Symptom burden and job absenteeism after treatment with additional catheter-directed thrombolysis for deep vein thrombosis

Tone Enden, Nils-Einar Kløw, Per Morten Sandset, Tone Enden, Nils-Einar Kløw, Per Morten Sandset

Abstract

Introduction: Additional catheter-directed thrombolysis (CDT) for acute deep vein thrombosis (DVT) reduces long-term postthrombotic syndrome and is likely to represent a cost-effective alternative treatment compared to the standard treatment of anticoagulation and elastic compression stockings. Accelerated thrombus resolution has also been suggested to improve symptoms and patient function in the acute phase. We aimed to investigate whether additional CDT led to fewer symptoms and job absenteeism during the first 6 months after initiation of DVT treatment compared to standard treatment alone.

Methods: The Catheter-directed Venous Thrombolysis (CaVenT) study was a multicenter open label, randomized controlled trial of patients ages 18 years to 75 years with a verified high proximal DVT, <21 days of symptoms, and no apparent bleeding risk. Patients were allocated to additional CDT or to standard treatment only. Symptoms were assessed at baseline and at 6 months using items from the generic and disease-specific quality of life questionnaires EQ-5D and VEINES-QOL/Sym, respectively. Individual data on sickness benefits related to venous thromboembolic disease were obtained from the national welfare service.

Results: A total of 90 patients allocated additional CDT and 99 control patients completed long-term follow-up and were included in the analyses. Twenty-four in the CDT arm and 40 controls received sick leave (P = 0.046). When considering working patients only (54 in the CDT arm and 72 controls) this difference was no longer statistically significant. Mean duration of job absenteeism was 86.4 days (95% confidence interval 59.4-113.5) in the CDT arm and 60.1 days (95% confidence interval 42.3-77.8) in controls (P = 0.072). After 6 months, more controls experienced frequent swelling of the leg compared with those allocated to CDT (47 [49.0%] patients versus 25 [29.4%] patients, respectively, [P = 0.007]).

Conclusion: There are limitations to our data, but the findings indicate improved symptom relief and less frequent job absenteeism in patients treated with additional CDT; this expands upon previously established benefits from this treatment.

Keywords: patient reported outcomes; postthrombotic syndrome; randomized controlled trial; symptom burden; thrombolytic therapy; venous thrombosis.

References

    1. Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Kløw NE. Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis. J Vasc Interv Radiol. 2013;24(1):17–24.
    1. Enden T, Kløw NE, Sandvik L, et al. for CaVenT study group 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. 2009;7(8):1268–1275.
    1. Enden T, Haig Y, Kløw NE, et al. for CaVenT Study Group 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. 2012;379(9810):31–38.
    1. Kearon C, Akl EA, Comerota AJ, et al. for American College of Chest Physicians Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl 2):e419S–e494S.
    1. Enden T, Resch S, White C, Wik HS, Kløw NE, Sandset PM. Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis. J Thromb Haemost. 2013 Mar 2; Epub.
    1. Vedantham S, Grassi CJ, Ferral H, et al. for Technology Assessment Committee of the Society of Interventional Radiology Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol. 2009;20(Suppl 7):S391–S408.
    1. Enden T, Sandvik L, Kløw NE, et al. Catheter-directed venous thrombolysis in acute iliofemoral vein thrombosis – the CaVenT study: rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771) Am Heart J. 2007;154(5):808–814.
    1. Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. 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. 2003;37(2):410–419.
    1. Enden T, Garratt AM, Kløw NE, Sandset PM. Assessing burden of illness following acute deep vein thrombosis: data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym, a disease-specific questionnaire. Scand J Caring Sci. 2009;(2):369–374.
    1. Villalta S, Bagatella P, Piccioli A, Lensing AW, Prins MH, Prandoni P. Assessment of validity and reproducibility of a clinical scale for the postthrombotic syndrome. Haemostasis. 1994;24(Suppl 1):158a.
    1. Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C, for Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost. 2009;7(5):879–883.
    1. Enden T, Wik HS, Kvam AK, et al. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open. 2013;3:e002984.
    1. Floderus B, Göransson S, Alexanderson K, Aronsson G. Self-estimated life situation in patients on long-term sick leave. J Rehabil Med. 2005;37(5):291–299.
    1. Nord E. Health economics – short introduction to cost-benefit analyses. Tidsskr Nor Laegeforen. 2002;122(28):2719–2722. Norwegian.
    1. Bäckman K, Carlsson P, Kentson M, Hansen S, Engquist L, Hallert C. Deep venous thrombosis: a new task for primary health care. A randomised economic study of outpatient and inpatient treatment. Scand J Prim Health Care. 2004;22(1):44–49.
    1. Wik HS, Jacobsen AF, Sandvik L, Sandset PM. Long-term impact of pregnancy-related venous thrombosis on quality-of-life, general health and functioning: results of a cross-sectional, case-control study. BMJ Open. 2012;2(6):e002048.
    1. Kahn SR, Shrier I, Julian JA, et al. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008;149(10):698–707.
    1. Grovle L, Haugen AJ, Keller A, Natvig B, Brox JI, Grotle M. Poor agreement found between self-report and a public registry on duration of sickness absence. J Clin Epidemiol. 2012;65(2):212–218.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe