| pathology | Demonstrated benefit and harm | k | | | |
|---|
| atrial fibrillation | versus anticoagulant No demonstrated result for efficacy idraparinux inferior to warfarin standard dose in terms of major bleeding in AMADEUS, 2008 idraparinux inferior to warfarin standard dose in terms of fatal bleeding in AMADEUS, 2008 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AMADEUS, 2008 | idraparinux vs warfarin standard dose | | major bleeding 2.67 [1.74; 4.08] fatal bleeding 7.14 [1.61; 31.58] | all death 1.12 [0.79; 1.58] fatal stroke(ischemic+hemorrhagic) 0.00 [0.00; NaN] thrombo-embolic event (cerebral or systemic) 0.73 [0.40; 1.32] ischemic stroke 0.71 [0.36; 1.43] thromboembolic event likes(TE event or ischemic stroke or systemic embolism) 0.73 [0.40; 1.32] systemic thrombo-embolic complication 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| AMADEUS, 2008 | subcutaneous idraparinux 2·5 mg weekly (n=2283) vs. adjusted-dose vitamin K antagonists (target of an international
normalised ratio of 2–3) (n=2293) | patients with atrial fi brillation at risk for thromboembolism | open Parallel groups Sample size: 2283/2293 Primary endpoint: all stroke and systemic embolism FU duration: 10.7 months |
|
| pulmonary embolism | versus heparin/VKA No demonstrated result for efficacy idraparinux (without heparin) inferior to heparin/VKA in terms of All deaths in VanGogh PE, 2007 idraparinux (without heparin) inferior to heparin/VKA in terms of non fatal PE in VanGogh PE, 2007 idraparinux (without heparin) inferior to heparin/VKA in terms of recurrent VTE in VanGogh PE, 2007 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VanGogh PE, 2007 | idraparinux (without heparin) vs heparin/VKA | | All deaths 1.79 [1.17; 2.74] non fatal PE 5.11 [1.48; 17.62] recurrent VTE 2.10 [1.20; 3.67] | recurrent DVT only 1.02 [0.43; 2.45] Major bleeding 0.51 [0.26; 1.02] fatal PE 2.45 [0.87; 6.94] |
| Trial | Treatments | Patients | Method |
|---|
| VanGogh PE, 2007 | subcutaneous idraparinux (2.5 mg once weekly)
(n=1095) vs. heparin followed by an adjusted-dose vitamin K antagonist
(n=1120)
|
patients with pulmonary embolism
| open Parallel groups Sample size: 1095/1120 Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal) FU duration: 3 mo (6 mo)
|
|
| venous thrombosis | versus anticoagulant No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Van Gogh (subgroup), 2011 | idraparinux vs standard treatment | | | all bleeding 0.89 [0.50; 1.59] deaths at 6 months 0.99 [0.66; 1.48] Recurrent DVT/DVTextension (total) 0.38 [0.14; 1.06] |
| Trial | Treatments | Patients | Method |
|---|
| Van Gogh (subgroup), 2011 | once-weekly subcutaneous injection of idraparinux (2.5 mg) for 6 months (n=220) vs. standard treatment for three months (8%) or six months (92%) (n=201) | non-active and active cancer patients with deep venous thrombosis and without pulmonary embolism, included in the Van Gogh DVT clinical trial | Parallel groups Sample size: 220/201 Primary endpoint: FU duration: 6 months |
|
| venous thrombosis | versus heparin/VKA No demonstrated result for efficacy idraparinux (without heparin) inferior to heparin/VKA in terms of All deaths in VanGogh PE, 2007 idraparinux (without heparin) inferior to heparin/VKA in terms of non fatal PE in VanGogh PE, 2007 idraparinux (without heparin) inferior to heparin/VKA in terms of recurrent VTE in VanGogh PE, 2007 | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VanGogh DVT, 2007 | idraparinux (without heparin) vs heparin/VKA | any bleeding 0.64 [0.48; 0.87] | | recurrent DVT only 0.94 [0.49; 1.83] All deaths 1.03 [0.64; 1.67] Major bleeding 0.71 [0.34; 1.47] non fatal PE 0.95 [0.53; 1.73] fatal PE 1.00 [0.25; 3.99] recurrent VTE during treatment 0.98 [0.64; 1.48] recurrent VTE 0.98 [0.64; 1.48] | | VanGogh PE, 2007 | idraparinux (without heparin) vs heparin/VKA | | All deaths 1.79 [1.17; 2.74] non fatal PE 5.11 [1.48; 17.62] recurrent VTE 2.10 [1.20; 3.67] | recurrent DVT only 1.02 [0.43; 2.45] Major bleeding 0.51 [0.26; 1.02] fatal PE 2.45 [0.87; 6.94] |
| Trial | Treatments | Patients | Method |
|---|
| VanGogh DVT, 2007 | subcutaneous idraparinux (2.5 mg once weekly) (n=1452) vs. heparin followed by an adjusted-dose vitamin K antagonist (n=1452) | patients with deep-vein thrombosis | open Parallel groups Sample size: 1452/1452 Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal) FU duration: 3 mo (6 mo) | | VanGogh PE, 2007 | subcutaneous idraparinux (2.5 mg once weekly)
(n=1095) vs. heparin followed by an adjusted-dose vitamin K antagonist
(n=1120)
|
patients with pulmonary embolism
| open Parallel groups Sample size: 1095/1120 Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal) FU duration: 3 mo (6 mo)
|
|
