| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| acute myocardial infarction | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CREATE, 2005 | vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| CREATE, 2005 | Reviparin 3436–6871 IU BID for 7 d (weight adjusted) (n=7780) vs. placebo (n=7790) | patients with acute myocardial infarction, STEMI or new LBBB, <=12 h | Double-blind Parallel groups Sample size: 7780/7790 Primary endpoint: Death, MI, or stroke; death, MI, stroke, or recurrent ischemia FU duration: 30 d |
|
| percutaneous coronary intervention | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| REDUCE, 1996 | vs UFH | Ischaemic complication 0.48 [0.25; 0.94] | | safety criteria 0.88 [0.32; 2.38] |
| Trial | Treatments | Patients | Method |
|---|
| REDUCE, 1996 | Reviparin 7,000 IU anti-Xa (n=306) vs. UFH 10,000 IU bolus (n=306) | PTCA with stable/unstable angina | double blind Parallel groups Sample size: 306/306 Primary endpoint: MACE FU duration: 3 days |
|
| pulmonary embolism | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| COLOMBUS sub group, 1997 | vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.96 [0.29; 3.25] |
| Trial | Treatments | Patients | Method |
|---|
| COLOMBUS sub group, 1997 | Reviparin, 3500–6300 IU twice daily, 5 days (n=138) vs. Unfractioned heparin: bolus 5000 IU, infusion 1250 IU/h (n=133) | patients with symptomatic DVT and associated pulmonary embolism sub of of a trial initially enrolling patients with symptomatic venous thromboembolism | open Parallel groups Sample size: 138/133 Primary endpoint: FU duration: 3 mo |
|
| thrombosis prevention | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| vs unfractionated heparin | | | | | Wirth, 2001 | vs unfractionated heparin | | | minor bleeding 3.13 [0.33; 29.65] VTE (symptomatic or asymptomatic) 0.21 [0.02; 1.76] symptomatic VTE 0.00 [0.00; NaN] | | Lassen, 2002 | vs unfractionated heparin | VTE (symptomatic or asymptomatic) 0.50 [0.29; 0.86] | | proximal deep vein thrombosis 0.31 [0.09; 1.10] PE 0.00 [0.00; NaN] distal DVT 0.58 [0.31; 1.07] symptomatic VTE 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Kakkar, 1993 | Reviparin 1750 anti Xa units (n=672) vs. UFH 10 000 units (n=679) | General and gynaecological surgery | Blind Sample size: 672/679 Primary endpoint: FU duration: | | Wirth, 2001 | reviparin 1,750 anti Xa IU Sc once daily for 7-10 days (n=117) vs. no treatment (n=122) | elective knee arthroscopy | open (blind assessement) Parallel groups Sample size: 117/122 Primary endpoint: DVT FU duration: 7-10 days | | Lassen, 2002 | Reviparin 1750 IU (n=183) vs. Placebo (n=188) | patients who required immobilization in a plaster cast or brace for at least five weeks after a leg fracture or rupture of the Achilles tendon | double-blind Parallel groups Sample size: 183/188 Primary endpoint: FU duration: 43 days |
|
