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

Thrombosis and Haemostasis - Tập 120 Số 08 - Trang 1188-1199 - 2020
Pascale Notten1,2, Carsten W. K. P. Arnoldussen3,4, Rutger Brans3, A.A.E.A. de Smet5, Lidwine W. Tick6, Marlène H. W. van de Poel7, O.R. Wikkeling8, Louis‐Jean Vleming9, Ad Koster10, Kon‐Siong G. Jie11, Esther Jacobs12, Harm P. Ebben13, R. Nils Planken14, Hugo Ten Cate1,15,16, Cees H.A. Wittens2, Arina J. ten Cate‐Hoek1,15,16
1Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands
2Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
3Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands
4Department of Radiology and Nuclear Medicine, VieCuri Medical Centre, Venlo, The Netherlands
5Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands
6Department of Internal Medicine, Maxima Medical Centre, Eindhoven, The Netherlands
7Department of Internal Medicine, Laurentius Hospital, Roermond, the Netherlands
8Department of Vascular Surgery, Nij Smellinghe Hospital, Drachten, The Netherlands
9Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands
10Department of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands
11Department of Internal Medicine, Zuyderland Medical Centre, Sittard, The Netherlands
12Department of Internal Medicine, Elkerliek hospital, Helmond, The Netherlands
13Department of Vascular Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands
14Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands
15Laboratory for Clinical Thrombosis and Hemostasis, Maastricht University, Maastricht, The Netherlands
16Thrombosis Expertise Centre, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands

Tóm tắt

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.

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Tài liệu tham khảo

P Prandoni, 2015, The impact of residual thrombosis on the long-term outcome of patients with deep venous thrombosis treated with conventional anticoagulation, Semin Thromb Hemost, 41, 133, 10.1055/s-0035-1544161

S R Kahn, 2008, Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis, Ann Intern Med, 149, 698, 10.7326/0003-4819-149-10-200811180-00004

S Schulman, 2006, Post-thrombotic syndrome, recurrence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months, J Thromb Haemost, 4, 734, 10.1111/j.1538-7836.2006.01795.x

T Baglin, 2010, Does the clinical presentation and extent of venous thrombosis predict likelihood and type of recurrence? A patient-level meta-analysis, J Thromb Haemost, 8, 2436, 10.1111/j.1538-7836.2010.04022.x

M Stain, 2005, The post-thrombotic syndrome: risk factors and impact on the course of thrombotic disease, J Thromb Haemost, 3, 2671, 10.1111/j.1538-7836.2005.01648.x

L W Tick, 2010, Predictors of the post-thrombotic syndrome with non-invasive venous examinations in patients 6 weeks after a first episode of deep vein thrombosis, J Thromb Haemost, 8, 2685, 10.1111/j.1538-7836.2010.04065.x

L W Tick, 2008, Risk factors for post-thrombotic syndrome in patients with a first deep venous thrombosis, J Thromb Haemost, 6, 2075, 10.1111/j.1538-7836.2008.03180.x

D Appelen, 2017, Compression therapy for prevention of post-thrombotic syndrome, Cochrane Database Syst Rev, 9, CD004174

C Kearon, 2016, Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report, Chest, 149, 315, 10.1016/j.chest.2015.11.026

E E Amin, 2018, Reduced incidence of vein occlusion and postthrombotic syndrome after immediate compression for deep vein thrombosis, Blood, 132, 2298, 10.1182/blood-2018-03-836783

L Watson, 2016, Thrombolysis for acute deep vein thrombosis, Cochrane Database Syst Rev, 11, CD002783

A J Comerota, 2007, Treatment of acute iliofemoral deep venous thrombosis: a strategy of thrombus removal, Eur J Vasc Endovasc Surg, 33, 351, 10.1016/j.ejvs.2006.11.013

T Enden, 2009, Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short-term patency, J Thromb Haemost, 7, 1268, 10.1111/j.1538-7836.2009.03464.x

S Parikh, 2008, Ultrasound-accelerated thrombolysis for the treatment of deep vein thrombosis: initial clinical experience, J Vasc Interv Radiol, 19, 521, 10.1016/j.jvir.2007.11.023

A Motarjeme, 2007, Ultrasound-enhanced thrombolysis, J Endovasc Ther, 14, 251, 10.1177/152660280701400218

P Notten, 2020, Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial, Lancet Haematol, 7, e40, 10.1016/S2352-3026(19)30209-1

S Vedantham, 2017, Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis, N Engl J Med, 377, 2240, 10.1056/NEJMoa1615066

Y Haig, 2016, Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial, Lancet Haematol, 3, e64, 10.1016/S2352-3026(15)00248-3

T Enden, 2012, Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial, Lancet, 379, 31, 10.1016/S0140-6736(11)61753-4

Y Haig, 2013, Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis, J Vasc Interv Radiol, 24, 17, 10.1016/j.jvir.2012.09.023

S Vedantham, 2014, Quality improvement guidelines for the treatment of lower-extremity deep vein thrombosis with use of endovascular thrombus removal, J Vasc Interv Radiol, 25, 1317, 10.1016/j.jvir.2014.04.019

S R Kahn, 2009, Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization, J Thromb Haemost, 7, 879, 10.1111/j.1538-7836.2009.03294.x

S R Kahn, 2009, Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome, J Thromb Haemost, 7, 884, 10.1111/j.1538-7836.2009.03339.x

S BP Villalta, 1994, Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome. [Abstract], Haemostasis, 24, 158a

R B Rutherford, 2000, Venous severity scoring: an adjunct to venous outcome assessment, J Vasc Surg, 31, 1307, 10.1067/mva.2000.107094

N K Aaronson, 1998, Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations, J Clin Epidemiol, 51, 1055, 10.1016/S0895-4356(98)00097-3

R Brooks, 1996, EuroQol: the current state of play, Health Policy, 37, 53, 10.1016/0168-8510(96)00822-6

J M Bland, 2015, Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial, BMC Cardiovasc Disord, 15, 85, 10.1186/s12872-015-0080-7

S K van der Velden, 2014, Translation and validation of the Dutch VEINES-QOL/Sym in varicose vein patients, Phlebology, 29, 227, 10.1177/0268355513476279

D L Lamping, 2003, Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life, J Vasc Surg, 37, 410, 10.1067/mva.2003.152

C A Pollard, 1984, Preliminary validity study of the pain disability index, Percept Mot Skills, 59, 974, 10.2466/pms.1984.59.3.974

R H Strijkers, 2015, Validation of the LET classification, Phlebology, 30, 14, 10.1177/0268355515569133

G R Norman, 2003, Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation, Med Care, 41, 582, 10.1097/01.MLR.0000062554.74615.4C

S J Walters, 2005, Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D, Qual Life Res, 14, 1523, 10.1007/s11136-004-7713-0

S Petersohn, 2019, Comparison of three generic quality-of-life metrics in peripheral arterial disease patients undergoing conservative and invasive treatments, Qual Life Res, 28, 2257, 10.1007/s11136-019-02166-0

I Weinberg, 2019, Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: results from the ATTRACT multicenter randomized trial, Vasc Med, 24, 442, 10.1177/1358863X19862043

J M White, 2017, Venous compression syndromes, Vasc Endovascular Surg, 51, 155, 10.1177/1538574417697208

A J Comerota, 2012, Postthrombotic morbidity correlates with residual thrombus following catheter-directed thrombolysis for iliofemoral deep vein thrombosis, J Vasc Surg, 55, 768, 10.1016/j.jvs.2011.10.032

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Thrombosis and Haemostasis

Tập 120 Số 08

1188-1199

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