The American Journal of Medicine
Volume 122, Issue 8 , Pages 762-769.e3 , August 2009

Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome

  • Russell D. Hull, MBBS, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
    • Corresponding Author InformationRequests for reprints should be addressed to Russell D. Hull, MBBS, MSc, Thrombosis Research Unit, 601 South Tower, Foothills Hospital, 1403-29th Street NW, Calgary, AB T2N 2T9, Canada
  • ,
  • Graham F. Pineo, MD

      Affiliations

    • University of Calgary, Calgary, AB, Canada
  • ,
  • Rollin Brant, PhD

      Affiliations

    • University of British Columbia, Vancouver, BC, Canada
  • ,
  • Jane Liang, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
  • ,
  • Roy Cook, MD

      Affiliations

    • University of Calgary, Calgary, AB, Canada
  • ,
  • Susan Solymoss, MD

      Affiliations

    • McGill University, Montreal, QC, Canada
  • ,
  • Man-Chiu Poon, MD, MSc

      Affiliations

    • University of Calgary, Calgary, AB, Canada
  • ,
  • Gary Raskob, PhD

      Affiliations

    • College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City
  • ,
  • LITE Trial Investigators

References 

  1. Buller HR, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):401S–428S
  2. Kearon C, Kahn SR, Agnelli G, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, 8th Edition). Chest. 2008;133:454S–545S
  3. Hull RD, Pineo GF, Brant RF, et al. LITE Trial Investigators Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med. 2006;119:1062–1072
  4. Hull RD, Pineo GF, Brant RF, et al. LITE Trial Investigators Self-managed long-term low-molecular-weight heparin therapy: the balance of benefits and harms. Am J Med. 2007;120:72–82
  5. Kahn SR, Kearon C, Julian JA, et al. Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005;3:718–723
  6. Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006;21:41–48
  7. Prandoni P, Lensing AW, Prins MH, et al. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004;141:249–256
  8. Prandoni P, Frulla M, Sartor D, et al. Venous abnormalities and the post-thrombotic syndrome. J Thromb Haemost. 2005;3:401–402
  9. Vedantham S. Interventional approaches to acute venous thromboembolism. Semin Respir Crit Care Med. 2008;29:56–65
  10. Hyers TM, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease. Chest. 2001;119(1 Suppl):176S–193S
  11. PIOPED Investigators. Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). JAMA. 1990;263:2753–2759
  12. Freitas JE, Sarosi MG, Nagle CC, et al. Modified PIOPED criteria used in clinical practice. J Nucl Med. 1995;36:1573–1578
  13. Stewart AL, Ware JE. Measuring Functioning and Well-being: The Medical Outcomes Study Approach. Durham, NC: Duke University Press; 1992;
  14. Koopman MM, Prandoni P, Piovella F, et al. The Tasman Study Group Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. N Engl J Med. 1996;334:682–687
  15. Lancaster TR, Singer DE, Sheehan MA, et al. The impact of long-term warfarin therapy on quality of life (Evidence from a randomized trial. Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators). Arch Intern Med. 1991;151:1944–1949
  16. Rodger MA, Gagné-Rodger C, Howley HE, et al. The outpatient treatment of deep vein thrombosis delivers cost savings to patients and their families, compared to inpatient therapy. Thromb Res. 2003;112:13–18
  17. Hedner E, Carlsson J, Kulich KR, et al. An instrument for measuring health-related quality of life in patients with deep venous thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire. Health Qual Life Outcomes. 2004;2:30
  18. Villalta S, Bagatella P, Piccioli A, et al. Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome [abstract]. Haemostasis. 1994;24:158a
  19. Brandjes DP, Büller HR, Heijboer H, et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997;349:759–762
  20. Pini M, Aiello S, Manotti C, et al. Low molecular weight heparin versus warfarin in the prevention of recurrences after deep vein thrombosis. Thromb Haemost. 1994;72:191–197
  21. Das SK, Cohen AT, Edmondson RA, et al. Low-molecular-weight heparin versus warfarin for prevention of recurrent venous thromboembolism: a randomized trial. World J Surg. 1996;20:521–526
  22. Gonzalez-Fajardo JA, Arreba E, Castrodeza J, et al. Venographic comparison of subcutaneous low-molecular weight heparin with oral anticoagulant therapy in the long-term treatment of deep venous thrombosis. J Vasc Surg. 1999;30:283–292
  23. Lopaciuk S, Bielska-Falda H, Noszczyk W, et al. Low molecular weight heparin versus acenocoumarol in the secondary prophylaxis of deep vein thrombosis. Thromb Haemost. 1999;81:26–31
  24. Veiga F, Escribá A, Maluenda MP, et al. Low molecular weight heparin (enoxaparin) versus oral anticoagulant therapy (acenocoumarol) in the long-term treatment of deep venous thrombosis in the elderly: a randomized trial. Thromb Haemost. 2000;84:559–564
  25. López-Beret P, Orgaz A, Fontcuberta J, et al. Low molecular weight heparin versus oral anticoagulants in the long-term treatment of deep venous thrombosis. J Vasc Surg. 2001;33:77–90
  26. Kakkar VV, Gebska M, Kadziola Z, et al. Bemiparin Investigators Low-molecular-weight heparin in the acute and long-term treatment of deep vein thrombosis. Thromb Haemost. 2003;89:674–680
  27. Daskalopoulos ME, Daskalopoulou SS, Tzortzis E, et al. Long-term treatment of deep venous thrombosis with a low molecular weight heparin (tinzaparin): a prospective randomized trial. Eur J Vasc Endovasc Surg. 2005;29:638–650
  28. Lee AY, Levine MN, Baker RI, et al. Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003;349:146–153
  29. Agnelli G, Becattini C. Treatment of DVT: how long is enough and how do you predict recurrence. J Thromb Thrombolysis. 2008;25:37–44
  30. Rodger MA, Kahn SR, Wells PS, et al. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008;179:417–426
  31. Siragusa S, Malato A, Anastasio R, et al. Residual vein thrombosis to establish duration of anticoagulation after a first episode of deep vein thrombosis: the Duration of Anticoagulation based on Compression UltraSonography (DACUS) study. Blood. 2008;112:511–515
  32. Kyrle PA, Minar E, Bialonczyk C, et al. The risk of recurrent venous thromboembolism in men and women. N Engl J Med. 2004;350:2558–2563
  33. Meyer G, Marjanovic Z, Valcke J, et al. Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med. 2002;162:1729–1735
  34. Jaeschke R, Guyatt GH, Cook D. Quality of life instruments in the evaluation of new drugs. Pharmacoeconomics. 1992;1:84–94
  35. Lamping DL, Schroter S, Kurz X, et al. 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;37:410–419
  36. Davey H, Barratt A, Butow P, Deeks J. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007;60:356–360
  37. Rodger MA, Kahn SR, Le Gal G, et al. Inter-observer reliability of measures to assess the post-thrombotic syndrome. Thromb Haemost. 2008;100:164–166
  38. Kahn SR, Shrier I, Julian JA. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008;149:698–707
  39. Daskalopoulos ME, Daskalopoulou SS, Prezas L, et al. Three-year follow-up of long-term deep venous thrombosis treatment with the low molecular weight heparin tinzaparin. Angiology. 2006;25(2 Suppl 1):76
  40. Daskalopoulos ME, Daskalopoulou SS, Liapis CD. Tinzaparin in long-term treatment of deep venous thrombosis. Eur J Vasc Endovasc Surg. 2007;34:353–354
  41. Hirsh J. Heparin and low-molecular-weight heparin (The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy). Chest. 2004;126:188S–203S
  42. Mousa SA. The low molecular weight heparin, tinzaparin, in thrombosis and beyond. Cardiovasc Drug Rev. 2002;20:199–216
  43. Kalani M, Apelqvist J, Blombäck M, et al. Effect of dalteparin on healing of chronic foot ulcers in diabetic patients with peripheral arterial occlusive disease: a prospective, randomized, double-blind, placebo-controlled study. Diabetes Care. 2003;26:2575–2580
  44. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaborations. Ann Intern Med. 2001;134:663–694
  45. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA. 2001;285:1987–1991
  46. Ioannidis JPA, Evans SJW, Gotzsche PC, et al. CONSORT Group Better reporting of harms in randomized trials: an extension of the CONSORT Statement. Ann Intern Med. 2004;141:781–788

 Funding: The study was supported by grants from the Medical Research Council (now Canadian Institutes for Health Research) and industry (LEO Pharma A/S Ltd., Ballerup, Denmark). Additional funding was provided by Pharmion and Dupont Pharmaceuticals. LEO Pharma provided the study drug and drug safety monitoring. The industry sponsors did not have any influence on the design or analysis of the study. The protocol was designed by 3 investigators. The Thrombosis Research Unit, University of Calgary, coordinated the study and carried out the data management and administrative duties. Statistical analysis was carried out independently of the industry sponsors by Rollin F. Brant, PhD, Department of Community Health Sciences, University of Calgary, Canada.

 Conflict of Interest: R. Hull has received grants/research support from Bayer Pharmaceuticals Corporation, LEO Pharma Inc., and sanofi-aventis; been a consultant for LEO Pharma, Inc., Pfizer Inc., and GlaxoSmithKline, and sat on advisory boards for Pfizer Inc. and sanofi-aventis. Graham Pineo is a consultant or advisory board member (or both): sanofi-aventis, Pfizer, and steering committee member for sanofi-aventis. Susan Solymoss has received honoraria from Pfizer and LEO-Pharma. Jane Liang, Man-Chiu Poon, Roy Cook, and Rollin Brant have no conflict of interest to declare. Gary Raskob receives consultant income or honoraria (or both) from the following companies: GlaxoSmithKline, Pfizer, and sanofi-aventis.

 Authorship: All authors had access to the data and contributed to/critically reviewed drafts of the manuscript.

PII: S0002-9343(09)00330-1

doi: 10.1016/j.amjmed.2008.12.023

The American Journal of Medicine
Volume 122, Issue 8 , Pages 762-769.e3 , August 2009