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Diz ve kalça artroplastisi sonrası ardışık terapi modalitelerinin (enoksaparin sonrası rivaroksaban veya dabigatran) tek başına enoksaparinkullanımı ile karşılaştırılması

Year 2015, Volume: 49 Issue: 3, 255 - 259, 17.07.2015
https://doi.org/10.3944/AOTT.2015.14.0219

Abstract

Amaç: Majör ortopedik cerrahiler sonrası venöz tromboembolizm ve pulmoner embolinin önlenmesi hayati önem taşır ve bu konuda yeni tedavi modaliteleri geliştirilmektedir. Bu çalışmada diz ve kalça artroplastisi sonrası ardışık terapi modalitelerinin (enoksaparin sonrası rivaroksaban veya dabigatran) tek başına enoksaparin kullanımı ile karşılaştırılmasını amaçladık.

Çalışma planı: Bu prospektif, randomize, körlü olmayan çalışmada; total diz artroplastisi veya total kalça artroplastisi operasyonu yapılan 247 hastanın arasından uygun olan 180 hastaya operasyon sonrası derin ven trombozu profilaksisi amacıyla sadece enoksaparin (enoksaparin grubu) veya ardışık terapi modaliteleri (hastanede yatış süresince enoksaparin ve taburculuk sonrası rivaroksaban veya dabigatran [rivaroksaban grubu], [dabigatran grubu]) uygulandı. Tedavi modalitelerinin etkinlikleri semptomatik veya Doppler USG ile tanısı koyulmuş derin ven trombozunu önlemeleri iken güvenlikleri profilaksi periodu sırasında görülen kanama sıklığı olarak belirlendi.

Bulgular: Altıncı haftada yapılan Doppler USG ile hiçbir hastada derin ven trombozuna rastlanmadı. Hastanede yatış süresince sadece iki majör kanamaya rastlandı (enoksaparin grubunda bir [%1.6), dabigatran grubunda bir [%1.6]). Taburculuk sonrası hiçbir hastada majör kanamaya rastlanmadı. Üç grup arasında kanama açısından istatistiksel anlamlı fark bulunamadı (p>0.05).

Çıkarımlar: Ardışık tedavi modaliteleri, hastanede yatış süresince enoksaparin uygulamasının güvenilirliğinden ve taburculuk sonrası yeni oral antikoagülanların kullanım kolaylığından faydalanılabilinir.

References

  • Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Port- man RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009;361:594–604.
  • Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban ver- sus enoxaparin for thromboprophylaxis after hip replace- ment. N Engl J Med 2010;363:2487–98.
  • Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physi- cians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):278–325.
  • Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost 2010;103:572–85.
  • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Oral dabigatran etexilate vs. subcu- taneous enoxaparin for the prevention of venous thrombo- embolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178–85.
  • Re-Mobilize Writing Committee, Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Ar- throplasty 2009;24:1–9.
  • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Dabigatran etexilate versus enoxa- parin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non- inferiority trial. Lancet 2007;370:949–56.
  • Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthro- plasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost 2011;105:721–9.
  • Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765–75.
  • Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, et al. Extended duration rivaroxaban versus short- term enoxaparin for the prevention of venous thromboem- bolism after total hip arthroplasty: a double-blind, ran- domised controlled trial. Lancet 2008;372:31–9.
  • Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RE- CORD4): a randomised trial Lancet 2009;373:1673–80.
  • Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ 2012;344:3675.
  • Nieto JA, Espada NG, Merino RG, González TC. Dabi- gatran, rivaroxaban and apixaban versus enoxaparin for thomboprophylaxis after total knee or hip arthroplasty: pool-analysis of phase III randomized clinical trials. Thromb Res 2012;130:183–91.
  • Lereun C, Wells P, Diamantopoulos A, Rasul F, Lees M, Sengupta N. An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement. J Med Econ 2011;14:238–44.
  • Lazo-Langner A, Fleet JL, McArthur E, Garg AX. Rivar- oxaban vs. low molecular weight heparin for the prevention of venous thromboembolism after hip or knee arthroplas- ty: a cohort study. J Thromb Haemost 2014;12:1626–35.
  • Levitan B, Yuan Z, Turpie AG, Friedman RJ, Homering M, Berlin JA, et al. Benefit-risk assessment of rivaroxaban versus enoxaparin for the prevention of venous thrombo- embolism after total hip or knee arthroplasty. Vasc Health Risk Manag 2014;10:157–67.
  • Altintaş F, Gürbüz H, Erdemli B, Atilla B, Ustaoğlu RG, Oziç U, et al. Venous thromboembolism prophylaxis in major orthopaedic surgery: A multicenter, prospective, ob- servational study. [Article in Turkish] Acta Orthop Trau- matol Turc 2008;42:322–7.

Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement

Year 2015, Volume: 49 Issue: 3, 255 - 259, 17.07.2015
https://doi.org/10.3944/AOTT.2015.14.0219

Abstract

Objective: Prevention of deep venous thrombosis (DVT) and associated pulmonary embolism following major orthopedic surgeries is challenging, and there is an increased interest in developing new treatment strategies. We compared 2 switch-therapy modalities—enoxaparin to rivaroxaban and enoxaparin to dabigatran—and enoxaparin monotherapy for preventing DVT after total knee arthroplasty (TKA) and total hip arthroplasty (THA).
Methods: This was a prospective, non-blinded, randomized controlled study. We selected 180 eligible patients out of 247 patients undergoing TKA or THA. During the preoperative checkup, patients were randomized to receive either enoxaparin (enoxaparin group) or switch-therapy regimens, comprising enoxaparin during hospitalization and rivaroxaban (rivaroxaban group) or dabigatran (dabigatran group) during the outpatient period. All patients were evaluated for DVT using Doppler ultrasonography (USG) 6 weeks postoperatively. The primary efficacy outcome was the prevention of symptomatic or Doppler ultrasonography (USG)-proven DVT, whereas the primary safety outcome was the incidence of bleeding during the DVT-prophylaxis period.
Results: Doppler USG at 6 weeks after surgery revealed no signs of DVT in any patient. During the hospitalization period, only 2 major bleeding events were reported (1 [1.6%] in the enoxaparin group and 1 [1.6%] in the dabigatran group). No major bleeding events were reported during the outpatient follow-up period in any group. Differences among the 3 groups regarding bleeding events were not statistically significant (p>0.05).
Conclusion: When using switch-therapy modalities, clinicians can take advantage of the safety of enoxaparin during the hospitalization period and ease of use of new oral anticoagulant drugs during the outpatient period.

References

  • Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Port- man RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009;361:594–604.
  • Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban ver- sus enoxaparin for thromboprophylaxis after hip replace- ment. N Engl J Med 2010;363:2487–98.
  • Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physi- cians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):278–325.
  • Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost 2010;103:572–85.
  • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Oral dabigatran etexilate vs. subcu- taneous enoxaparin for the prevention of venous thrombo- embolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178–85.
  • Re-Mobilize Writing Committee, Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Ar- throplasty 2009;24:1–9.
  • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al. Dabigatran etexilate versus enoxa- parin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non- inferiority trial. Lancet 2007;370:949–56.
  • Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthro- plasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost 2011;105:721–9.
  • Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765–75.
  • Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, et al. Extended duration rivaroxaban versus short- term enoxaparin for the prevention of venous thromboem- bolism after total hip arthroplasty: a double-blind, ran- domised controlled trial. Lancet 2008;372:31–9.
  • Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RE- CORD4): a randomised trial Lancet 2009;373:1673–80.
  • Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons. BMJ 2012;344:3675.
  • Nieto JA, Espada NG, Merino RG, González TC. Dabi- gatran, rivaroxaban and apixaban versus enoxaparin for thomboprophylaxis after total knee or hip arthroplasty: pool-analysis of phase III randomized clinical trials. Thromb Res 2012;130:183–91.
  • Lereun C, Wells P, Diamantopoulos A, Rasul F, Lees M, Sengupta N. An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement. J Med Econ 2011;14:238–44.
  • Lazo-Langner A, Fleet JL, McArthur E, Garg AX. Rivar- oxaban vs. low molecular weight heparin for the prevention of venous thromboembolism after hip or knee arthroplas- ty: a cohort study. J Thromb Haemost 2014;12:1626–35.
  • Levitan B, Yuan Z, Turpie AG, Friedman RJ, Homering M, Berlin JA, et al. Benefit-risk assessment of rivaroxaban versus enoxaparin for the prevention of venous thrombo- embolism after total hip or knee arthroplasty. Vasc Health Risk Manag 2014;10:157–67.
  • Altintaş F, Gürbüz H, Erdemli B, Atilla B, Ustaoğlu RG, Oziç U, et al. Venous thromboembolism prophylaxis in major orthopaedic surgery: A multicenter, prospective, ob- servational study. [Article in Turkish] Acta Orthop Trau- matol Turc 2008;42:322–7.
There are 17 citations in total.

Details

Primary Language English
Subjects Health Care Administration
Journal Section Original Article
Authors

Turhan Özler This is me

Çağatay Uluçay This is me

Ayberk Önal This is me

Faik Altıntaş This is me

Publication Date July 17, 2015
Published in Issue Year 2015 Volume: 49 Issue: 3

Cite

APA Özler, T., Uluçay, Ç., Önal, A., Altıntaş, F. (2015). Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement. Acta Orthopaedica Et Traumatologica Turcica, 49(3), 255-259. https://doi.org/10.3944/AOTT.2015.14.0219
AMA Özler T, Uluçay Ç, Önal A, Altıntaş F. Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement. Acta Orthopaedica et Traumatologica Turcica. July 2015;49(3):255-259. doi:10.3944/AOTT.2015.14.0219
Chicago Özler, Turhan, Çağatay Uluçay, Ayberk Önal, and Faik Altıntaş. “Comparison of Switch-Therapy Modalities (enoxaparin to rivaroxaban/Dabigatran) and Enoxaparin Monotherapy After Hip and Knee Replacement”. Acta Orthopaedica Et Traumatologica Turcica 49, no. 3 (July 2015): 255-59. https://doi.org/10.3944/AOTT.2015.14.0219.
EndNote Özler T, Uluçay Ç, Önal A, Altıntaş F (July 1, 2015) Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement. Acta Orthopaedica et Traumatologica Turcica 49 3 255–259.
IEEE T. Özler, Ç. Uluçay, A. Önal, and F. Altıntaş, “Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement”, Acta Orthopaedica et Traumatologica Turcica, vol. 49, no. 3, pp. 255–259, 2015, doi: 10.3944/AOTT.2015.14.0219.
ISNAD Özler, Turhan et al. “Comparison of Switch-Therapy Modalities (enoxaparin to rivaroxaban/Dabigatran) and Enoxaparin Monotherapy After Hip and Knee Replacement”. Acta Orthopaedica et Traumatologica Turcica 49/3 (July 2015), 255-259. https://doi.org/10.3944/AOTT.2015.14.0219.
JAMA Özler T, Uluçay Ç, Önal A, Altıntaş F. Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement. Acta Orthopaedica et Traumatologica Turcica. 2015;49:255–259.
MLA Özler, Turhan et al. “Comparison of Switch-Therapy Modalities (enoxaparin to rivaroxaban/Dabigatran) and Enoxaparin Monotherapy After Hip and Knee Replacement”. Acta Orthopaedica Et Traumatologica Turcica, vol. 49, no. 3, 2015, pp. 255-9, doi:10.3944/AOTT.2015.14.0219.
Vancouver Özler T, Uluçay Ç, Önal A, Altıntaş F. Comparison of switch-therapy modalities (enoxaparin to rivaroxaban/dabigatran) and enoxaparin monotherapy after hip and knee replacement. Acta Orthopaedica et Traumatologica Turcica. 2015;49(3):255-9.