提示: 手机请竖屏浏览!

膝关节镜和小腿石膏固定后的血栓预防
Thromboprophylaxis after Knee Arthroscopy and Lower-Leg Casting


Raymond A. van Adrichem ... 心脑血管疾病 其他 • 2017.02.09

摘要


背景

在膝关节镜或小腿石膏固定后采取血栓预防措施来预防临床显性静脉血栓栓塞的做法目前存在争论。我们在术后接受抗凝剂治疗和未接受抗凝剂治疗的患者之间比较了有症状的静脉血栓形成的发生率。

 

方法

我们进行了两项平行、实效性、多中心、随机对照、开放性试验,并采用盲法进行结局评估:POT-KAST试验——入组接受膝关节镜的患者,以及POT-CAST试验——入组接受小腿石膏固定的患者。患者被分配至接受预防剂量的低分子肝素治疗(POT-KAST试验中为关节镜后持续8日,而POT-CAST试验中为因石膏固定而制动的全程阶段)或不接受抗凝剂治疗。主要结局为术后3个月内有症状的静脉血栓栓塞和严重出血事件的累计发生率。

 

结果

在POT-KAST试验中,1,543例患者接受了随机化,其中1,451例患者纳入了意向治疗人群。治疗组731例患者中有5例(0.7%)发生了静脉血栓栓塞,而对照组720例患者中有3例(0.4%)发生了静脉血栓栓塞(相对危险度1.6;95%置信区间[CI] 0.4~6.8;危险度绝对差异0.3个百分点;95% CI -0.6~1.2)。治疗组有1例患者(0.1%)发生严重出血事件,对照组有1例患者(0.1%)发生严重出血事件(危险度绝对差异0个百分点;95% CI -0.6~0.7)。在POT-CAST试验中,1,519例患者接受了随机化,其中1,435例患者纳入了意向治疗人群。治疗组719例患者中有10例(1.4%)患者发生了静脉血栓栓塞,而对照组716例患者中13例(1.8%)发生了静脉血栓栓塞(相对危险度0.8;95% CI 0.3~1.7;危险度绝对差异-0.4个百分点;95% CI -1.8~1.0)。无严重出血事件发生。在两项试验中,最常见的不良事件为感染。

 

结论

我们的试验结果表明,使用低分子肝素在膝关节镜后8日内,或因石膏固定而制动的全程阶段中进行血栓预防不能有效地预防有症状的静脉血栓栓塞(试验由荷兰健康研究与发展组织[Netherlands Organization for Health Research and Development]资助;POT-KAST和POT-CAST试验在ClinicalTrials.gov上的注册号分别为NCT01542723和NCT01542762)。





作者信息

Raymond A. van Adrichem, M.D., Banne Nemeth, M.D., Ale Algra, M.D., Ph.D., Saskia le Cessie, Ph.D., Frits R. Rosendaal, M.D., Ph.D., Inger B. Schipper, M.D., Ph.D., Rob G.H.H. Nelissen, M.D., Ph.D., and Suzanne C. Cannegieter, M.D., Ph.D., for the POT-KAST and POT-CAST Group*
From the Departments of Clinical Epidemiology (R.A.A., B.N., A.A., S.C., F.R.R., S.C.C.), Orthopedic Surgery (R.A.A., B.N., R.G.H.H.N.), Medical Statistics and Bioinformatics (S.C.), Trauma Surgery (I.B.S.), and Thrombosis and Hemostasis (S.C.C.), Leiden University Medical Center, Leiden, and Julius Center for Health Sciences and Patient Care, University Medical Center Utrecht, Utrecht (A.A.) — both in the Netherlands. Address reprint requests to Dr. Cannegieter at the Department of Clinical Epidemiology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC Leiden, the Netherlands, or at s.c.cannegieter@lumc.nl. *A complete list of investigators in the Prevention of Thrombosis after Knee Arthroscopy (POT-KAST) and the Prevention of Thrombosis after Lower Leg Plaster Cast (POT-CAST) trials is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. van Adrichem RA, Nelissen RG, Schipper IB, Rosendaal FR, Cannegieter SC. Risk of venous thrombosis after arthroscopy of the knee: results from a large population-based case-control study. J Thromb Haemost 2015;13:1441-1448

2. van Adrichem RA, Debeij J, Nelissen RG, Schipper IB, Rosendaal FR, Cannegieter SC. Below-knee cast immobilization and the risk of venous thrombosis: results from a large population-based case-control study. J Thromb Haemost 2014;12:1461-1469

3. Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrøm J. Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost 2007;5:692-699

4. ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost 2014;12:1580-1590

5. Ashrani AA, Heit JA. Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis 2009;28:465-476

6. American Academy of Orthopaedic Surgeons. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty (http://www.orthoguidelines.org/guideline-detail?id=1075).

7. 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(2 Suppl):e278S-e325S.

8. National Institute for Health and Care Excellence. Venous thromboembolism: reducing the risk for patients in hospital. NICE guideline CG92. 2010 (https://www.nice.org.uk/guidance/cg92).

9. American Academy of Orthopaedic Surgeons. Knee arthroscopy (http://orthoinfo.aaos.org/topic.cfm?topic=a00299).

10. Jørgensen PS, Warming T, Hansen K, et al. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res 2002;105:477-480

11. Kock HJ, Schmit-Neuerburg KP, Hanke J, Rudofsky G, Hirche H. Thromboprophylaxis with low-molecular-weight heparin in outpatients with plaster-cast immobilisation of the leg. Lancet 1995;346:459-461

12. Lapidus LJ, Ponzer S, Elvin A, et al. Prolonged thromboprophylaxis with Dalteparin during immobilization after ankle fracture surgery: a randomized placebo-controlled, double-blind study. Acta Orthop 2007;78:528-535

13. Lassen MR, Borris LC, Nakov RL. Use of the low-molecular-weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization. N Engl J Med 2002;347:726-730

14. ProMISe (Project Manager Internet Server). About ProMISe (https://www.msbi.nl/promise).

15. Schulman S, Angerås U, Bergqvist D, Eriksson B, Lassen MR, Fisher W. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 2010;8:202-204

16. Ramos J, Perrotta C, Badariotti G, Berenstein G. Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy. Cochrane Database Syst Rev 2008;4:CD005259-CD005259

17. Camporese G, Bernardi E, Prandoni P, et al. Low-molecular-weight heparin versus compression stockings for thromboprophylaxis after knee arthroscopy: a randomized trial. Ann Intern Med 2008;149:73-82

18. Testroote M, Stigter W, de Visser DC, Janzing H. Low molecular weight heparin for prevention of venous thromboembolism in patients with lower-leg immobilization. Cochrane Database Syst Rev 2008;4:CD006681-CD006681

19. Comp PC, Spiro TE, Friedman RJ, et al. Prolonged enoxaparin therapy to prevent venous thromboembolism after primary hip or knee replacement J Bone Joint Surg Am 2001;83-A:336-345

20. Lassen MR, Borris LC, Anderson BS, et al. Efficacy and safety of prolonged thromboprophylaxis with a low molecular weight heparin (dalteparin) after total hip arthroplasty — the Danish Prolonged Prophylaxis (DaPP) Study. Thromb Res 1998;89:281-287

21. Sobieraj DM, Lee S, Coleman CI, et al. Prolonged versus standard-duration venous thromboprophylaxis in major orthopedic surgery: a systematic review. Ann Intern Med 2012;156:720-727

22. Camporese G, Bernardi E, Noventa F, et al. Efficacy of Rivaroxaban for thromboprophylaxis after Knee Arthroscopy (ERIKA): a phase II, multicentre, double-blind, placebo-controlled randomised study. Thromb Haemost 2016;116:349-355

23. Nemeth B, van Adrichem RA, Cannegieter SC. The ERIKA trial: still limited evidence on the efficacy of thromboprophylaxis after knee arthroscopy. Thromb Haemost 2016;116:1001-1001

24. Testroote M, Stigter WA, Janssen L, Janzing HM. Low molecular weight heparin for prevention of venous thromboembolism in patients with lower-leg immobilization. Cochrane Database Syst Rev 2014;4:CD006681-CD006681

25. Bushnell BD, Anz AW, Bert JM. Venous thromboembolism in lower extremity arthroscopy. Arthroscopy 2008;24:604-611

26. Mauck KF, Froehling DA, Daniels PR, et al. Incidence of venous thromboembolism after elective knee arthroscopic surgery: a historical cohort study. J Thromb Haemost 2013;11:1279-1286

27. Krych AJ, Sousa PL, Morgan JA, Levy BA, Stuart MJ, Dahm DL. Incidence and risk factor analysis of symptomatic venous thromboembolism after knee arthroscopy. Arthroscopy 2015;31:2112-2118

28. Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. BMJ 2015;350:h2747-h2747

29. Bergqvist D, Arcelus JI, Felicissimo P,ETHOS investigators. . Post-discharge compliance to venous thromboembolism prophylaxis in high-risk orthopaedic surgery: results from the ETHOS registry. Thromb Haemost 2012;107:280-287

30. Forster R, Stewart M. Anticoagulants (extended duration) for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair. Cochrane Database Syst Rev 2016;3:CD004179-CD004179

31. Rosendaal FR. Venous thrombosis: a multicausal disease. Lancet 1999;353:1167-1173

32. Nemeth B, van Adrichem RA, van Hylckama Vlieg A, et al. Venous thrombosis risk after cast immobilization of the lower extremity: derivation and validation of a clinical prediction score, L-TRiP(cast), in three population-based case-control studies. PLoS Med 2015;12:e1001899-e1001899

33. Nemeth B, van Adrichem RA, le Cessie S, et al. Prediction of venous thrombosis risk after arthroscopy of the knee. Presented at the International Society on Thrombosis and Haemostasis 2015 Congress, Toronto, June 20–25, 2015 (poster).

服务条款 | 隐私政策 | 联系我们