business
Follow-Up Studies
Zdroj: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 11 (2021)
Journal of the American Heart Association, 10(11):e018973. Wiley-Blackwell
Notten, P, 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, Coppens, M, ten Cate, H, Wittens, C H A & ten Cate-Hoek, A J 2021, ' CAVA (Ultrasound-accelerated catheter-directed thrombolysis on preventing post-thrombotic syndrome) trial: Long-term follow-up results ', Journal of the American Heart Association, vol. 10, no. 11, e018973 . https://doi.org/10.1161/JAHA.120.018973
Journal of the American Heart Association, 10(11):018973. Wiley
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
ISSN: 2047-9980
DOI: 10.1161/jaha.120.018973
Popis: Background The 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 Results Patients 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. Conclusions The 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. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00970619.
Databáze: OpenAIRE
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