Lack of consistency in the relationship between asymptomatic DVT detected by venography and symptomatic VTE in thromboprophylaxis trials

Thrombosis and Haemostasis

Volumn 114, Issue 5, 2015, Pages 1049-1057

  Chan, Noel C ^a   Stehouwer, Alexander C ^d   Hirsh, Jack ^c   Ginsberg, Jeffrey S ^b,c   Alazzoni, Ashraf ^c   Coppens, Michiel ^e   Guyatt, Gordon H ^c   Eikelboom, John W ^a,b,c  

^a MCMASTER UNIVERSITY   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c MCMASTER UNIVERSITY   (Canada)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

Clinical trials; Heparins LMWH; Oral anticoagulants; Surrogate marker; Venography; Venous thrombosis

Indexed keywords

APIXABAN; BEMIPARIN; DABIGATRAN; DALTEPARIN; DESULFATOHIRUDIN; ENOXAPARIN; FONDAPARINUX; RIVAROXABAN; TINZAPARIN; ANTICOAGULANT AGENT;

DEEP VEIN THROMBOSIS; DISEASE MARKER; HIP FRACTURE; HUMAN; OUTCOME ASSESSMENT; PHLEBOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; THROMBOSIS PREVENTION; TOTAL HIP PROSTHESIS; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM; ASYMPTOMATIC DISEASE; HEMORRHAGE; ORTHOPEDIC SURGERY; POSTOPERATIVE COMPLICATIONS; PROCEDURES; RISK ASSESSMENT; THROMBOSIS; VENOUS THROMBOSIS;

ANTICOAGULANTS; ASYMPTOMATIC DISEASES; HEMORRHAGE; HUMANS; ORTHOPEDIC PROCEDURES; OUTCOME ASSESSMENT (HEALTH CARE); PHLEBOGRAPHY; POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; THROMBOSIS; VENOUS THROMBOSIS;

EID: 84946554533     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH14-12-1006     Document Type: Review

References (37)

1. Collins R, Scrimgeour A, Yusuf S, et al. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. New Engl J Med 1988; 318: 1162–1173.
2. Falck-Ytter Y, Francis CW, Johanson NA, et al.. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e278S-325S.
3. Guyatt GH, Eikelboom JW, Gould MK, et al. Approach to outcome measurement in the prevention of thrombosis in surgical and medical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e185S-194S.
4. Berger J, Eikelboom JW, Quinlan DJ, et al. Venous thromboembolism prophylaxis: do trial results enable clinicians and patients to evaluate whether the benefits justify the risk? Proceedings of an Ad Hoc Working Group Meeting. J Thromb Haemost 2013; 11: 778–782.
5. Segers AEM, Prins MH, Lensing AWA, et al. Is contrast venography a valid surrogate outcome measure in venous thromboembolism prevention studies? J Thromb Haemost 2005; 3: 1099–1102.
6. Quinlan DJ, Eikelboom JW, Dahl OE, et al. Association between asymptomatic deep vein thrombosis detected by venography and symptomatic venous thromboembolism in patients undergoing elective hip or knee surgery. J Thromb Haemost 2007; 5: 1438–1443.
7. Hirsh J, Ginsberg JS, Chan N, et al. Mandatory contrast-enhanced venography to detect deep-vein thrombosis (DVT) in studies of DVT prophylaxis: upsides and downsides. Thromb Haemost 2014; 111: 10–13.
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest 2012; 141: e195S-e226S.
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in non orthopedic surgical patients: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest 2012; 141: e227S-e277S.
10. Guyatt GH, Norris SL, Schulman S, et al. Methodology for the development of antithrombotic therapy and prevention of thrombosis guidelines: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest 2012; 141: 53S-70S.
11. Eriksson BI, Dahl OE, Huo MH, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE 2). A randomised, double-blind, non-inferiority trial. Thromb Haemost 2011; 105: 721–729.
12. Lassen MR, Gallus A, Raskob GE, et al. Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement. New Engl J Med 2010; 363: 2487–2498.
13. Kakkar AK, Brenner B, Dahl OE, et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372: 31–39.
14. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty. New Engl J Med 2008; 358: 2765–2775.
15. Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007; 370: 949–956.
16. Lassen MR, Bauer KA, Eriksson BI, et al. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet 2002; 359: 1715–1720.
17. Turpie AGG, Bauer KA, Eriksson BI, et al. Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: a randomised double-blind trial. Lancet 2002; 359: 1721–1726.
18. Hull RD, Pineo GF, Francis C, et al. Low-molecular-weight heparin prophylaxis using dalteparin extended out-of-hospital vs in-hospital warfarin/out-of-hospital placebo in hip arthroplasty patients: a double-blind, randomized comparison. North American Fragmin Trial Investigators. Archives of internal medicine. 2000; 160: 2208–2215.
19. Eriksson BI, Wille-Jørgensen P, Kälebo P, et al. A Comparison of Recombinant Hirudin with a Low-Molecular-Weight Heparin to Prevent Thromboembolic Complications after Total Hip Replacement. New Engl J Med 1997; 337: 1329–1335.
20. Hull R, Raskob G, Pineo G, et al. A comparison of subcutaneous low-molecularweight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. New Engl J Med 1993; 329: 1370–1376.
21. Lassen MR, Raskob GE, Gallus A, et al. Apixaban or Enoxaparin for Thromboprophylaxis after Knee Replacement. New Engl J Med 2009; 361: 594–604.
22. Lassen MR, Raskob GE, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised doubleblind trial. Lancet 2010; 375: 807–815.
23. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673–1680.
24. Ginsberg JS, Davidson BL, Comp PC, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009; 24: 1–9.
25. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Total Knee Arthroplasty. New Engl J Med 2008; 358: 2776–2786.
26. Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: 2178–2185.
27. Bauer KA, Eriksson BI, Lassen MR, et al. Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Elective Major Knee Surgery. New Engl J Med 2001; 345: 1305–1310.
28. Eriksson BI, Bauer KA, Lassen MR, et al. Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Hip-Fracture Surgery. New Engl J Med 2001; 345: 1298–1304.
29. Eriksson BI, Lassen MR. Duration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery: a multicenter, randomized, placebo-controlled, double-blind study. Arch Intern Med 2003; 163: 1337–1342.
30. ENOXACAN Study Group. Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery: a double-blind randomized multicentre trial with venographic assessment. Br J Surg 1997; 84: 1099–1103.
31. McLeod RS, Geerts WH, Sniderman KW, et al. Subcutaneous heparin versus low-molecular-weight heparin as thromboprophylaxis in patients undergoing colorectal surgery: results of the Canadian colorectal DVT prophylaxis trial: a randomized, double-blind trial. Ann Surg 2001; 233: 438–444.
32. Agnelli G, Bergqvist D, Cohen AT, et al. Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Br J Surg 2005; 92: 1212–1220.
33. Turpie AG, Bauer KA, Caprini JA, et al. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. J Thromb Haemost 2007; 5: 1854–1861.
34. Kakkar VV, Balibrea JL, Martinez-Gonzalez J, et al. Extended prophylaxis with bemiparin for the prevention of venous thromboembolism after abdominal or pelvic surgery for cancer: the CANBESURE randomized study. J Thromb Haemost 2010; 8: 1223–1229.
35. Samama MM, Cohen AT, Darmon J-Y, et al. A Comparison of Enoxaparin with Placebo for the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients. New Engl J Med 1999; 341: 793–800.
36. Cohen AT, Davidson BL, Gallus AS, et al., for the ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. Br Med J 2006; 332: 325–329.
37. European Medicines Agency. Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143764.pdf. Accessed 08/02/2015.