A Prospective Randomized Trial of Catheter-Directed Thrombolysis With Additional Balloon Dilatation for Iliofemoral Deep Venous Thrombosis: A Single-Center Experience

详细信息    查看全文

• 作者：Xiaoqin Zhang (1)
  Qingshuai Ren (1)
  Xuemei Jiang (2)
  Jianming Sun (1)
  Jianping Gong (3)
  Bo Tang (1)
  Yikuan Chen (1)
  
• 关键词：Deep venous thrombosis ; Iliofemoral thrombosis ; Thrombolysis ; Dilatation ; Venous intervention
• 刊名：CardioVascular and Interventional Radiology
• 出版年：2014
• 出版时间：August 2014
• 年：2014
• 卷：37
• 期：4
• 页码：958-968
• 全文大小：305 KB
• 参考文献：1. Oger E (2000) Incidence of venous thromboembolism: a community-based study in Western France. Thromb Haemost 83:657-60
  2. Lee CH, Cheng CL, Lin LJ, Tsai LM, Yang YH (2011) Epidemiology and predictors of short-term mortality in symptomatic venous thromboembolism. Circ J 75:1998-004 CrossRef
  3. Delis KT, Bountouroglou D, Mansfield AO (2004) Venous claudication in iliofemoral thrombosis: long-term effects on venous hemodynamics, clinical status, and quality of life. Ann Surg 239:118-26 CrossRef
  4. Douketis JD, Crowther MA, Foster GA, Ginsberg JS (2001) Does the location of thrombosis determine the risk of disease recurrence in patients with proximal deep vein thrombosis? Am J Med 110:515-19 CrossRef
  5. Kahn SR, Shrier I, Julian JA et al (2008) Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med 149:698-07 CrossRef
  6. Hull RD, Raskob GE, Brant RF, Pineo GF, Valentine KA (1997) Relation between the time to achieve the lower limit of the APTT therapeutic range and the recurrent venous thromboembolism during heparin treatment for deep vein thrombosis. Arch Intern Med 157:2562-568 CrossRef
  7. Quinlan DJ, McQuillan A, Eikelboom JW (2004) Low-molecular-weight heparin compared with intravenous unfractionated heparin for treatment of pulmonary embolism: a meta-analysis of randomized, controlled trials. Ann Intern Med 140:175-83 CrossRef
  8. Arcasoy SM, Vachani A (2003) Local and systemic thrombolytic therapy for acute venous thromboembolism. Clin Chest Med 24:73-1 CrossRef
  9. Mewissen MW, Seabroook GR, Meissner MH et al (1999) Catheter-directed thrombolysis for lower extremity deep vein thrombosis: report of a national multicenter registry. Radiology 211:39-9 CrossRef
  10. Frisoli JK, Sze D (2003) Mechanical thrombectomy for the treatment of lower extremity deep vein thrombosis. Tech Vasc Interv Radiol 6:49-2 CrossRef
  11. Kearon C, Ginsberg JS, Hirsh J (1998) The role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism. Ann Intern Med 129:1044-049 CrossRef
  12. Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L (2003) Evaluating 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 37:410-19 CrossRef
  13. McHorney CA, Ware JE Jr, Raczek AE (1993) The MOS 36-item short form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31:247-63 CrossRef
  14. Vedantham S, Grassi CJ, Ferral H et al (2006) Technology Assessment Committee of the Society of Interventional Radiology. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol 17:417-34 CrossRef
  15. Hann CL, Streiff MB (2005) The role of vena caval filters in the management of venous thromboembolism. Blood Rev 19:179-02 CrossRef
  16. Villalta S, Bagatella P, Piccioli A et al (1994) Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome (abstract). Haemostasis 24:158a
  17. Streiner DL, Norman GR (1995) Health measurement scales: a practical guide to their development and use, 2nd edn. Oxford University Press, Oxford
  18. Sherry S (1985) Thrombolytic therapy for deep venous thrombosis. Semin Intervent Radiol 4:331-37
  19. Popuri RK, Vedantham S (2011) The role of thrombolysis in the clinical management of deep vein thrombosis. Arterioscler Thromb Vasc Biol 31:479-84 CrossRef
  20. Meissner MH (2002) Thrombolytic therapy for acute deep vein thrombosis and the venous registry. Rev Cardiovasc Med 3:S53–S60
  21. Frisoli JK, Sze D (2003) Mechanical thrombectomy for the treatment of lower extremity deep vein thrombosis. Tech Vasc Interv Radiol 6:49-2 CrossRef
  22. Xie H, Kim K, Aglyamov SR et al (2004) Staging deep venous thrombosis using ultrasound elasticity imaging: animal model. Ultrasound Med Biol 30:1385-396 CrossRef
  23. Geier B, Barbera L, Muth-Werthmann D et al (2005) Ultrasound elastography for the age determination of venous thrombi. Evaluation in an animal model of venous thrombosis. Thromb Haemost 93:368-74
  24. Chen YK, Jiang XM, Gong JP (2008) Recombinant human granulocyte colony-stimulating factor enhanced the resolution of venous thrombi. J Vasc Surg 47:1058-065 CrossRef
  25. Perrier A, Bounameaux H (2013) Catheter-directed thrombolysis for deep venous thrombosis might be cost-effective, but for whom? J Thromb Haemost [Epub ahead of print]
  26. Grommes J, Strijkers R, Greiner A, Mahnken AH, Wittens CH (2011) Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc Endovasc Surg 41:526-32 CrossRef
  27. Baker R, Samuels S, Benenati JF, Powell A, Uthoff H (2012) Ultrasound-accelerated vs standard catheter-directed thrombolysis—a comparative study in patients with iliofemoral deep vein thrombosis. J Vasc Interv Radiol 23:1460-466 CrossRef
  28. Oguzkurt L, Ozkan U, Demirturk OS, Gur S (2011) Endovascular treatment of phlegmasia cerulea dolens with impending venous gangrene: manual aspiration thrombectomy as the first-line thrombus removal method. Cardiovasc Intervent Radiol 34:1214-221
  29. Bush RL, Lin PH, Bates JT et al (2004) Pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis: safety and feasibility study. J Vasc Surg 40:965-70 CrossRef
  30. Vedantham S (2012) Interventional approaches to deep vein thrombosis. Am J Hematol 87(Suppl 1):S113–S118 CrossRef
  31. Vena Caval Filter Consensus Conference (1999) Recommended reporting standards for vena caval filter placement and patient follow-up. J Vasc Surg 30:573-79 CrossRef
  32. Protack CD, Bakken AM, Patel N et al (2007) Long-term outcomes of catheter directed thrombolysis for lower extremity deep venous thrombosis without prophylactic inferior vena cava filter placement. J Vasc Surg 45:992-97 CrossRef
  33. PREPIC Study Group (2005) Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d’Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 112:416-22 CrossRef
  34. Yeung LY, Hastings GS, Alexander JQ (2010) Endovascular retrieval of inferior vena cava filter penetrating into aorta: an unusual presentation of abdominal pain. Vasc Endovascular Surg 44:683-86 CrossRef
  35. Stein PD, Matta F, Hull RD (2011) Increasing use of vena cava filters for prevention of pulmonary embolism. Am J Med 124:655-61 CrossRef
  36. Nazzal M, Chan E, Nazzal M et al (2010) Complications related to inferior vena cava filters: a single-center experience. Ann Vasc Surg 24:480-86 CrossRef
  
• 作者单位：Xiaoqin Zhang (1)
  Qingshuai Ren (1)
  Xuemei Jiang (2)
  Jianming Sun (1)
  Jianping Gong (3)
  Bo Tang (1)
  Yikuan Chen (1)
  
  1. Department of Vascular Surgery, Second Affiliated Hospital, Chongqing Medical University, 76 Linjiang Rd, Yuzhong District, Chongqing, 400010, People’s Republic China
  2. Department of Haematology, Second Affiliated Hospital, Chongqing Medical University, 76 Linjiang Rd, Yuzhong District, Chongqing, 400010, People’s Republic China
  3. Department of Hepatobiliary Surgery, Second Affiliated Hospital, Chongqing Medical University, 76 Linjiang Rd, Yuzhong District, Chongqing, 400010, People’s Republic China
  
• ISSN：1432-086X

文摘

Purpose Catheter-directed thrombolysis (CDT) is effective for acute iliofemoral deep venous thrombosis (DVT), but CDT remains partially effective for subacute DVT. The aim of this study was to conduct a prospective randomized controlled single-centre clinical trial to compare CDT alone with CDT with additional balloon dilatation for the treatment of iliofemoral DVT. Methods The trial was performed between February 2007 and January 2011. Iliofemoral DVT patients lacking effective therapy before enrollment were randomly assigned either to CDT (control group) or to CDT with additional balloon dilatation (intervention group). Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL), Severity of Venous Lower Limb Symptoms (VEINES-Sym), 36-Item Short-Form Health Survey (SF-36), and Villalta scores were obtained at scheduled follow-up. Results Seven hundred twenty-two patients were screened, and 386 eligible patients were randomized. No significant difference for mean total Villalta score was observed between the intervention group (4.20?±?3.05) and the control group (4.89?±?3.45). However, post hoc analysis of the scores in subacute patients showed significant differences between the intervention group and the control group from 1?month (6.79?±?4.23, 8.28?±?5.03, P?=?0.02) to 24?months (4.21?±?3.08, 5.67?±?3.71, P?=?0.006). A significant difference was also observed in subacute patients at the end of follow-up for VEINES-QOL/Sym (52.87?±?6.52, 50.31?±?6.07, P?=?0.009; 51.87?±?6.37, 49.72?±?5.96, P?=?0.02) and SF-36 PCS/MCS (45.02?±?12.07, 41.13?±?11.68, P?=?0.03; 53.26?±?11.43, 49.50?±?11.06, P?=?0.03). Conclusion Subacute iliofemoral DVT patients lacking effective therapy during acute phase, might receive more benefits from CDT with additional balloon dilatation. However, CDT alone is highly effective for acute patients.