| Fondaparinux | thrombosis prevention, in orthopedic surgery | vs placebo | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | no data | | Symptomatic pulmonary embolism | no data | | Symptomatic deep-vein thrombosis | no data | | Venous thromboembolism | no data | | proximal DVT | no data | | Symptomatic venous thromboembolism (DVT, PE) | no data | | non-fatal pulmonary embolism | no data | | fatal pulmonary embolism | no data | | All cause death | no data | | Major bleeding | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| DRI4757, 0 | fondaparinux subcutaneously at 0.75, 1.5, 2.5, and 3.0 mg for at least 10 calendar days, (with a maximum of 14 days) | placebo | Japanese patients undergoing elective total knee replacement surgery |
| |
| Fondaparinux | | vs enoxaparin | Deep vein thrombosis by 52% suggested Venous thromboembolism by 50% suggested proximal DVT by 54% suggested Major bleeding by 38% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | 0.48 [0.40 0.59] | p=0.04 | 0 | 5580 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), L8541, | | Symptomatic pulmonary embolism | 1.41 [0.54 3.70] | p=1.00 | 0 | 6761 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | Symptomatic deep-vein thrombosis | 1.88 [0.69 5.09] | p=1.00 | 0 | 7211 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | Venous thromboembolism | 0.50 [0.41 0.60] | p=0.04 | 0 | 5426 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), L8635, | | proximal DVT | 0.46 [0.30 0.70] | p=0.04 | 0 | 5531 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | Symptomatic venous thromboembolism (DVT, PE) | 1.21 [0.57 2.55] | p=1.00 | 0 | 7211 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | non-fatal pulmonary embolism | 0.85 [0.27 2.65] | p=1.00 | 0 | 7211 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | fatal pulmonary embolism | 0.81 [0.19 3.38] | p=1.00 | 0 | 7211 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | All cause death | 0.74 [0.38 1.43] | p=1.00 | 0 | 7237 | 4 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), | | Major bleeding | 1.38 [1.01 1.89] | p=0.04 | 0 | 7491 | 6 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), L8541, L8635, |
| Trial | Studied treatment | Control | Patients |
|---|
| PENTAMAKS (Bauer), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaparin 30mg twice daily (North america recommendation) | elective major knee surgery | | PENTHIFRA (Eriksson), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaprin 40mg once daily | hip fracture surgery | | PENTATHLON (Turpie), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaparin 30mg twice daily (North america recommendation) | elective hip replacement surgery | | EPHESUS (Lassen), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaprin 40mg once daily | elective hip replacement surgery | | Turpie, 2001 | pentasaccharide Org31540/SR90107A subcutaneous once daily at doses 0.75 mg, 1.5 mg, 3.0 mg, 6.0 mg, and 8.0 mg | enoxaparin 30mg once daily subcutaneous | patients undergoing total hip replacement | | L8541, 0 | fondaparinux 2.5mg subcutaneous once-daily for 7+/-2 days | enoxaparin 40mg s.c. once-daily | chinese patients undergoing major orthopaedic surgery of the lower limbs | | L8635, 0 | Fondaparinux 2.5mg once daily subcutaneously for 7 days | enoxaparin 40mg once daily SC for 7 days | Taiwanese patients undergoing elective knee replacement |
| |
| Fondaparinux | thrombosis prevention, in all type of patients | vs placebo | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | no data | | Symptomatic pulmonary embolism | no data | | Symptomatic deep-vein thrombosis | no data | | Venous thromboembolism | no data | | proximal DVT | no data | | Symptomatic venous thromboembolism (DVT, PE) | no data | | non-fatal pulmonary embolism | no data | | fatal pulmonary embolism | no data | | All cause death | no data | | Major bleeding | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| DRI4757, 0 | fondaparinux subcutaneously at 0.75, 1.5, 2.5, and 3.0 mg for at least 10 calendar days, (with a maximum of 14 days) | placebo | Japanese patients undergoing elective total knee replacement surgery |
| |
| Fondaparinux | | vs placebo (on top intermittent pneumatic comp.) | Deep vein thrombosis by 69% suggested Venous thromboembolism by 69% suggested Major bleeding by 924% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | 0.31 [0.13 0.74] | p=0.04 | 0 | 842 | 1 | APOLLO (Turpie), | | Symptomatic pulmonary embolism | 1.01 [0.02 51.17] | p=1.00 | 0 | 1309 | 1 | APOLLO (Turpie), | | Symptomatic deep-vein thrombosis | no data | | Venous thromboembolism | 0.31 [0.13 0.74] | p=0.04 | 0 | 842 | 1 | APOLLO (Turpie), | | proximal DVT | 0.14 [0.02 1.15] | p=1.00 | 0 | 841 | 1 | APOLLO (Turpie), | | Symptomatic venous thromboembolism (DVT, PE) | 1.01 [0.06 16.24] | p=1.00 | 0 | 1309 | 1 | APOLLO (Turpie), | | non-fatal pulmonary embolism | no data | | fatal pulmonary embolism | no data | | All cause death | 0.51 [0.05 5.66] | p=1.00 | 0 | 1285 | 1 | APOLLO (Turpie), | | Major bleeding | 10.24 [1.31 80.20] | p=0.04 | 0 | 1285 | 1 | APOLLO (Turpie), |
| Trial | Studied treatment | Control | Patients |
|---|
| APOLLO (Turpie), 2007 | fondaparinux 2.5 mg s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression | placebo s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression | Patients aged at least 40 years undergoing abdominal surgery |
| |
| Fondaparinux | | vs enoxaparin | Deep vein thrombosis by 48% suggested Venous thromboembolism by 46% suggested proximal DVT by 50% suggested Major bleeding by 39% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | 0.52 [0.44 0.62] | p=0.04 | 0 | 7622 | 6 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, L8541, | | Symptomatic pulmonary embolism | 1.48 [0.67 3.30] | p=1.00 | 0 | 9688 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | Symptomatic deep-vein thrombosis | 1.65 [0.68 4.01] | p=1.00 | 0 | 10138 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | Venous thromboembolism | 0.54 [0.46 0.64] | p=0.04 | 0 | 7474 | 6 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, L8635, | | proximal DVT | 0.50 [0.33 0.75] | p=0.04 | 0 | 7684 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | Symptomatic venous thromboembolism (DVT, PE) | 1.20 [0.64 2.27] | p=1.00 | 0 | 10138 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | non-fatal pulmonary embolism | 1.05 [0.36 3.07] | p=1.00 | 0 | 10138 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | fatal pulmonary embolism | 0.89 [0.30 2.58] | p=1.00 | 0 | 10138 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | All cause death | 0.74 [0.46 1.19] | p=1.00 | 0 | 10095 | 5 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, | | Major bleeding | 1.39 [1.08 1.79] | p=0.04 | 0 | 10349 | 7 | PENTAMAKS (Bauer), PENTHIFRA (Eriksson), PENTATHLON (Turpie), EPHESUS (Lassen), PEGASUS, L8541, L8635, |
| Trial | Studied treatment | Control | Patients |
|---|
| PENTAMAKS (Bauer), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaparin 30mg twice daily (North america recommendation) | elective major knee surgery | | PENTHIFRA (Eriksson), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaprin 40mg once daily | hip fracture surgery | | PENTATHLON (Turpie), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaparin 30mg twice daily (North america recommendation) | elective hip replacement surgery | | EPHESUS (Lassen), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery | enoxaprin 40mg once daily | elective hip replacement surgery | | Turpie, 2001 | pentasaccharide Org31540/SR90107A subcutaneous once daily at doses 0.75 mg, 1.5 mg, 3.0 mg, 6.0 mg, and 8.0 mg | enoxaparin 30mg once daily subcutaneous | patients undergoing total hip replacement | | PEGASUS, 2005 | once-daily subcutaneous injections of fondaparinux 2·5 mg started 6 h after surgery for 5–9 days | once-daily subcutaneous injections of dalteparin 5000 units for 5–9 days (2500 units each, given 2 h before surgery and 12 h after the preoperative administration) | patients undergoing major abdominal surgery | | L8541, 0 | fondaparinux 2.5mg subcutaneous once-daily for 7+/-2 days | enoxaparin 40mg s.c. once-daily | chinese patients undergoing major orthopaedic surgery of the lower limbs | | L8635, 0 | Fondaparinux 2.5mg once daily subcutaneously for 7 days | enoxaparin 40mg once daily SC for 7 days | Taiwanese patients undergoing elective knee replacement |
| |
| Fondaparinux | thrombosis prevention, in medical patients | vs placebo | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Symptomatic deep-vein thrombosis | 1.01 [0.02 50.87] | p=1.00 | 0 | 644 | 1 | ARTEMIS (Cohen), | | Symptomatic pulmonary embolism | 0.20 [0.01 4.21] | p=1.00 | 0 | 644 | 1 | ARTEMIS (Cohen), | | Deep vein thrombosis | no data | | proximal deep-vein thrombosis | no data | | Venous thromboembolism or death | no data | | asymptomatic DVT | no data | | pulmonary embolism (symptomatic and asymptomatic) | no data | | fatal pulmonary embolism | no data | | Venous thromboembolism | no data | | All cause death | 0.09 [0.01 1.66] | p=1.00 | 0 | 644 | 1 | ARTEMIS (Cohen), | | Major bleeding | 0.97 [0.06 15.63] | p=1.00 | 0 | 839 | 1 | ARTEMIS (Cohen), | | net benefit | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| ARTEMIS (Cohen), 2006 | Fondaparinux 2.5 mg once daily for 6–14 days | placebo
| High-risk medical patients |
| |
| Fondaparinux | thrombosis prevention, in abdominal surgery | vs placebo (on top intermittent pneumatic comp.) | Deep vein thrombosis by 69% suggested Venous thromboembolism by 69% suggested Major bleeding by 924% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | 0.31 [0.13 0.74] | p=0.04 | 0 | 842 | 1 | APOLLO (Turpie), | | Symptomatic pulmonary embolism | 1.01 [0.02 51.17] | p=1.00 | 0 | 1309 | 1 | APOLLO (Turpie), | | Symptomatic deep-vein thrombosis | no data | | Venous thromboembolism | 0.31 [0.13 0.74] | p=0.04 | 0 | 842 | 1 | APOLLO (Turpie), | | proximal DVT | 0.14 [0.02 1.15] | p=1.00 | 0 | 841 | 1 | APOLLO (Turpie), | | Symptomatic venous thromboembolism (DVT, PE) | 1.01 [0.06 16.24] | p=1.00 | 0 | 1309 | 1 | APOLLO (Turpie), | | non-fatal pulmonary embolism | no data | | fatal pulmonary embolism | no data | | All cause death | 0.51 [0.05 5.66] | p=1.00 | 0 | 1285 | 1 | APOLLO (Turpie), | | Major bleeding | 10.24 [1.31 80.20] | p=0.04 | 0 | 1285 | 1 | APOLLO (Turpie), |
| Trial | Studied treatment | Control | Patients |
|---|
| APOLLO (Turpie), 2007 | fondaparinux 2.5 mg s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression | placebo s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression | Patients aged at least 40 years undergoing abdominal surgery |
| |
| Fondaparinux | | vs enoxaparin | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Deep vein thrombosis | 0.72 [0.48 1.08] | p=1.00 | 0 | 2042 | 1 | PEGASUS, | | Symptomatic pulmonary embolism | 1.66 [0.40 6.97] | p=1.00 | 0 | 2927 | 1 | PEGASUS, | | Symptomatic deep-vein thrombosis | 1.00 [0.14 7.09] | p=1.00 | 0 | 2927 | 1 | PEGASUS, | | Venous thromboembolism | 0.75 [0.51 1.11] | p=1.00 | 0 | 2048 | 1 | PEGASUS, | | proximal DVT | 1.00 [0.29 3.47] | p=1.00 | 0 | 2153 | 1 | PEGASUS, | | Symptomatic venous thromboembolism (DVT, PE) | 1.20 [0.36 3.93] | p=1.00 | 0 | 2927 | 1 | PEGASUS, | | non-fatal pulmonary embolism | 4.99 [0.24 104.03] | p=1.00 | 0 | 2927 | 1 | PEGASUS, | | fatal pulmonary embolism | 1.00 [0.20 4.95] | p=1.00 | 0 | 2927 | 1 | PEGASUS, | | All cause death | 0.75 [0.38 1.46] | p=1.00 | 0 | 2858 | 1 | PEGASUS, | | Major bleeding | 1.39 [0.90 2.16] | p=1.00 | 0 | 2858 | 1 | PEGASUS, |
| Trial | Studied treatment | Control | Patients |
|---|
| PEGASUS, 2005 | once-daily subcutaneous injections of fondaparinux 2·5 mg started 6 h after surgery for 5–9 days | once-daily subcutaneous injections of dalteparin 5000 units for 5–9 days (2500 units each, given 2 h before surgery and 12 h after the preoperative administration) | patients undergoing major abdominal surgery |
| |
