Clinical trials of enoxaparin - TrialResults-center.org

pathology

Benefit (demonstrated or suggested) and harm

acute coronary syndrome

All results are NS for efficacy

inferior to UFH (on top of aspirin) in terms of minor bleeding in ESSENCE, 1997

inferior to UFH (on top of aspirin) in terms of minor bleeding in TIMI 11 B (short term), 1998

inferior to UFH (on top of aspirin) in terms of major bleeding in SYNERGY, 2005

inferior to UFH (on top of aspirin) in terms of minor bleeding in INTERACT, 2006

inferior to UFH (on top of aspirin) in terms of major bleeding in TIMI 11 B (long term), 1998

inferior to UFH (on top of aspirin) in terms of minor bleeding in TIMI 11 B (long term), 1998

meta-analysis

Trial	control	p<0.05	harm	NS
ESSENCE, 1997	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	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	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	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]
EVET, 2005	vs UFH (on top of aspirin)	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]
TIMI 11 B (long term), 1998	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]
RESCUE	vs UFH (on top of aspirin)

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)
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
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
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 myocardial infarction

All results are NS for efficacy

meta-analysis

Trial	control	p<0.05	NS
ASSENT 3, 2001	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	vs UFH		reinfarction at 30 days 1.00 [0.38; 2.61] death at 30 dayas 0.90 [0.37; 2.17]
Baird, 2002	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	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	vs UFH		death at 30 dayas 1.25 [0.87; 1.80]
AMI-SK, 2002	vs UFH

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
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

heart failure

All results are NS for efficacy

meta-analysis

percutaneous coronary intervention

All results are NS for efficacy

meta-analysis

Trial	control	NS
STEEPLE, 2006	vs UFH
Rabah, 1999	vs UFH	safety criteria 1.00 [0.07; 15.26] Ischaemic complication 1.00 [0.22; 4.56]
CRUISE, 2003	vs UFH	safety criteria 0.00 [0.00; NaN] Ischaemic complication 1.13 [0.50; 2.56]
Galeote, 2001	vs UFH	safety criteria 0.25 [0.03; 2.12] Ischaemic complication 1.63 [0.41; 6.47]
Dudek, 2000	vs UFH	safety criteria NaN [NaN; NaN] Ischaemic complication 1.25 [0.50; 3.10]
Dudek b (enox alone), 2000	vs UFH
Drozd, 2001	vs UFH	safety criteria NaN [NaN; NaN] Ischaemic complication 1.00 [0.21; 4.72]
Dubek b (+abciximal), 2001	vs UFH
ATOLL, 2010	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

All results are NS for efficacy

meta-analysis

superficial thrombophlebitis

All results are NS for efficacy

meta-analysis

thrombosis prevention

All results are NS for efficacy

inferior to placebo in terms of total bleeding in Ho [43]

meta-analysis

Trial	control	p<0.05	harm	NS
LeGagneux , 1987	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]
Turpie, 1986	vs placebo	Deep vein thrombosis 0.29 [0.13; 0.65] asymptomatic proximal DVT 0.20 [0.05; 0.87]		all cause death 0.00 [0.00; NaN] Bleeding 0.50 [0.05; 5.34] Pulmonary embolism NaN [NaN; NaN]
Leclerc, 1991	vs placebo	Deep vein thrombosis 0.29 [0.16; 0.52]		Bleeding 0.79 [0.22; 2.80] asymptomatic proximal DVT 0.00 [0.00; NaN]
DES Group , 1991	vs placebo	Deep vein thrombosis 0.31 [0.14; 0.68]		all cause death ∞ [NaN; ∞] Pulmonary embolism NaN [NaN; NaN]
Planes , 1988	vs placebo	Deep vein thrombosis 0.51 [0.28; 0.90]		all cause death NaN [NaN; NaN] Bleeding ∞ [NaN; ∞] Pulmonary embolism 0.00 [0.00; NaN]
Levine , 1991	vs placebo			all cause death NaN [NaN; NaN] Bleeding 0.58 [0.28; 1.19] Pulmonary embolism 0.00 [0.00; NaN] Deep vein thrombosis 0.90 [0.65; 1.25]
Samama, 1997	vs placebo	asymptomatic proximal DVT 0.16 [0.04; 0.69]
Kalodiki, 1996	vs placebo
Warwick, 1995	vs placebo			asymptomatic proximal DVT 0.86 [0.42; 1.73]
MEDENOX, 1999	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	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]	vs placebo		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]
Samama 1, 1988	vs placebo			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	vs placebo			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	vs placebo			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]
	vs placebo
	vs placebo
	vs placebo
	vs placebo
	vs placebo
	vs placebo
Bergqvist, 1996	vs placebo	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	vs placebo			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	vs placebo	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]
Agnelli, 1998	vs placebo	thromboembolic events (symptomatic or asymptomatic) 0.51 [0.33; 0.80] proxymal DVT 0.39 [0.17; 0.90]
Melon, 1987	vs placebo			thromboembolic events (symptomatic or asymptomatic) 0.65 [0.31; 1.34]
Canata, 2003	vs placebo			minor bleeding 1.50 [0.28; 7.93] VTE (symptomatic or asymptomatic) NaN [NaN; NaN]
Bergmann and Neuhart, 1996	vs placebo			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	vs placebo			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	vs placebo			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]
LIFENOX, 2011	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
LeGagneux , 1987	Enoxaparin 6000 anti-Xa units (n=44) vs. Placebo (n=45)	prostatectomy surgery	Blind Sample size: 44/45 Primary endpoint: FU duration:
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
DES Group , 1991	Enoxaparin (n=120) vs. Dextran (n=126)	Elective hip	Sample size: 120/126 Primary endpoint: FU duration:
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:
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
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:
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:
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
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
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

venous thrombosis

All results are NS for efficacy

inferior to unfractionated heparin in terms of VTE during active anticoagulant treatment in González-Fajardo, 2008

meta-analysis

Trial	control	p<0.05	harm	NS
Simonneau et al , 1993	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]
Merli, 2001	vs unfractionated heparin			Mortality 1.65 [0.65; 4.19] Haemorraghic events 1.31 [0.35; 4.83] Recurrent thromboembolic events 1.51 [0.66; 3.49]
Cesarone, 2003	vs unfractionated heparin			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	vs unfractionated heparin			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	vs unfractionated heparin			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]
Merli (once daily vs UFH), 2001	vs unfractionated heparin			Mortality 1.19 [0.50; 2.83] Haemorraghic events 1.15 [0.77; 1.70] Recurrent thromboembolic events 1.05 [0.49; 2.27]
Pini, 1994	vs unfractionated heparin			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	vs unfractionated heparin	VTE during active anticoagulant treatment 0.42 [0.19; 0.90]
Veiga, 2000	vs unfractionated heparin			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	vs unfractionated heparin			VTE during follow-up after active anticoagulant treatment ∞ [NaN; ∞]
Deitcher, 2003	vs unfractionated heparin			VTE during active anticoagulant treatment 0.59 [0.09; 3.96]
González-Fajardo, 2008	vs unfractionated heparin		VTE during active anticoagulant treatment 1.97 [1.06; 3.66]

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
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:
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
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
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

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