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Balk EM, Ellis AG, Di M, et al. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Jun. (Comparative Effectiveness Reviews, No. 191.)

Cover of Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update

Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update [Internet].

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Appendix FStudy Results

Table F1. RCT total hip replacement.

Table F1

RCT total hip replacement.

Table F2. RCT total knee replacement.

Table F2

RCT total knee replacement.

Table F3RCT hip fracture surgery

StudyArmTimepointn/N (%)
Bleeding, Fatal
Eriksson 2001 11794148Fondaparinux (FXaI)11 days0/831 (0%)
Enoxaparin (LMWH)1/842 (0.1%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days8/329 (2.4%)
Fondaparinux 25–31 days (NA)6/327 (1.8%)
Jørgensen 1992 1314147Placebo (Placebo)Post-operative days0/38 (0%)
Dalteparin (LMWH)0/30 (0%)
Lassen 2012 22429800 HFxSemuloparin (NA)period from the first injection given during the study up to the last injection plus 3 calendar0/488 (0%)
Enoxaparin (NA)0/499 (0%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days0/46 (0%)
Heparin (UFH)1/44 (2.3%)
Powers 1989 2650646Placebo (Placebo)21 days0/63 (0%)
Aspirin (Antiplatelet)0/66 (0%)
Warfarin (VKA)0/65 (0%)
Sasaki 2011 21293896Placebo (Placebo)14 days0/29 (0%)
-Fondaparinux (FXaI)0/27 (0%)
Enoxaparin (LMWH)0/28 (0%)
Bleeding, Leading to infection
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days0/329 (0%)
Fondaparinux 25–31 days (NA)0/327 (0%)
Bleeding, Leading to reoperation
Eriksson 2001 11794148Fondaparinux (FXaI)11 days3/831 (0.4%)
Enoxaparin (LMWH)2/842 (0.2%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days2/329 (0.6%)
Fondaparinux 25–31 days (NA)2/327 (0.6%)
Bleeding, Major
Eriksson 2001 11794148Fondaparinux (FXaI)11 days18/831 (2.2%)
Enoxaparin (LMWH)19/842 (2.3%)
Fondaparinux 6–8 days (NA)32 days2/329 (0.6%)
Fondaparinux 25–31 days (NA)8/327 (2.4%)
Fisher 2013 23539696Semuloparin 28 days (NA)28 days1/312 (0.3%)
Semuloparin 8 days (NA)0/157 (0%)
Fuji 2014B 24680549Edoxaban (FXaI)25–35 days1/59 (1.7%)
Enoxaparin (LMWH)1/29 (3.4%)
Lassen 2012 22429800 HFxSemuloparin (NA)period from the first injection given during the study up to the last injection plus 3 calendar days days days5/488 (1.0%)
Enoxaparin (NA)3/499 (0.6%)
Powers 1989 2650646Placebo (Placebo)21 days5/63 (7.9%)
Aspirin (Antiplatelet)1/66 (1.5%)
Warfarin (VKA)5/65 (7.7%)
Sasaki 2011 21293896Placebo (Placebo)14 days0/29 (0%)
Fondaparinux (FXaI)2/27 (7.4%)
Enoxaparin (LMWH)0/28 (0%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days1/66 (1.5%)
Enoxaparin (NA)2/66 (3.0%)
Bleeding, Surgical site/joint
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days0/329 (0%)
-Fondaparinux 25–31 days (NA)6/327 (1.8%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days1/66 (1.5%)
Enoxaparin (NA)0/66 (0%)
DVT, Proximal
Eriksson 2001 11794148Fondaparinux (FXaI)11 days6/650 (0.9%)
Enoxaparin (LMWH)28/646 (4.3%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days35/222 (16%)
Fondaparinux 25–31 days (NA)2/221 (0.9%)
Fisher 2013 23539696Semuloparin 28 days (NA)28 days4/267 (1.5%)
Semuloparin 8 days (NA)11/127 (8.7%)
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days0/46 (0%)
--Enoxaparin (LMWH)0/27 (0%)
Lassen 2012 22429800 HFxSemuloparin (NA)7–11 days13/426 (3.1%)
Enoxaparin (NA)26/420 (6.2%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days12/32 (38%)
Heparin (UFH)5/30 (17%)
Sasaki 2011 21293896Placebo (Placebo)14 days4/29 (14%)
Fondaparinux (FXaI)1/27 (3.7%)
Enoxaparin (LMWH)2/28 (7.1%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days3/57 (5.3%)
Enoxaparin (NA)2/52 (3.8%)
DVT, Symptomatic
Eriksson 2001 11794148Fondaparinux (FXaI)11 days1/831 (0.1%)
Enoxaparin (LMWH)1/840 (0.1%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days6/330 (1.8%)
Fondaparinux 25–31 days (NA)1/326 (0.3%)
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days0/46 (0%)
Enoxaparin (LMWH)0/27 (0%)
Kennedy 2000 10697085Aspirin (Antiplatelet)post-operative days4/73 (5.5%)
VFP (AV impulse system) (Mechanical)2/70 (2.9%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days0/57 (0%)
Enoxaparin (NA)0/52 (0%)
DVT, Total
Eriksson 2001 11794148Fondaparinux (FXaI)11 days49/624 (7.9%)
Enoxaparin (LMWH)117/623 (19%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days74/218 (34%)
Fondaparinux 25–31 days (NA)3/208 (1.4%)
Fisher 2013 23539696Semuloparin 28 days (NA)28 days9/230 (3.9%)
Semuloparin 8 days (NA)17/100 (17%)
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days3/46 (6.5%)
Enoxaparin (LMWH)1/27 (3.7%)
Jørgensen 1992 1314147Placebo (Placebo)Post-operative days18/38 (47%)
Dalteparin (LMWH)5/30 (17%)
Kennedy 2000 10697085Aspirin (NA)post-operative days7/73 (9.6%)
-VFP (AV impulse system) (NA)4/70 (5.7%)
Lassen 2012 22429800 HFxSemuloparin (NA)7–11 days63/379 (17%)
Enoxaparin (NA)79/367 (22%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days14/32 (44%)
Heparin (UFH)6/30 (20%)
Sasaki 2011 21293896Placebo (Placebo)14 days19/29 (66%)
Fondaparinux (FXaI)7/27 (26%)
Enoxaparin (LMWH)16/28 (57%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days5/57 (8.8%)
Enoxaparin (NA)8/52 (15%)
Major adverse event, other
Fisher 2013 23539696Semuloparin 28 days (NA)28 days6/312 (1.9%)
Semuloparin 8 days (NA)7/157 (4.5%)
Fuji 2014B 24680549Edoxaban (FXaI)25–35 days3/59 (5.1%)
Enoxaparin (LMWH)3/29 (10%)
Lassen 2012 22429800 HFxSemuloparin (NA)period from the first injection given during the study up to the last injection plus 3 calendar days days days28/488 (5.7%)
Enoxaparin (NA)27/499 (5.4%)
Mortality, 30 day or in-hospital (AE)
Eriksson 2001 11794148Fondaparinux (FXaI)49 days38/831 (4.6%)
Enoxaparin (LMWH)42/842 (5.0%)
Fisher 2013 23539696Semuloparin 28 days (NA)28 days0/312 (0%)
-Semuloparin 8 days (NA)2/157 (1.3%)
Jørgensen 1992 1314147Placebo (Placebo)Post-operative days4/38 (11%)
Dalteparin (LMWH)3/30 (10%)
Lassen 2012 22429800 HFxSemuloparin (NA)7–11 days4/488 (0.8%)
Enoxaparin (NA)2/499 (0.4%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days2/46 (4.3%)
Heparin (UFH)3/44 (6.8%)
PE, Fatal
Eriksson 2001 11794148Fondaparinux (FXaI)49 days8/831 (1.0%)
Enoxaparin (LMWH)7/840 (0.8%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days1/330 (0.3%)
Fondaparinux 25–31 days (NA)0/326 (0%)
Fisher 2013 23539696Semuloparin 28 days (NA)28 days0/312 (0%)
Semuloparin 8 days (NA)1/157 (0.6%)
F--uji 2014B 24680549Edoxaban (FXaI)11–14 days0/46 (0%)
Enoxaparin (LMWH)0/27 (0%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days0/46 (0%)
Heparin (UFH)0/44 (0%)
Powers 1989 2650646Placebo (Placebo)21 days0/63 (0%)
Aspirin (Antiplatelet)1/66 (1.5%)
Warfarin (VKA)0/65 (0%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days0/66 (0%)
Enoxaparin (NA)0/66 (0%)
PE, Symptomatic
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days0/46 (0%)
Enoxaparin (LMWH)0/27 (0%)
Sasaki 2011 21293896Placebo (Placebo)14 days1/29 (3.4%)
Fondaparinux (FXaI)0/27 (0%)
Enoxaparin (LMWH)0/28 (0%)
PE, Total
Eriksson 2001 11794148Fondaparinux (FXaI)49 days11/831 (1.3%)
Enoxaparin (LMWH)11/840 (1.3%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days3/330 (0.9%)
Fondaparinux 25–31 days (NA)0/326 (0%)
Kennedy 2000 10697085Aspirin (Antiplatelet)post-operative days1/73 (1.4%)
VFP (AV impulse system) (Mechanical)0/70 (0%)
Monreal 1989 2544742Dalteparin (LMWH)Post-operative days6/46 (13%)
Heparin (UFH)0/44 (0%)
Powers 1989 2650646Placebo (Placebo)21 days2/63 (3.2%)
Aspirin (Antiplatelet)1/66 (1.5%)
Warfarin (VKA)0/65 (0%)
The TIFDED Study Group 1999 10844404Dalteparin (NA)Post-operative days0/66 (0%)
Enoxaparin (NA)0/66 (0%)
VTE, Symptomatic
Eriksson 2001 11794148Fondaparinux (FXaI)49 days17/831 (2.0%)
Enoxaparin (LMWH)13/840 (1.5%)
Eriksson 2003 12796070Fondaparinux 6–8 days (NA)32 days9/330 (2.7%)
Fondaparinux 25–31 days (NA)1/326 (0.3%)
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days0/46 (0%)
Enoxaparin (LMWH)0/27 (0%)
-VTE, Total
Fuji 2014B 24680549Edoxaban (FXaI)11–14 days3/46 (6.5%)
Enoxaparin (LMWH)1/27 (3.7%)
Table F4. NRCS total hip replacement.

Table F4

NRCS total hip replacement.

Table F5. NRCS total knee replacement.

Table F5

NRCS total knee replacement.

Table F6. NRCS hip fracture surgery.

Table F6

NRCS hip fracture surgery.

Table F7.1. Network meta-analysis pairwise results: Total hip replacement, intervention class comparisons of DVT.

Table F7.1

Network meta-analysis pairwise results: Total hip replacement, intervention class comparisons of DVT.

Table F7.2. Network meta-analysis pairwise results: Total hip replacement, specific intervention comparisons of DVT.

Table F7.2

Network meta-analysis pairwise results: Total hip replacement, specific intervention comparisons of DVT.

Table F7.3. Network meta-analysis pairwise results: Total hip replacement, intervention class comparisons of major bleeding.

Table F7.3

Network meta-analysis pairwise results: Total hip replacement, intervention class comparisons of major bleeding.

Table F7.4. Network meta-analysis pairwise results: Total hip replacement, specific intervention comparisons of major bleeding.

Table F7.4

Network meta-analysis pairwise results: Total hip replacement, specific intervention comparisons of major bleeding.

Table F7.5. Network meta-analysis pairwise results: Total knee replacement, intervention class comparisons of DVT.

Table F7.5

Network meta-analysis pairwise results: Total knee replacement, intervention class comparisons of DVT.

Table F7.6. Network meta-analysis pairwise results: Total knee replacement, specific intervention comparisons of DVT.

Table F7.6

Network meta-analysis pairwise results: Total knee replacement, specific intervention comparisons of DVT.

Table F7.7. Network meta-analysis pairwise results: Total knee replacement, intervention class comparisons of major bleeding.

Table F7.7

Network meta-analysis pairwise results: Total knee replacement, intervention class comparisons of major bleeding.

Table F7.8. Network meta-analysis pairwise results: Total knee replacement, specific intervention comparisons of major bleeding.

Table F7.8

Network meta-analysis pairwise results: Total knee replacement, specific intervention comparisons of major bleeding.

Table F7.9. Network meta-analysis pairwise results: Hip fracture surgery, intervention class comparisons of DVT.

Table F7.9

Network meta-analysis pairwise results: Hip fracture surgery, intervention class comparisons of DVT.

Table F7.10. Network meta-analysis pairwise results: Hip fracture surgery, specific intervention comparisons of DVT.

Table F7.10

Network meta-analysis pairwise results: Hip fracture surgery, specific intervention comparisons of DVT.

Table F7.11. Network meta-analysis pairwise results: Hip fracture surgery, intervention class comparisons of major bleeding.

Table F7.11

Network meta-analysis pairwise results: Hip fracture surgery, intervention class comparisons of major bleeding.

Table F7.12. Network meta-analysis pairwise results: Hip fracture surgery, specific intervention comparisons of major bleeding.

Table F7.12

Network meta-analysis pairwise results: Hip fracture surgery, specific intervention comparisons of major bleeding.

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