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ETD3-2019

En personas de 65 años que son sometidas a una artroplastia total de cadera con endoprótesis y tienen un riesgo alto de enfermedad tromboembólica, el Ministerio de Salud SUGIERE profilaxis con anticoagulantes orales directos (rivaroxaban, dabigatran o apixaban) por sobre usar profilaxis con heparinas de bajo peso molecular.

Comentarios del panel:
– El antecedente de un evento previo o una limitada movilidad post-cirugía confieren un riesgo alto de presentar un evento tromboembólico. Personas con estas condiciones son los que probablemente más se benefician del uso de anticoagulantes.
– Si bien los anticoagulantes orales pueden ser iniciados al día siguiente de la cirugía, habitualmente no están disponibles en los centros de salud, por lo que es razonable iniciar la profilaxis con heparina e indicar los anticoagulantes orales al momento del alta.

El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.

A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.

 1.- ¿El problema es una prioridad?
No Probablemente no Probablemente sí Varía No lo sé

El problema o condición de salud abordado en la pregunta ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad. Además, particularmente, la pregunta ¿En personas de 65 años y más con endoprótesis total de cadera al momento del alta se debe “usar tromboprofilaxis con HBPM” en comparación a “usar anticoagulantes orales directos (rivaroxaban, dabigatran o apixaban)?» fue priorizada por un panel de expertos en la materia. Ver detalle en Informe de Priorización de Preguntas de Práctica Clínica.

 2.- ¿Qué tan significativos son los efectos deseables anticipados?
Trivial Pequeño Moderado Grande Varía No lo sé

Triviales: Tomando en cuenta la evidencia identificada, la experiencia clínica y de las personas con el problema de salud, el equipo elaborador de la guía estimó que la magnitud de los efectos deseables de “usar tromboprofilaxis con HBPM» en comparación a “usar anticoagulantes orales directos (rivaroxaban o dabigatran o apixaban)» son triviales o no relevantes para las personas.

Evidencia de investigación

TROMBOPROFILAXIS CON HBPM EN PERSONAS CON ENDOPRÓTESIS DE CADERA HOSPITALIZADOS.
Pacientes Personas con endoprótesis total de cadera hospitalizados.
Intervención Usar anticoagulantes orales directos (ACOD) (rivaroxaban, dabigatran o apixaban).
Comparación Usar tromboprofilaxis con HBPM

Desenlaces

Efecto relativo

(IC 95%)

Pacientes/ estudios

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

CON
 HBPM

CON
 ACOD

Diferencia

(IC 95%)

Mortalidad

RR 0,94

(0,53 a 1,66)

41.816 pacientes/ 

37 ensayos 

1

por 1000

1

por 1000

0 más 

(1 menos a 1 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia la mortalidad 

Tromboembolismo pulmonar

 

RR 0,74

(0,50 a 1,10)

41.634 pacientes/ 

37 ensayos 

3

por 1000

3

por 1000

1 menos 

(1 menos a 0 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia el riesgo de tromboembolismo pulmonar

Trombosis 

venosa  profunda

 

RR 0,56

(0,39 a 0,79)

39.994 pacientes/ 

37 ensayos 

6

por 1000

3

por 1000

3 menos 

(4 a 1 menos) 

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM reduce el riesgo de trombosis venosa profunda

Evento de sangrado mayor

RR 1,03

(0,79 a 1,35)

46.382  pacientes/ 

37 ensayos 

8

por 1000

8

por 1000

0 menos 

(2 menos a 3 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia el riesgo de sangrado mayor

 

Adherencia 

al tratamiento

 

No fue medido en los estudios.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
Fecha de elaboración de la tabla: Noviembre, 2019.

Referencias

1. AlHajri L, Jabbari S, AlEmad H, AlMahri K, AlMahri M, AlKitbi N. The Efficacy and Safety of Edoxaban for VTE Prophylaxis Post-Orthopedic Surgery: A Systematic Review. Journal of cardiovascular pharmacology and therapeutics. 2017;22(3):230-238.
2. Alves C, Batel-Marques F, Macedo AF. Apixaban and rivaroxaban safety after hip and knee arthroplasty: a meta-analysis. Journal of cardiovascular pharmacology and therapeutics. 2012;17(3):266-276.
3. Aristizabal H, Montoya L, Donado G. Rivaroxaban versus low weight heparins for venous thromboembolism prophylaxis after major hip and knee arthroplasty: systematic review and metaanalysis. Iatreia. 2013;26(2):136-152.
4. Balk EM, Ellis AG, Di M, Adam GP, Trikalinos TA. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update. 2017.
5. Boyd R, Dicarlo L, Mandema J. Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose-Response Meta-analysis. Clinical and Translational Science. 2017;10(4):260-270.
6. Caldeira D, Rodrigues FB, Pinto FJ, Ferreira JJ, Costa J. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis. Clinical medicine insights Blood disorders. 2017;10(10):1179545X17704660.
7. Cao YB, Zhang JD, Shen H, Jiang YY. Rivaroxaban versus enoxaparin for thromboprophylaxis after total hip or knee arthroplasty: a meta-analysis of randomized controlled trials. European journal of clinical pharmacology. 2010;66(11):1099-1108.
8. Chan NC, Siegal D, Lauw MN, et al. A systematic review of contemporary trials of anticoagulants in orthopaedic thromboprophylaxis: suggestions for a radical reappraisal. Journal of thrombosis and thrombolysis. 2015;40((Chan N.C., noel.chan@phri.ca; Lauw M.N., Mandy.Lauw@phri.ca; Ginsberg J.S., ginsbrgj@mcmaster.ca; Eikelboom J.W., eikelbj@mcmaster.ca; Hirsh J., hirshj@mcmaster.ca) Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada):231-239.
9. Feng W, Wu K, Liu Z, et al. Oral direct factor Xa inhibitor versus enoxaparin for thromboprophylaxis after hip or knee arthroplasty: Systemic review, traditional meta-analysis, dose-response meta-analysis and network meta-analysis. Thrombosis research. 2015;136(6):1133-1144.
10. Forster R, Stewart M. Anticoagulants (extended duration) for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair. Cochrane Database of Systematic Reviews. 2016;3:CD004179.
11. 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 (Clinical research ed). 2012;344:e3675.
12. Harenberg J, Marx S, Dahl OE, et al. Interpretation of endpoints in a network meta-analysis of new oral anticoagulants following total hip or total knee replacement surgery. Thrombosis and haemostasis. 2012;108(5):903-912.
13. Januel JM, Chen G, Ruffieux C, et al. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA : the journal of the American Medical Association. 2012;307(3):294-303.
14. Kapoor A, Ellis A, Shaffer N, et al. Comparative effectiveness of venous thromboembolism prophylaxis options for the patient undergoing total hip and knee replacement: a network meta-analysis. Journal of Thrombosis and Haemostasis. 2017;15(2):284-294.
15. Lewis S, Glen J, Dawoud D, et al. Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip Replacement: A Systematic Review and Network Meta-Analysis. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2019;22(8):953-969.
16. Li XM, Sun SG, Zhang WD. Apixaban versus enoxaparin for thromboprophylaxis after total hip or knee arthroplasty: a meta-analysis of randomized controlled trials. Chinese medical journal. 2012;125(13):2339-2345.
17. Lieberman JR, Cheng V, Cote MP. Pulmonary Embolism Rates Following Total Hip Arthroplasty With Prophylactic Anticoagulation: Some Pulmonary Emboli Cannot Be Avoided. The Journal of arthroplasty. 2017;32(3):980-986.
18. Loke YK, Kwok CS. Dabigatran and rivaroxaban for prevention of venous thromboembolism–systematic review and adjusted indirect comparison. Journal of clinical pharmacy and therapeutics. 2011;36(1):111-124.
19. Lu X, Lin J. Low molecular weight heparin versus other anti-thrombotic agents for prevention of venous thromboembolic events after total hip or total knee replacement surgery: a systematic review and meta-analysis. BMC musculoskeletal disorders. 2018;19(1):322.
20. Melillo SN, Scanlon JV, Exter BP, Steinberg M, Jarvis CI. Rivaroxaban for thromboprophylaxis in patients undergoing major orthopedic surgery. The Annals of pharmacotherapy. 2010;44(6):1061-1071.
21. Ndegwa S, Moulton K, Argaez C. Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety. 2010-09-08 2009.
22. Neumann I, Rada G, Claro JC, et al. Oral Direct Factor Xa Inhibitors Versus Low-Molecular-Weight Heparin to Prevent Venous Thromboembolism in Patients Undergoing Total Hip or Knee Replacement: A Systematic Review and Meta-analysis. Annals of internal medicine. 2012;156(10):710-719.
23. Pathak R, Giri S, Karmacharya P, et al. Meta-analysis on efficacy and safety of new oral anticoagulants for venous thromboembolism prophylaxis in elderly elective postarthroplasty patients. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2015;26(8):934-939.
24. Pathak R, Karmacharya P, Giri S, et al. Meta-analysis on efficacy and safety of new oral anticoagulants for venous thromboembolism prophylaxis in overweight and obese postarthroplasty patients. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2015;26(6):635-642.
25. Perez A, Eraso LH, Merli GJ. Implications of new anticoagulants in primary practice. International journal of clinical practice. 2013;67(2):139-156.
26. Poultsides LA, Gonzalez Della Valle A, Memtsoudis SG, et al. Meta-analysis of cause of death following total joint replacement using different thromboprophylaxis regimens. The Journal of bone and joint surgery British volume. 2012;94(1):113-121.
27. Prom R, Spinler SA. The role of apixaban for venous and arterial thromboembolic disease. The Annals of pharmacotherapy. 2011;45(10):1262-1283.
28. Ringerike T, Hamidi V, Hagen G, Reikvam Å, Klemp M. Thromboprophylactic treatment with rivaroxaban or dabigatran compared with enoxaparin or dalteparin in patients undergoing elective hip- or knee replacement surgery. 2011 2011.
29. Riva N, Dentali F, Permunian ET, Ageno W. Major Bleeding and Case Fatality Rate with the Direct Oral Anticoagulants in Orthopedic Surgery: A Systematic Review and Meta-Analysis. Seminars in thrombosis and hemostasis. 2016;42(1):42-54.
30. Russell RD, Huo MH. Apixaban and rivaroxaban decrease deep venous thrombosis but not other complications after total hip and total knee arthroplasty. The Journal of arthroplasty. 2013;28(9):1477-1481.
31. Salazar CA, Malaga G, Malasquez G. Direct thrombin inhibitors versus vitamin K antagonists or low molecular weight heparins for prevention of venous thromboembolism following total hip or knee replacement. Cochrane database of systematic reviews (Online). 2010(4):CD005981.
32. Sobieraj DM, Coleman CI, Tongbram V, et al. Comparative effectiveness of low-molecular-weight heparins versus other anticoagulants in major orthopedic surgery: a systematic review and meta-analysis. Pharmacotherapy. 2012;32(9):799-808.
33. Squizzato A, Lussana F, Cattaneo M. Post-operative arterial thrombosis with non-vitamin K antagonist oral anticoagulants after total hip or knee arthroplasty. Thrombosis and haemostasis. 2015;114(2):237-244.
34. Suen K, Westh RN, Churilov L, Hardidge AJ. Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty. Journal of Arthroplasty. 2017;32(9):2911-2919.e2916.
35. Sun G, Wu J, Wang Q, et al. Factor Xa Inhibitors and Direct Thrombin Inhibitors Versus Low-Molecular-Weight Heparin for Thromboprophylaxis After Total Hip or Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. The Journal of arthroplasty. 2019;34(4):789-800.e786.
36. Tahir F, Riaz H, Riaz T, et al. The new oral anti-coagulants and the phase 3 clinical trials – a systematic review of the literature. Thrombosis journal. 2013;11(1):18.
37. Turun S, Banghua L, Yuan Y, Zhenhui L, Ying N, Jin C. A systematic review of rivaroxaban versus enoxaparin in the prevention of venous thromboembolism after hip or knee replacement. Thrombosis research. 2011;127(6):525-534.
38. Wang Z, Zhao L, Liu S, Li C, Zhang P, Yu C. Efficacy and safety of oral direct factor Xa inhibitor for thromboprophylaxis after total hip or knee replacement: A meta-analysis. International Journal of Clinical and Experimental Medicine. 2016;9(6):10695-10705.
39. Yang C, Miao XG, Yuan H. Rivaroxaban versus enoxaparin for prevention of deep venous thrombosis after major orthopedic operation: A systematic review. Chinese Journal of Evidence-Based Medicine. 2011;11(8):940-945.
40. Yoshida Rde A, Yoshida WB, Maffei FH, El Dib R, Nunes R, Rollo HA. Systematic review of randomized controlled trials of new anticoagulants for venous thromboembolism prophylaxis in major orthopedic surgeries, compared with enoxaparin. Annals of vascular surgery. 2013;27(3):355-369.
41. Agnelli G, Haas S, Ginsberg JS, Krueger KA, Dmitrienko A, Brandt JT. A phase II study of the oral factor Xa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement. Journal of thrombosis and haemostasis : JTH. 2007;5(4):746-753.
42. Chen D XY, Jia S. Efficacy and safety of rivaroxaban in preventing deep venous thromboembolism after major orthopedic operations. Int J Clin Exp Med. 2016;9(2):4077-4082.
43. Cohen AT, Boyd RA, Mandema JW, Dicarlo L, Pak R. An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery. Journal of thrombosis and haemostasis : JTH. 2013;11(8):1503-1510.
44. Eriksson BI, Agnelli G, Gallus AS, et al. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thrombosis and haemostasis. 2014;111(2):213-225.
45. Eriksson BI, Borris L, Dahl OE, et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. Journal of thrombosis and haemostasis : JTH. 2006;4(1):121-128.
46. Eriksson BI, Borris LC, Dahl OE, et al. Dose-escalation study of rivaroxaban (BAY 59-7939)–an oral, direct Factor Xa inhibitor–for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thrombosis research. 2007;120(5):685-693.
47. Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation. 2006;114(22):2374-2381.
48. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. The New England journal of medicine. 2008;358(26):2765-2775.
49. Eriksson BI, Dahl OE, Huo MH, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thrombosis and haemostasis. 2011;105(4):721-729.
50. 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. Journal of thrombosis and haemostasis : JTH. 2007;5(11):2178-2185.
51. 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 (London, England). 2007;370(9591):949-956.
52. Eriksson BI, Turpie AG, Lassen MR, et al. A dose escalation study of YM150, an oral direct factor Xa inhibitor, in the prevention of venous thromboembolism in elective primary hip replacement surgery. Journal of thrombosis and haemostasis : JTH. 2007;5(8):1660-1665.
53. Eriksson BI, Turpie AG, Lassen MR, et al. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). Journal of thrombosis and haemostasis : JTH. 2010;8(4):714-721.
54. Fuji T, Fujita S, Kawai Y, et al. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V. Thrombosis journal. 2015;13:27.
55. Fuji T, Fujita S, Kawai Y, et al. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thrombosis research. 2014;133(6):1016-1022.
56. Fuji T, Nakamura M, Takeuchi M. Darexaban for the prevention of venous thromboembolism in Asian patients undergoing orthopedic surgery: results from 2 randomized, placebo-controlled, double-blind studies. Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2014;20(2):199-211.
57. Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. The Journal of arthroplasty. 2014;29(12):2439-2446.
58. Fuji T, Wang CJ, Fujita S, et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thrombosis research. 2014;134(6):1198-1204.
59. 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. The Journal of arthroplasty. 2009;24(1):1-9.
60. Hui Z DW, Hai-yu S, Shu-wei L, Liang L. Efficacy and safety of rivaroxaban in the prevention of deep vein thrombosis after hip arthroplasty. Chinese Journal of Tissue Engineering Research. 2013;17(30):5440-5445.
61. 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 (London, England). 2008;372(9632):31-39.
62. Kim SM, Moon YW, Lim SJ, Kim DW, Park YS. Effect of oral factor Xa inhibitor and low-molecular-weight heparin on surgical complications following total hip arthroplasty. Thrombosis and haemostasis. 2016;115(3):600-607.
63. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. The New England journal of medicine. 2008;358(26):2776-2786.
64. Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. Journal of thrombosis and haemostasis : JTH. 2007;5(12):2368-2375.
65. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. The New England journal of medicine. 2010;363(26):2487-2498.
66. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet (London, England). 2010;375(9717):807-815.
67. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. The New England journal of medicine. 2009;361(6):594-604.
68. Mirdamadi A, Dashtkar S, Kaji M, Pazhang F, Haghpanah B, Gharipour M. Dabigatran versus Enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: A randomized clinical trial. ARYA atherosclerosis. 2014;10(6):292-297.
69. Raskob G, Cohen AT, Eriksson BI, et al. Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study. Thrombosis and haemostasis. 2010;104(3):642-649.
70. Silva-Kanan P SC, Carbonera L, Conrad S, Faria M. Comparative study between rivaroxaban and enoxaparinnin deep venous thromboembolism prophylaxis innpatients submitted to total hip arthroplasty. Rev Bras Ortop. 2008;43(8):319-328.
71. Singh SK KA. The prevent trial – prevention of venous thromboembolism with enoxaparin vs rivaroxaban following hip and knee replacement surgeries. Internal Medicine Journal. 2012;42(Suppl. 2):14-22.
72. Turpie AG, Bauer KA, Davidson BL, et al. A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT). Thrombosis and haemostasis. 2009;101(1):68-76.
73. Turpie AG, Fisher WD, Bauer KA, et al. BAY 59-7939: an oral, direct factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. Journal of thrombosis and haemostasis : JTH. 2005;3(11):2479-2486.
74. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet (London, England). 2009;373(9676):1673-1680.
75. Weitz JI, Cao C, Eriksson BI, et al. A dose-finding study with TAK-442, an oral factor Xa inhibitor, in patients undergoing elective total knee replacement surgery. Thrombosis and haemostasis. 2010;104(6):1150-1157.
76. Yong H DP, Yi S, Xia C. Different anticoagulant drugs during knee joint replacement: changes of hemorheology. Chinese Journal of Tissue Engineering Research. 2015;19(13):2023-2027.
77. Zou Y, Tian S, Wang Y, Sun K. Administering aspirin, rivaroxaban and low-molecular-weight heparin to prevent deep venous thrombosis after total knee arthroplasty. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2014;25(7):660-664.

Búsqueda y Síntesis de Evidencia

 3.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grande Moderado Pequeño Trivial Varía No lo sé

Triviales: Tomando en cuenta la evidencia identificada, la experiencia clínica y de las personas con el problema de salud, el equipo elaborador de la guía estimó que la magnitud de los efectos indeseables de «Realizar valoración geriátrica integral pre quirúrgica (considerar 1 hora al menos, y debe ser un profesional de la salud con formación en el área de geriatría o gerontología)» en comparación a » No realizar valoración geriátrica integral» son triviales o probablemente no es relevantes para las personas.

Evidencia de investigación

TROMBOPROFILAXIS CON HBPM EN PERSONAS CON ENDOPRÓTESIS DE CADERA HOSPITALIZADOS.
Pacientes Personas con endoprótesis total de cadera hospitalizados.
Intervención Usar anticoagulantes orales directos (ACOD) (rivaroxaban, dabigatran o apixaban).
Comparación Usar tromboprofilaxis con HBPM

Desenlaces

Efecto relativo

(IC 95%)

Pacientes/ estudios

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

CON
 HBPM

CON
 ACOD

Diferencia

(IC 95%)

Mortalidad

RR 0,94

(0,53 a 1,66)

41.816 pacientes/ 

37 ensayos 

1

por 1000

1

por 1000

0 más 

(1 menos a 1 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia la mortalidad 

Tromboembolismo pulmonar

 

RR 0,74

(0,50 a 1,10)

41.634 pacientes/ 

37 ensayos 

3

por 1000

3

por 1000

1 menos 

(1 menos a 0 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia el riesgo de tromboembolismo pulmonar

Trombosis 

venosa  profunda

 

RR 0,56

(0,39 a 0,79)

39.994 pacientes/ 

37 ensayos 

6

por 1000

3

por 1000

3 menos 

(4 a 1 menos) 

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM reduce el riesgo de trombosis venosa profunda

Evento de sangrado mayor

RR 1,03

(0,79 a 1,35)

46.382  pacientes/ 

37 ensayos 

8

por 1000

8

por 1000

0 menos 

(2 menos a 3 más)

⊕⊕⊕⊕

Alta

En personas sometidas a una artroplastia total de cadera con endoprotesis, usar ACOD en comparación a HBPM no cambia el riesgo de sangrado mayor

 

Adherencia 

al tratamiento

 

No fue medido en los estudios.

IC 95%: Intervalo de confianza del 95%.
RR: Riesgo relativo.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
Fecha de elaboración de la tabla: Noviembre, 2019.

Referencias

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29. Riva N, Dentali F, Permunian ET, Ageno W. Major Bleeding and Case Fatality Rate with the Direct Oral Anticoagulants in Orthopedic Surgery: A Systematic Review and Meta-Analysis. Seminars in thrombosis and hemostasis. 2016;42(1):42-54.
30. Russell RD, Huo MH. Apixaban and rivaroxaban decrease deep venous thrombosis but not other complications after total hip and total knee arthroplasty. The Journal of arthroplasty. 2013;28(9):1477-1481.
31. Salazar CA, Malaga G, Malasquez G. Direct thrombin inhibitors versus vitamin K antagonists or low molecular weight heparins for prevention of venous thromboembolism following total hip or knee replacement. Cochrane database of systematic reviews (Online). 2010(4):CD005981.
32. Sobieraj DM, Coleman CI, Tongbram V, et al. Comparative effectiveness of low-molecular-weight heparins versus other anticoagulants in major orthopedic surgery: a systematic review and meta-analysis. Pharmacotherapy. 2012;32(9):799-808.
33. Squizzato A, Lussana F, Cattaneo M. Post-operative arterial thrombosis with non-vitamin K antagonist oral anticoagulants after total hip or knee arthroplasty. Thrombosis and haemostasis. 2015;114(2):237-244.
34. Suen K, Westh RN, Churilov L, Hardidge AJ. Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty. Journal of Arthroplasty. 2017;32(9):2911-2919.e2916.
35. Sun G, Wu J, Wang Q, et al. Factor Xa Inhibitors and Direct Thrombin Inhibitors Versus Low-Molecular-Weight Heparin for Thromboprophylaxis After Total Hip or Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. The Journal of arthroplasty. 2019;34(4):789-800.e786.
36. Tahir F, Riaz H, Riaz T, et al. The new oral anti-coagulants and the phase 3 clinical trials – a systematic review of the literature. Thrombosis journal. 2013;11(1):18.
37. Turun S, Banghua L, Yuan Y, Zhenhui L, Ying N, Jin C. A systematic review of rivaroxaban versus enoxaparin in the prevention of venous thromboembolism after hip or knee replacement. Thrombosis research. 2011;127(6):525-534.
38. Wang Z, Zhao L, Liu S, Li C, Zhang P, Yu C. Efficacy and safety of oral direct factor Xa inhibitor for thromboprophylaxis after total hip or knee replacement: A meta-analysis. International Journal of Clinical and Experimental Medicine. 2016;9(6):10695-10705.
39. Yang C, Miao XG, Yuan H. Rivaroxaban versus enoxaparin for prevention of deep venous thrombosis after major orthopedic operation: A systematic review. Chinese Journal of Evidence-Based Medicine. 2011;11(8):940-945.
40. Yoshida Rde A, Yoshida WB, Maffei FH, El Dib R, Nunes R, Rollo HA. Systematic review of randomized controlled trials of new anticoagulants for venous thromboembolism prophylaxis in major orthopedic surgeries, compared with enoxaparin. Annals of vascular surgery. 2013;27(3):355-369.
41. Agnelli G, Haas S, Ginsberg JS, Krueger KA, Dmitrienko A, Brandt JT. A phase II study of the oral factor Xa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement. Journal of thrombosis and haemostasis : JTH. 2007;5(4):746-753.
42. Chen D XY, Jia S. Efficacy and safety of rivaroxaban in preventing deep venous thromboembolism after major orthopedic operations. Int J Clin Exp Med. 2016;9(2):4077-4082.
43. Cohen AT, Boyd RA, Mandema JW, Dicarlo L, Pak R. An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery. Journal of thrombosis and haemostasis : JTH. 2013;11(8):1503-1510.
44. Eriksson BI, Agnelli G, Gallus AS, et al. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thrombosis and haemostasis. 2014;111(2):213-225.
45. Eriksson BI, Borris L, Dahl OE, et al. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. Journal of thrombosis and haemostasis : JTH. 2006;4(1):121-128.
46. Eriksson BI, Borris LC, Dahl OE, et al. Dose-escalation study of rivaroxaban (BAY 59-7939)–an oral, direct Factor Xa inhibitor–for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thrombosis research. 2007;120(5):685-693.
47. Eriksson BI, Borris LC, Dahl OE, et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation. 2006;114(22):2374-2381.
48. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. The New England journal of medicine. 2008;358(26):2765-2775.
49. Eriksson BI, Dahl OE, Huo MH, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thrombosis and haemostasis. 2011;105(4):721-729.
50. 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. Journal of thrombosis and haemostasis : JTH. 2007;5(11):2178-2185.
51. 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 (London, England). 2007;370(9591):949-956.
52. Eriksson BI, Turpie AG, Lassen MR, et al. A dose escalation study of YM150, an oral direct factor Xa inhibitor, in the prevention of venous thromboembolism in elective primary hip replacement surgery. Journal of thrombosis and haemostasis : JTH. 2007;5(8):1660-1665.
53. Eriksson BI, Turpie AG, Lassen MR, et al. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). Journal of thrombosis and haemostasis : JTH. 2010;8(4):714-721.
54. Fuji T, Fujita S, Kawai Y, et al. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V. Thrombosis journal. 2015;13:27.
55. Fuji T, Fujita S, Kawai Y, et al. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thrombosis research. 2014;133(6):1016-1022.
56. Fuji T, Nakamura M, Takeuchi M. Darexaban for the prevention of venous thromboembolism in Asian patients undergoing orthopedic surgery: results from 2 randomized, placebo-controlled, double-blind studies. Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2014;20(2):199-211.
57. Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. The Journal of arthroplasty. 2014;29(12):2439-2446.
58. Fuji T, Wang CJ, Fujita S, et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thrombosis research. 2014;134(6):1198-1204.
59. 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. The Journal of arthroplasty. 2009;24(1):1-9.
60. Hui Z DW, Hai-yu S, Shu-wei L, Liang L. Efficacy and safety of rivaroxaban in the prevention of deep vein thrombosis after hip arthroplasty. Chinese Journal of Tissue Engineering Research. 2013;17(30):5440-5445.
61. 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 (London, England). 2008;372(9632):31-39.
62. Kim SM, Moon YW, Lim SJ, Kim DW, Park YS. Effect of oral factor Xa inhibitor and low-molecular-weight heparin on surgical complications following total hip arthroplasty. Thrombosis and haemostasis. 2016;115(3):600-607.
63. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. The New England journal of medicine. 2008;358(26):2776-2786.
64. Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. Journal of thrombosis and haemostasis : JTH. 2007;5(12):2368-2375.
65. Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. The New England journal of medicine. 2010;363(26):2487-2498.
66. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet (London, England). 2010;375(9717):807-815.
67. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. The New England journal of medicine. 2009;361(6):594-604.
68. Mirdamadi A, Dashtkar S, Kaji M, Pazhang F, Haghpanah B, Gharipour M. Dabigatran versus Enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: A randomized clinical trial. ARYA atherosclerosis. 2014;10(6):292-297.
69. Raskob G, Cohen AT, Eriksson BI, et al. Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study. Thrombosis and haemostasis. 2010;104(3):642-649.
70. Silva-Kanan P SC, Carbonera L, Conrad S, Faria M. Comparative study between rivaroxaban and enoxaparinnin deep venous thromboembolism prophylaxis innpatients submitted to total hip arthroplasty. Rev Bras Ortop. 2008;43(8):319-328.
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Búsqueda y Síntesis de Evidencia

 4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
Muy baja Baja Moderada Alta Ningún estudio incluido

Alta: Existe una alta confianza de que la evidencia identificada es apropiada para formular una recomendación.

Evidencia de investigación

Desenlaces

Importancia

Certeza de la evidencia
 (GRADE)

Mortalidad

CRÍTICO

⨁⨁⨁⨁
 ALTA

Tromboembolismo pulmonar

CRÍTICO

⨁⨁⨁⨁
 ALTA

Trombosis 

venosa profunda

CRÍTICO

⨁⨁⨁⨁
 ALTA

Evento de sangrado mayor

CRÍTICO

⨁⨁⨁⨁
 ALTA

Adherencia al tratamiento – no reportado

CRÍTICO

 5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
Variabilidad importantes Posiblemente hay incertidumbre o variabilidad importantes Probablemente no hay incertidumbre ni variabilidad importantes No hay variabilidad o incertidumbre importante

Probablemente no hay variabilidad importante: Tomando en cuenta la evidencia identificada, la experiencia clínica y la vivencia de las personas con el problema de salud, el equipo elaborador de la guía consideró que probablemente no existe variabilidad en como las personas, correctamente informadas, podrían valorar los efectos deseables e indeseables de “usar tromboprofilaxis con HBPM».

Consideraciones Adicionales

La forma de administración de la heparina de bajo peso molecular condicionaría la variabilidad.

Evidencia de investigación

No se identificaron estudios que respondan la pregunta de manera directa ni indirecta para todas las estrategias de búsqueda realizadas.

Búsqueda y Síntesis de Evidencia

 6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía No lo sé

Probablemente favorece la comparación: Tomando en cuenta la magnitud de los efectos deseables e indeseables, así como los valores y preferencias de las personas, el equipo elaborador de la guía consideró que “usar anticoagulantes orales directos (rivaroxaban o dabigatran o apixaban)» probablemente es la mejor alternativa en la mayoría de las situaciones, aunque pudieran haber escenarios donde se justifique “usar tromboprofilaxis con HBPM».

Consideraciones Adicionales

El panel considera que las molestias de la administración de heparina de bajo peso molecular (HBPM) favorecen el uso de anticoagulantes orales directos (ACOD).

 7.- ¿Qué tan grandes son los recursos necesarios (costos)?
Costos extensos Costos moderados Costos y ahorros pequeños Ahorros moderados Ahorros extensos Varía No lo sé

Costos y ahorros pequeños: La diferencia del costo o ahorros entre » Usar tromboprofilaxis con HBPM» y » Usar anticoagulantes orales directos (rivaroxaban o dabigatran o apixaban)» es inferior a $674.672. Por lo cual el equipo elaborador de la guía consideró que implementar »Usar tromboprofilaxis con HBPM» no significaría un cambio importante en el gasto o ahorro del sistema de salud.

Evidencia de investigación

Tabla N° 1 Precios referenciales

Ítem

Intervención

Comparador

HBPM (mensual)

$ 93.463

Dabigatran (150 mg) (mensual)

$18.930

Rivaroxaban (10 mg) (mensual)

$69.437

 Total

$ 93.463

$18.930 – $69.437

*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación (es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
Fuente:
1 Mercado Público

Búsqueda y Síntesis de Evidencia

 8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía Ningún estudio incluido

Ningún estudio incluido: No se identificaron estudios evaluando costo-efectividad.

Evidencia de investigación

Para determinar si la evidencia de costo-efectividad de las tecnologías sanitarias era necesaria se aplicaron los siguientes criterios en conjunto con el equipo de expertos:
– Mucha variabilidad en la práctica clínica.
– Incertidumbre relevante respecto a costo efectividad de intervenciones evaluadas.
– Cambio en práctica clínica acarrea altos beneficios en términos de salud.
– El cambio en la práctica clínica puede tener un impacto relevante en costos y el presupuesto del sistema de salud.

Considerando lo anterior más el resultado de la búsqueda de efectividad, que no indica superioridad de una opción clínica sobre la otra, no se realizó búsqueda de costo efectividad para esta pregunta.

Búsqueda y Síntesis de Evidencia

 9.- ¿Cuál sería el impacto en equidad en salud?
Reducido Probablemente reducido Probablemente ningún impacto Probablemente aumentado Aumentado Varía No lo sé

Probablemente ningún impacto: El equipo elaborador de la guía consideró que esta recomendación probablemente no tendría ningún impacto en la equidad en salud, dado que que en la actualidad existe amplio acceso a ambas alternativas, ya sea en términos económicos, geográficos u otros.

 10.- ¿La intervención es aceptable para las partes interesadas?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente no: El equipo elaborador de la guía consideró que »usar tromboprofilaxis con HBPM» probablemente NO es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).

Consideraciones Adicionales

Las barreras de aceptabilidad son la vía de administración. Hay costos indirectos relacionados a la administración de HBMP.

 11.- ¿Es factible implementar la intervención?
No Probablemente no Probablemente sí Varía No lo sé

Sí: Tomando en cuenta la capacidad de la red asistencial y los recursos humanos y materiales disponibles, el equipo elaborador de la guía consideró que SI es factible implementar »usar tromboprofilaxis con HBPM» .

Consideraciones Adicionales

La intervención HBMP ya se realiza.