| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute coronary syndrome | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RESCUE | enoxaparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| RESCUE | Enoxaparin (n=-9) vs. unfractionated heparin (n=-9) | patients diagnosed with acute coronary syndrome in the emergency department | open Parallel groups Sample size: -9/-9 Primary endpoint: death, MI, recurrent angina requiring revasc FU duration: 30 days |
|
| acute coronary syndrome | versus LMWH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EVET, 2005 | enoxaparin vs tinzaparin | recurrent angina 0.61 [0.39; 0.96] death, myocardial infarction, or recurrent at 30 days 0.63 [0.44; 0.90] | | death 0.50 [0.05; 5.42] myocardial infarction 0.25 [0.03; 2.20] death at 30 days 0.50 [0.05; 5.42] myocardial infarction at 30 days 0.17 [0.02; 1.36] |
| Trial | Treatments | Patients | Method |
|---|
| EVET, 2005 | enoxaparin, 100 IU/kg subcutaneously twice daily +aspirin for 7 days (n=220) vs. tinzaparin, 175 IU/kg subcutaneously once daily +aspirin for 7 days (n=218) | patients with non-ST-segment elevation acute coronary syndromes | open Parallel groups Sample size: 220/218 Primary endpoint: FU duration: 30 days |
|
| acute coronary syndrome | versus UFH No demonstrated result for efficacy enoxaparin inferior to UFH (on top of aspirin) in terms of minor bleeding in ESSENCE, 1997 enoxaparin inferior to UFH (on top of aspirin) in terms of minor bleeding in TIMI 11 B (short term), 1998 enoxaparin inferior to UFH (on top of aspirin) in terms of major bleeding in SYNERGY, 2005 enoxaparin inferior to UFH (on top of aspirin) in terms of minor bleeding in INTERACT, 2006 enoxaparin inferior to UFH (on top of aspirin) in terms of major bleeding in TIMI 11 B (long term), 1998 enoxaparin inferior to UFH (on top of aspirin) in terms of minor bleeding in TIMI 11 B (long term), 1998 | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ESSENCE, 1997 | enoxaparin vs UFH (on top of aspirin) | death, MI and recurrence 0.84 [0.72; 0.97] all revascularisations 0.84 [0.75; 0.93] recurrent angina 0.83 [0.70; 0.98] death, myocardial infarction, or recurrent at 14 days 0.84 [0.72; 0.97] death, myocardial infarction, or recurrent at 30 days 0.85 [0.74; 0.97] | minor bleeding 1.66 [1.33; 2.08] | recurrent angina at 14 days 0.87 [0.75; 1.02] death 0.97 [0.62; 1.54] major bleeding 0.93 [0.71; 1.21] stroke at 30 days 0.97 [0.34; 2.77] myocardial infarction 0.71 [0.50; 1.01] Drop in platelet count of 50% 0.68 [0.45; 1.01] myocardial infarction or death 0.83 [0.43; 1.57] death at 30 days 0.79 [0.54; 1.15] myocardial infarction at 30 days 0.74 [0.54; 1.03] | | TIMI 11 B (short term), 1998 | enoxaparin vs UFH (on top of aspirin) | myocardial infarction 0.71 [0.52; 0.97] | minor bleeding 3.66 [2.68; 5.01] | death, MI and revascularization 0.85 [0.73; 1.00] death 0.83 [0.53; 1.30] all revascularisations 0.88 [0.72; 1.07] major bleeding 1.52 [0.86; 2.71] myocardial infarction or death 0.78 [0.60; 1.03] | | SYNERGY, 2005 | enoxaparin vs UFH (on top of aspirin) | | major bleeding 1.19 [1.05; 1.36] | long term MI or death 0.96 [0.87; 1.06] death 1.04 [0.84; 1.30] minor bleeding 1.01 [0.91; 1.12] myocardial infarction 0.94 [0.85; 1.05] myocardial infarction or death 0.96 [0.87; 1.06] death at 30 days 1.04 [0.84; 1.30] myocardial infarction at 30 days 0.92 [0.83; 1.03] | | INTERACT, 2006 | enoxaparin vs UFH (on top of aspirin) | long term MI or death 0.55 [0.32; 0.96] major bleeding 0.40 [0.17; 0.95] myocardial infarction or death 0.55 [0.32; 0.96] | minor bleeding 1.31 [1.04; 1.65] | death, MI and revascularization 0.87 [0.61; 1.22] death, MI and recurrence 1.30 [0.86; 1.98] death 0.58 [0.26; 1.30] all revascularisations 1.35 [0.77; 2.35] myocardial infarction 0.69 [0.36; 1.31] recurrent angina 0.45 [0.19; 1.09] death, myocardial infarction, or recurrent at 30 days 0.71 [0.47; 1.08] death at 30 days 0.58 [0.26; 1.30] myocardial infarction at 30 days 0.69 [0.36; 1.31] | | TIMI 11 B (long term), 1998 | enoxaparin vs UFH (on top of aspirin) | | major bleeding 1.90 [1.08; 3.34] minor bleeding 3.68 [2.81; 4.82] | long term MI or death 0.89 [0.73; 1.10] death, MI and revascularization 0.88 [0.77; 1.00] death 0.96 [0.71; 1.31] all revascularisations 0.84 [0.71; 1.00] myocardial infarction 0.83 [0.65; 1.07] myocardial infarction or death 0.89 [0.73; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| ESSENCE, 1997 | enoxaparin 1mg/kg, twice daily during 48h-8days (n=1607) vs. continuous intravenous unfractionated heparin (n=1564) | patients with angina at rest or non–Q-wave myocardial infarction | Double blind Parallel groups Sample size: 1607/1564 Primary endpoint: FU duration: 14 days (30 days) | | TIMI 11 B (short term), 1998 | enoxaprin during both the acute phase and outpatient phase (n=1953) vs. intravenous UFH for >=3 days (followed by
subcutaneous placebo injections) (n=1957) | unstable angina/non–Q-wave myocardial infarction | double blind Parallel groups Sample size: 1953/1957 Primary endpoint: death, myocardial infarction, or urgent revascularization FU duration: 8 days (43 days) | | SYNERGY, 2005 | Enoxaparin 1 mg/kg twice daily (n=4993) vs. unfractionated heparin (n=4985) | high-risk patients with acute coronary syndromes | open Parallel groups Sample size: 4993/4985 Primary endpoint: death/MI FU duration: 30 days | | INTERACT, 2006 | enoxaparin (1 mg/kg subcutaneously twice daily) for 48 hours (+eptifibatide and aspirin) (n=380) vs. intravenous UFH (70 U/kg bolus followed by 15 U/kg per hour adjusted to an activated partial thromboplastin time of 1.5-2 times control) for 48 hours (+eptifibatide and aspirin) (n=366) | high-risk patients with ACS receiving aspirin and eptifibatide | open Parallel groups Sample size: 380/366 Primary endpoint: 96-hour non–CABG related major bleeding FU duration: 30 days (2.5y) | | TIMI 11 B (long term), 1998 | enoxaprin during both the acute phase (IV) and outpatient phase (SC)
(n=1953) vs. intravenous UFH for >=3 days (followed by subcutaneous placebo injections) (n=1957)
| unstable angina/non–Q-wave myocardial infarction
| double blind Sample size: 1953/1957 Primary endpoint: death, MI or urgent revascularization FU duration: 43 days |
|
| acute myocardial infarction | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AMI-SK, 2002 | Enoxaparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| AMI-SK, 2002 | Enoxaparin 30 mg IV bolus, 1 mg/kg for 3–8 d (n=253) vs. placebo (n=243) | patients with evolving myocardial infarction, Age >=18 y, STEMI | Double-blind Parallel groups Sample size: 253/243 Primary endpoint: Angiographic TIMI flow in infarct-related vessel FU duration: 30 d |
|
| acute myocardial infarction | versus heparin No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASSENT 3, 2001 | Enoxaparin vs UFH | reinfarction at 30 days 0.64 [0.46; 0.88] | | death at 30 dayas 0.89 [0.69; 1.15] | | HART II, 2001 | Enoxaparin vs UFH | | | reinfarction at 30 days 1.00 [0.38; 2.61] death at 30 dayas 0.90 [0.37; 2.17] | | Baird, 2002 | Enoxaparin vs UFH | | | reinfarction at 30 days 0.74 [0.45; 1.23] death at 30 dayas 0.57 [0.26; 1.25] | | ENTIRE-TIMI 2, 2002 | Enoxaparin vs UFH | reinfarction at 30 days 0.15 [0.04; 0.54] | | death at 30 dayas 0.68 [0.16; 2.98] | | ASSENT 3 Plus, 2003 | Enoxaparin vs UFH | | | death at 30 dayas 1.25 [0.87; 1.80] |
| Trial | Treatments | Patients | Method |
|---|
| ASSENT 3, 2001 | Enoxaparin 1 mg/kg BID, <=7d (n=2040) vs. UFH 60 U/kg bolus, then 12 IU/kg per h for 48 h (n=2038) | patients with acute myocardial infarction | open Parallel groups Sample size: 2040/2038 Primary endpoint: In-hospital MI or RI FU duration: 30 d | | HART II, 2001 | Enoxaparin 1 mg/kg BID, <=3d (n=200) vs. UFH 4000–5000 IU bolus, then 15 IU/kg per hour for >=3d (n=200) | patients undergoing reperfusion therapy with an accelerated recombinant tissue plasminogen activator regimen and aspirin for AMI | open Parallel groups Sample size: 200/200 Primary endpoint: infarct-related artery patency FU duration: 5–7 d | | Baird, 2002 | Enoxaparin 40 mg TID, 4 d (n=149) vs. UFH 5000 IU bolus, then 30 000 IU over 24 h for 4d (n=151) | patients receiving fibrinolytic therapy following acute myocardial infarction | 90-min TIMI flow Parallel groups Sample size: 149/151 Primary endpoint: death, non-fatal reinfarction, or readmission with unstable angina FU duration: 90 d | | ENTIRE-TIMI 2, 2002 | Enoxaparin 1 mg/kg BID, <=8d (n=160) vs. UFH 60 IU/kg, then 12 IU/kg per h for >=3d (n=82) | Patients with ST-elevation MI presenting <6 hours from symptom onset were | open Parallel groups Sample size: 160/82 Primary endpoint: MI, death, readmit for UA FU duration: 30 d | | ASSENT 3 Plus, 2003 | Enoxaparin 1 mg/kg BID, <=7d (n=818) vs. UFH 60 IU/kg, then 12 IU/kg per h for >=3d (n=821) | patients with ST-elevation myocardial infarction | open Parallel groups Sample size: 818/821 Primary endpoint: Angiographic TIMI flow FU duration: 30 d |
|
| heart failure | versus UFH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| THE-PRINCE (Kleber), 2003 | enoxaparin vs UFH | | | |
| Trial | Treatments | Patients | Method |
|---|
| THE-PRINCE (Kleber), 2003 | enoxaparin 40mg once daily for 10+/-2 days (n=164) vs. UFH 5000 IU 3 times daily for 10+/-2 days (n=169) | patients hospitalized for severe respiratory disease or heart failure (NYHA III, IV) Patients
were stratified and enrolled according to their underlying disease: severe respiratory disease or heart failure | open Parallel groups Sample size: 164/169 Primary endpoint: thromboembolic event FU duration: |
|
| percutaneous coronary intervention | versus heparin No demonstrated result for efficacy | 9 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| STEEPLE, 2006 | enoxaparin vs UFH | | | | | Rabah, 1999 | enoxaparin vs UFH | | | safety criteria 1.00 [0.07; 15.26] Ischaemic complication 1.00 [0.22; 4.56] | | CRUISE, 2003 | enoxaparin vs UFH | | | safety criteria 0.00 [0.00; NaN] Ischaemic complication 1.13 [0.50; 2.56] | | Galeote, 2001 | enoxaparin vs UFH | | | safety criteria 0.25 [0.03; 2.12] Ischaemic complication 1.63 [0.41; 6.47] | | Dudek, 2000 | enoxaparin vs UFH | | | safety criteria NaN [NaN; NaN] Ischaemic complication 1.25 [0.50; 3.10] | | Dudek b (enox alone), 2000 | enoxaparin vs UFH | | | | | Drozd, 2001 | enoxaparin vs UFH | | | safety criteria NaN [NaN; NaN] Ischaemic complication 1.00 [0.21; 4.72] | | Dubek b (+abciximal), 2001 | enoxaparin+abciximab vs UFH | | | | | ATOLL, 2010 | enoxaparin vs UFH | | | |
| Trial | Treatments | Patients | Method |
|---|
| STEEPLE, 2006 | enoxaparin (0.5 or 0.75 mg per kilogram of body weight) (n=-9) vs. unfractionated heparin (adjusted for activated clotting time) (n=-9) | elective percutaneous coronary intervention. | open Parallel groups Sample size: -9/-9 Primary endpoint: major or minor bleeding FU duration: | | Rabah, 1999 | Enoxaparin 1 mg/kg bolus (n=30) vs. UFH 10,000 IU bolus, then titrated to ACT > 300 (n=30) | PCI for stable angina | open Parallel groups Sample size: 30/30 Primary endpoint: none defined FU duration: | | CRUISE, 2003 | Enoxaparin 0.75 mg/kg bolus (n=129) vs. UFH 60 IU/kg bolus, then titrated to ACT > 200 (n=132) | Urgent or elective PCI | open Parallel groups Sample size: 129/132 Primary endpoint: hemoglobin FU duration: 2,7 +30 days | | Galeote, 2001 | Enoxaparin 0.75 mg/kg bolus (n=50) vs. UFH 70 U/kg bolus, then titrated to ACT > 200 (n=49) | PTCA patients with stable/unstable angina or AMI | Sample size: 50/49 Primary endpoint: FU duration: | | Dudek, 2000 | Enoxaparin 1 mg/kg bolus (n=200) vs. UFH titrated to ACT > 300 (n=200) | PCI | Sample size: 200/200 Primary endpoint: FU duration: 3à days | | Dudek b (enox alone), 2000 | Enoxaparin 1 mg/kg bolus (n=-9) vs. UFH titrated to ACT > 300 (n=50) | PTCA complex lesionsCI | Sample size: -9/50 Primary endpoint: FU duration: | | Drozd, 2001 | Enoxaparin 1 mg/kg bolus (n=50) vs. UFH 100 IU/kg bolus (n=50) | PCI for stable angina | Sample size: 50/50 Primary endpoint: FU duration: 24hrs, 30 days | | Dubek b (+abciximal), 2001 | Enoxaparin 0.75 mg/kg bolus + abciximab (n=-9) vs. UFH titrated to ACT > 300 (n=50) | | Sample size: -9/50 Primary endpoint: FU duration: | | ATOLL, 2010 | IV enoxaparin (n=450) vs. UFH (n=460) | patients undergoing PCI for acute STEMI | open Parallel groups Sample size: 450/460 Primary endpoint: Death, Complication of MI, Procedure Failure or Major Bleeding FU duration: 30 days |
|
| pulmonary embolism | versus unfractioned heparin No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PREPIC, 1998 | Enoxaparin vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.33 [0.04; 2.84] | | Merli sub group, 2001 | Enoxaparin vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.66 [0.11; 3.90] |
| Trial | Treatments | Patients | Method |
|---|
| PREPIC, 1998 | Enoxaparin, 1 mg/kg twice daily, 8-12 days (n=41) vs. Unfractioned heparin: bolus 5000 IU, infusion 500 IU/kg per day (n=54) factorial design comparing vena caval filters and enoxaparin | patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism | open Factorial plan Sample size: 41/54 Primary endpoint: recurrent VTE, death, and major bleeding FU duration: 2 y | | Merli sub group, 2001 | Enoxaparin, 1mg/kg twice daily or 1.5 mg/kg once daily, 5 days (n=199) vs. Unfractioned heparin: according nomogram at local institution (n=88) | patients with confirmed pulmonary embolism sub group of a trial initially enrolling patients with symptomatic lower-extremity deep venous thrombosis | open Parallel groups Sample size: 199/88 Primary endpoint: none defined FU duration: 3 mo |
|
| superficial thrombophlebitis | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Stenox (enoxaparin 40mg), 2003 | enoxaparin vs placebo | | | | | STENOX (enoxaparin 1.5mg/hg), 2003 | enoxaparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Stenox (enoxaparin 40mg), 2003 | LMWH (enoxaparin) (s.c. 40 mg) for 8-12 days (n=-9) vs. placebo. (n=-9) | patients with ST of at least 5 cm on ultrasonography examination | Sample size: -9/-9 Primary endpoint: FU duration: | | STENOX (enoxaparin 1.5mg/hg), 2003 | enoxaparin (s.c. 1.5 mg/kg)for 8-12 days (n=-9) vs. placebo (n=-9) | patients with St of at least 5 cm on ultrasonography examination | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| thrombosis prevention | versus placebo or control No demonstrated result for efficacy enoxaparin inferior to no treatment in terms of total bleeding in Ho [43] | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LeGagneux , 1987 | enoxaparin vs placebo | | | major Bleeding 1.36 [0.52; 3.61] Pulmonary embolism NaN [NaN; NaN] Asymptomatic Deep vein thrombosis NaN [NaN; NaN] symptomatic thromboembolism event NaN [NaN; NaN] transfusin 1.36 [0.52; 3.61] | | MEDENOX, 1999 | Enoxaparin vs placebo | Asymptomatic deep vein thrombosis during follow-up. 0.39 [0.22; 0.67] | | All-cause death during follow-up 0.74 [0.36; 1.54] Major bleeding during follow-up 1.48 [0.42; 5.21] Symptomatic pulmonary embolism during follow-up 0.00 [0.00; NaN] DVT 0.72 [0.49; 1.05] PE 0.17 [0.02; 1.52] Symptomatic deep vein thrombosis during follow-up 0.49 [0.05; 5.43] | | Lederle, 2006 | Enoxaparin vs placebo | | | Major bleeding during follow-up 0.40 [0.08; 2.03] Symptomatic pulmonary embolism during follow-up 0.33 [0.04; 3.17] PE 0.33 [0.04; 3.17] Symptomatic deep vein thrombosis during follow-up 0.63 [0.21; 1.86] | | Ho [43] | enoxaparin vs no treatment | | total bleeding 3.78 [1.04; 13.70] | wound hematoma ∞ [NaN; ∞] symptomatic thromboembolism event 0.00 [0.00; NaN] transfusin 1.43 [0.85; 2.43] | | Agnelli, 1998 | enoxaparin vs placebo | thromboembolic events (symptomatic or asymptomatic) 0.51 [0.33; 0.80] proxymal DVT 0.39 [0.17; 0.90] | | | | Melon, 1987 | enoxaparin vs placebo | | | thromboembolic events (symptomatic or asymptomatic) 0.65 [0.31; 1.34] | | Canata, 2003 | enoxaparin vs control | | | minor bleeding 1.50 [0.28; 7.93] VTE (symptomatic or asymptomatic) NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| LeGagneux , 1987 | Enoxaparin 6000 anti-Xa units (n=44) vs. Placebo (n=45) | prostatectomy surgery | Blind Sample size: 44/45 Primary endpoint: FU duration: | | MEDENOX, 1999 | Enoxaparin 20 mg or 40 mg once daily, 6–14 days (n=291) vs. placebo (n=288) 3 arms: 40 mg of enoxaparin, 20 mg of enoxaparin, or placebo subcutaneously once daily for 6 to 14 days | Acute decompensated chronic obstructive pulmonary disease with mechanical ventilation | double blind Parallel groups Sample size: 291/288 Primary endpoint: FU duration: 6-14 days | | Lederle, 2006 | Enoxaparin 40 mg once daily, until hospital discharge (n=140) vs. placebo (n=140) | Hospitalization in general medical unit | double blind Parallel groups Sample size: 140/140 Primary endpoint: FU duration: 90 days | | Ho [43] | Enoxaparin 4000 anti-Xa units (n=134) vs. No treatment (n=169) | | Open Sample size: 134/169 Primary endpoint: FU duration: | | Agnelli, 1998 | Enoxaparin, 40 mg/d subcutaneously within 24 hours postoperatively plus compression stockings for >=7 days (n=153) vs. compression stockings + placebo (n=154) | Elective neurosurgery, 18 years or older, without excess bleeding risk | Sample size: 153/154 Primary endpoint: FU duration: 30 days | | Melon, 1987 | Enoxaparin, 20 mg/d subcutaneously 18-24 hours postoperatively for 10 days (n=67) vs. placebo (n=63) | Neurosurgery, adult, 45-90 kg of weight, without excess bleeding risk | Sample size: 67/63 Primary endpoint: FU duration: NA | | Canata, 2003 | enoxaparin sc daily (dose not specified) (n=18) vs. no treatment (n=18) | ACL reconstruction for symptomatic ACL-deficient knees | Parallel groups Sample size: 18/18 Primary endpoint: FU duration: 6 days |
|
| thrombosis prevention | versus placebo or no treatment No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Turpie, 1986 | enoxaparin vs placebo | | | | | Leclerc, 1991 | enoxaparin vs placebo | | | | | Samama, 1997 | enoxaparin vs placebo | | | | | Kalodiki, 1996 | enoxaparin vs placebo | | | | | Warwick, 1995 | enoxaparin vs no treatment | | | |
| Trial | Treatments | Patients | Method |
|---|
| Turpie, 1986 | Enoxaparin 3000 x2 (n=50) vs. Placebo (n=50) | Elective hip | double blind Sample size: 50/50 Primary endpoint: FU duration: 14 days or discharge | | Leclerc, 1991 | Enoxaparin 3000 x2 (n=65) vs. Placebo (n=64) | Knee | double blind Sample size: 65/64 Primary endpoint: FU duration: 14 days | | Samama, 1997 | enoxaparin 4000x1+elastic stockings (n=85) vs. Placebo+elastic stockings (n=85) | Elective hip | double blind Sample size: 85/85 Primary endpoint: FU duration: 8-12 days | | Kalodiki, 1996 | enoxaparin 4000x1 (n=13) vs. Placebo (n=14) | Elective hip | double blind Sample size: 13/14 Primary endpoint: FU duration: discharge (8-12 days ) | | Warwick, 1995 | enoxaparin 4000x1 + elastic stockings (n=78) vs. no treatment + elastic stockings (n=78) | Elective hip | open Sample size: 78/78 Primary endpoint: FU duration: 8-10 days |
|
| thrombosis prevention | versus No demonstrated result for efficacy | 13 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Samama 1, 1988 | enoxaparin vs unfractionated heparin | | | death ∞ [NaN; ∞] total haemorrhage 0.50 [0.15; 1.62] major haemorrhage 0.99 [0.06; 15.76] clinical PE NaN [NaN; NaN] asymptomatic DVT 0.50 [0.19; 1.29] wound hematoma 0.25 [0.02; 2.70] symptomatic thromboembolism ∞ [NaN; ∞] transfusion 1.21 [0.93; 1.57] | | Samama 2, 1988 | enoxaparin vs unfractionated heparin | | | death ∞ [NaN; ∞] total haemorrhage 0.68 [0.34; 1.37] major haemorrhage ∞ [NaN; ∞] clinical PE NaN [NaN; NaN] asymptomatic DVT 1.04 [0.21; 5.03] wound hematoma 0.67 [0.20; 2.26] symptomatic thromboembolism 0.00 [0.00; NaN] transfusion 0.97 [0.73; 1.29] | | Samama 3, 1988 | enoxaparin vs unfractionated heparin | | | death ∞ [NaN; ∞] total haemorrhage 0.92 [0.51; 1.67] major haemorrhage 0.92 [0.06; 14.56] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 0.78 [0.21; 2.83] wound hematoma 0.94 [0.29; 3.00] symptomatic thromboembolism 0.46 [0.04; 5.01] transfusion 1.05 [0.84; 1.31] | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | Bergqvist, 1996 | out of hospital Enoxaparin vs standard prophylaxis | Proximal deep vein thrombosis 0.28 [0.13; 0.60] Symptomless venous thromboembolism 0.48 [0.31; 0.76] Symptomatic venous thromboembolism 0.20 [0.04; 0.89] | | Death NaN [NaN; NaN] Major bleeding NaN [NaN; NaN] Minor bleeding 5.95 [0.73; 48.65] Pulmonary embolism 0.00 [0.00; NaN] Distal deep vein thrombosis 0.86 [0.43; 1.72] symptomatic deep vein thrombosis 0.25 [0.05; 1.14] | | Planes, 1996 | out of hospital Enoxaparin vs standard prophylaxis | | | Death NaN [NaN; NaN] Major bleeding NaN [NaN; NaN] Minor bleeding 2.97 [0.31; 27.98] Pulmonary embolism NaN [NaN; NaN] Proximal deep vein thrombosis 1.04 [0.21; 4.99] Distal deep vein thrombosis 0.00 [0.00; NaN] Symptomless venous thromboembolism 0.31 [0.09; 1.09] Symptomatic venous thromboembolism 0.44 [0.12; 1.66] symptomatic deep vein thrombosis 0.44 [0.12; 1.66] | | Comp, 2001 | out of hospital Enoxaparin vs standard prophylaxis | Proximal deep vein thrombosis 0.31 [0.21; 0.47] Symptomless venous thromboembolism 0.67 [0.48; 0.93] Symptomatic venous thromboembolism 0.20 [0.04; 0.89] | | Death 0.00 [0.00; NaN] Major bleeding 0.00 [0.00; NaN] Minor bleeding 0.98 [0.41; 2.33] Pulmonary embolism 0.00 [0.00; NaN] Distal deep vein thrombosis 0.85 [0.56; 1.29] symptomatic deep vein thrombosis 0.24 [0.05; 1.15] | | LIFENOX, 2011 | enoxaparin vs placebo | | | All-cause death during follow-up 1.00 [0.82; 1.22] Major bleeding during follow-up 1.40 [0.67; 2.94] |
| Trial | Treatments | Patients | Method |
|---|
| Samama 1, 1988 | Enoxaparin 2000 (n=168) vs. UFH 15 000 units (n=167) | General surgery | Open Sample size: 168/167 Primary endpoint: FU duration: 7 days | | Samama 2, 1988 | Enoxaparin 4000 (n=127) vs. UFH 15 000 units (n=123) | General surgery | Open Sample size: 127/123 Primary endpoint: FU duration: 7 days | | Samama 3, 1988 | Enoxaparin 6000 (n=160) vs. UFH 15 000 units (n=147) | General surgery | Open Sample size: 160/147 Primary endpoint: FU duration: 7 days | | Kaaja, 1992 | Enoxaparin 2000 anti Xa units (n=37) vs. UFH 10 000 units (n=31) | Gynaecological surgery | Blind Sample size: 37/31 Primary endpoint: FU duration: | | Gazzaniga (ISG), 1993 | Enoxaparin 2000 anti Xa units (n=561) vs. UFH 10 000 units (n=561) | General and vascular surgery | Open Sample size: 561/561 Primary endpoint: FU duration: | | Nurmohamed, 1995 | Enoxaparin 2000 anti Xa units (n=737) vs. UFH 15 000 units (n=734) | General surgery | Blind Sample size: 737/734 Primary endpoint: FU duration: | | McLeod (Canadian), 1995 | Enoxaparin 4000 anti Xa units (n=674) vs. UFH 15 000 units (n=675) | Colorectal surgery | Blind Sample size: 674/675 Primary endpoint: FU duration: | | Gonzalez, 1996 | Bemiparin 2500 anti Xa units (n=84) vs. UFH 10 000 units (n=82) | Abdominal surgery | Blind Sample size: 84/82 Primary endpoint: FU duration: | | ENOXACAN, 1997 | Enoxaparin 4000 anti Xa units (n=555) vs. UFH 15 000 units (n=560) | Abdominopelvic surgery | Blind Sample size: 555/560 Primary endpoint: FU duration: | | Bergqvist, 1996 | in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 30 days (n=117) vs. Enoxaparin 40 mg once a day for 10-11 days (n=116) | THR | Sample size: 117/116 Primary endpoint: FU duration: | | Planes, 1996 | in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 35 days (n=90) vs. Enoxaparin 40 mg once a day for 13-15 days (n=89) | THR | Sample size: 90/89 Primary endpoint: FU duration: | | Comp, 2001 | in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 27-29 days (n=441) vs. Enoxaparin 30 mg twice a day for 7-10 days (n=432) | THR or TKR | Sample size: 441/432 Primary endpoint: FU duration: | | LIFENOX, 2011 | subcutaneous enoxaparin 40 mg daily for 10±4 days (n=4171) vs. placebo (n=4136) | hospitalized, acutely ill medical patients | double-blind Parallel groups Sample size: 4171/4136 Primary endpoint: death from any cause FU duration: 30 days |
|
| thrombosis prevention | versus Dextran No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DES Group , 1991 | enoxaparin vs Dextran | | | |
| Trial | Treatments | Patients | Method |
|---|
| DES Group , 1991 | Enoxaparin (n=120) vs. Dextran (n=126) | Elective hip | Sample size: 120/126 Primary endpoint: FU duration: |
|
| thrombosis prevention | versus UFH No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bergmann and Neuhart, 1996 | enoxaparin vs UFH | | | All-cause death during follow-up 0.90 [0.33; 2.45] DVT 0.94 [0.39; 2.26] PE 3.13 [0.13; 75.88] | | Lechler, 1996 | enoxaparin vs UFH | | | All-cause death during follow-up 0.64 [0.25; 1.64] DVT 0.25 [0.03; 2.16] PE 0.11 [0.01; 1.58] | | Kleber, 2003 | enoxaparin vs UFH | | | All-cause death during follow-up 0.60 [0.27; 1.35] DVT 0.77 [0.43; 1.38] PE 0.89 [0.06; 13.64] |
| Trial | Treatments | Patients | Method |
|---|
| Bergmann and Neuhart, 1996 | enoxaparin 20 mg once daily for 10 days (n=-9) vs. unfractionated heparin (UFH) 5000 IU twice daily (n=-9) | elderly in-patients bedridden for an acute medical illness | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 10 days | | Lechler, 1996 | enoxaparin 40 mg (n=-9) vs. unfractionated heparin (Ca-heparin), 3 x 5,000 U) (n=-9) | hospitalized medical patients | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 7 days | | Kleber, 2003 | enoxaparin 40 mg once daily for 10 +/2 days (n=-9) vs. UFH 5000 IU 3 times daily for 10 +/2 days (n=-9) | severe respiratory disease or heart failure | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 10 +/- 2 days |
|
| thrombosis prevention | versus Unfractionated heparin No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Planes , 1988 | enoxaparin vs Unfractionated heparin | | | | | Levine , 1991 | enoxaparin vs Unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Planes , 1988 | Enoxaparin (n=124) vs. Unfractionated heparin (n=113) | Elective hip | Sample size: 124/113 Primary endpoint: FU duration: | | Levine , 1991 | Enoxaparin (n=333) vs. Unfractionated heparin (n=332) | Elective hip | Sample size: 333/332 Primary endpoint: FU duration: |
|
| venous thrombosis | versus anticoagulant No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Cesarone, 2003 | extended enoxaparin vs standard treatment | | | All-cause mortality 0.67 [0.11; 3.90] Recurrent DVT/DVTextension (total) 0.66 [0.16; 2.74] death at 3 months 0.67 [0.11; 3.90] | | Deitcher, 2006 | extended enoxaparin vs standard treatment | | | All-cause mortality 1.01 [0.56; 1.84] deaths at 6 months 1.01 [0.56; 1.84] Major hemorrhage 3.04 [0.38; 24.28] | | Meyer, 2002 | extended enoxaparin vs standard treatment | | | All-cause mortality 0.80 [0.51; 1.26] deaths at 6 months 0.80 [0.51; 1.26] Major hemorrhage 0.44 [0.16; 1.19] Recurrent DVT/DVTextension (total) 0.70 [0.12; 4.09] Thrombocytopenia 0.94 [0.52; 1.69] death at 3 months 0.50 [0.23; 1.08] |
| Trial | Treatments | Patients | Method |
|---|
| Cesarone, 2003 | Enoxaparin 100UL/Kg twice daily for 3 months (n=-9) vs. coumadin (target INR 3) for 3 months. (n=-9) | patients with cancer with DVT | NA Parallel groups Sample size: -9/-9 Primary endpoint: Death at 3 months FU duration: 3 months | | Deitcher, 2006 | Enoxaparin 1mg/kg twice daily for 5 days followed by 1-1.5mg/kg daily for 175 days (n=-9) vs. Enoxaparin 1mg/kg
twice daily for 5 days followed by warfarin (target INR 2-3) for a total of 180 days (n=-9) | patients with cancer with DVT and/or PE | none Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 months | | Meyer, 2002 | Enoxaparin 1.5 mg/kg daily for 3 monthsmag (n=-9) vs. Enoxaparin 1.5 mg/kg daily for 4 days followed by warfarin (target
INR 2-3) for 3 months (n=-9) | patients with cancer (solid or hematological; active or in remission but on treatment); with pulmonary embolism and/or DVT and a minimum life expectancy of 3 months | outcome assessment blinded Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 3 months |
|
| venous thrombosis | versus oral anticoagulant No demonstrated result for efficacy Enoxaparin inferior to coumarin in terms of VTE during active anticoagulant treatment in González-Fajardo, 2008 | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Pini, 1994 | Enoxaparin vs warfarin | | | VTE during follow-up after active anticoagulant treatment 2.56 [0.83; 7.85] VTE during active anticoagulant treatment 1.52 [0.44; 5.20] | | Gonzalez-Fajardo, 1999 | Enoxaparin vs warfarin | VTE during active anticoagulant treatment 0.42 [0.19; 0.90] | | | | Veiga, 2000 | Enoxaparin vs acenocoumarol | | | VTE during follow-up after active anticoagulant treatment 1.25 [0.41; 3.82] VTE during active anticoagulant treatment 2.00 [0.19; 21.36] | | Meyer, 2002 | Enoxaparin vs warfarin | | | VTE during follow-up after active anticoagulant treatment ∞ [NaN; ∞] | | Deitcher, 2003 | Enoxaparin vs warfarin | | | VTE during active anticoagulant treatment 0.59 [0.09; 3.96] | | González-Fajardo, 2008 | Enoxaparin vs coumarin | | VTE during active anticoagulant treatment 1.97 [1.06; 3.66] | |
| Trial | Treatments | Patients | Method |
|---|
| Pini, 1994 | UFH, APTT 1.3–1.9 followed by Enoxaparin 4,000 IU qd (n=93) vs. UFH, APTT 1.3–1.9 followed by Warfarin target INR 2-3.5 (n=94) | patients with objective diagnosis of DVT by Venography (diagnosed by strain-gauge plethysmography plus D-dimer latex assay and confirmed by venography) | open Sample size: 93/94 Primary endpoint: none defined FU duration: 9 mo | | Gonzalez-Fajardo, 1999 | LMWH, 4,000 IU bid followed by Enoxaparin 4,000 IU qd (n=93) vs. UFH followed by Warfarin target INR 2-3 (n=92) | patients with objective diagnosis of DVT by Venography | open Parallel groups Sample size: 93/92 Primary endpoint: none defined FU duration: 9 mo | | Veiga, 2000 | UFH, APTT 1.5–2.0d followed by Enoxaparin 4,000 IU qd (n=50) vs. UFH, APTT 1.5–2.0d followed by Acenocoumarol target INR 2-3 (n=50) | patients with objective diagnosis of DVT by Venography | open Sample size: 50/50 Primary endpoint: none defined FU duration: 6-9 mo | | Meyer, 2002 | LMWH, 1.5 mg/kg qd followed by Enoxaparin 1.5 mg/Kg qd (n=71) vs. LMWH, 1.5 mg/kg qd followed by Warfarin target INR 2-3 (n=58) | patients with cancer and objective diagnosis of DVT by Venography/compression ultrasonography | open Sample size: 71/58 Primary endpoint: major bleeding or recurrent venous thromboembolism FU duration: 3 mo | | Deitcher, 2003 | LMWH: 1a, 1 mg/kg q12h; 1b, 1 mg/kg qd12h followed by Enoxaparin 1a: 1 mg/kg qd; 1b: 1.5 mg/kg qd (n=51) vs. LMWH, 1 mg/kg q12h followed by Warfarin target INR 2-3 (n=30) | patients with objective diagnosis of DVT | open Sample size: 51/30 Primary endpoint: FU duration: 6 mo | | González-Fajardo, 2008 | long-term anticoagulant treatment with enoxaparin during at least 3 months (n=85) vs. long-term anticoagulant treatment with coumarin during at least 3 months (n=80) | patients with symptomatic, unilateral, first-episode DVT | open, blind assessment Parallel groups Sample size: 85/80 Primary endpoint: incidence of post-thrombotic syndrome FU duration: 1y, 5y |
|
| venous thrombosis | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Simonneau et al , 1993 | Enoxaparin vs unfractionated heparin | | | all cause death 1.50 [0.26; 8.69] Recurrent thromboembolic event 0.00 [0.00; NaN] Thrombus extension 0.14 [0.02; 1.13] Short term haemorrhage NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Simonneau et al , 1993 | Enoxaparin Subcutaneous twice daily for 0 Days, 100 U/kg BID (n=67) vs. unfractionated heparin intravenous APPTx1.5-2.5 (n=67) | | Sample size: 67/67 Primary endpoint: FU duration: 3 Months |
|
| venous thrombosis | versus twice daily LMWH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Merli, 2001 | once daily enoxaparin vs twice daily enoxaparin | | | Mortality 1.65 [0.65; 4.19] Haemorraghic events 1.31 [0.35; 4.83] Recurrent thromboembolic events 1.51 [0.66; 3.49] |
| Trial | Treatments | Patients | Method |
|---|
| Merli, 2001 | enoxaparin 1.5 mg/kg body weight
once daily (n=298) vs. S.c. enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily (n=312) | patients with a symptomatic lower-extremity DVT confirmed by venography or ultrasonography (including patients with confirmed PE) | double blind Parallel groups Sample size: 298/312 Primary endpoint: FU duration: |
|
| venous thrombosis | versus UFH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Merli (once daily vs UFH), 2001 | once daily enoxaparin vs UFH | | | Mortality 1.19 [0.50; 2.83] Haemorraghic events 1.15 [0.77; 1.70] Recurrent thromboembolic events 1.05 [0.49; 2.27] |
| Trial | Treatments | Patients | Method |
|---|
| Merli (once daily vs UFH), 2001 | Initial therapy with enoxaparin 1.5 mg/kg body weight
once daily
(n=298) vs. Initial therapy with dose-adjusted intravenous
unfractionated heparin (n=290)
| patients with a symptomatic lower-extremity DVT confirmed by venography or ultrasonography (including patients with confirmed PE)
| partialy blinded Parallel groups Sample size: 298/290 Primary endpoint: occurrence of symptomatic recurrent venous thromboembolism FU duration: 3 months
|
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