| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| acute coronary syndrome | dalteparin | not classified | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FRISC (long term), 1996 | dalteparin vs placebo (on top of aspirin) | myocardial infarction 0.70 [0.49; 0.99] | | long term MI or death 0.91 [0.71; 1.16] death 0.85 [0.46; 1.54] all revascularisations 0.78 [0.60; 1.01] myocardial infarction or death 0.75 [0.54; 1.03] | | FRIC prolonged treatment phase (LWMH vs PBO), 1997 | dalteparin vs placebo (on top of aspirin) | | | long term MI or death 1.05 [0.72; 1.51] death 1.61 [0.83; 3.13] all revascularisations 1.00 [0.79; 1.27] myocardial infarction 0.86 [0.56; 1.32] recurrent angina 1.12 [0.87; 1.45] myocardial infarction or death 1.05 [0.72; 1.51] | | FRISC (short term), 1996 | dalteparin vs placebo (on top of aspirin) | | | |
| Trial | Treatments | Patients | Method |
|---|
| FRISC (long term), 1996 | dalteparin SC 120 IU per kg bodyweight [maximum 10 000 IU] twice daily for 6 days with 7500 IU once daily for 34-45 days +aspirin (n=746) vs. matched placebo + aspirin (n=760) the primary aims was to compare the difference during the first 6 days between dalteparin and placebo | patients with unstable CAD (unstable angina or non-Q-wave myocardial infarction) within the previous 72 hours | double blind Parallel groups Sample size: 746/760 Primary endpoint: death or new myocardial infarction FU duration: 40 days | | FRIC prolonged treatment phase (LWMH vs PBO), 1997 | dalteparin SC 120 i.u./kg twice-daily for 6 days followed by dalteparin 7500UI daily up to day 45 (+aspirin) (n=731) vs. unfractionated heparin dose-adjusted intravenous infusion (for at least 48h) then by subcutaneous injection up to day 6 (then placebo) (+aspirin)
(n=751)
| Patients with unstable angina or non-Q-wave myocardial infarction
| double blind Parallel groups Sample size: 731/751 Primary endpoint: death MI recurrence of angina FU duration: 45 days the second phase is bliding but the first one is open. Perfommence biais is not discarded | | FRISC (short term), 1996 | dalteparin SC 120 IU per kg bodyweight [maximum 10 000 IU] twice daily for 6 days with 7500 IU once daily for 34-45 days +aspirin
(n=746) vs. matched placebo + aspirin
(n=760)
| patients with unstable CAD (unstable angina or non-Q-wave myocardial infarction) within the previous 72 hours
| double blind Sample size: 746/760 Primary endpoint: death or new myocardial infarction FU duration: 6 days
|
|
| acute coronary syndrome | dalteparin | not classified | versus UFH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FRIC (acute phase LMWH vs UFH), 1997 | dalteparin vs UFH (on top of aspirin) | | | death 3.57 [1.00; 12.74] all revascularisations 0.90 [0.58; 1.40] myocardial infarction 0.80 [0.44; 1.46] myocardial infarction or death 1.09 [0.65; 1.83] |
| Trial | Treatments | Patients | Method |
|---|
| FRIC (acute phase LMWH vs UFH), 1997 | twice-daily weight-adjusted subcutaneous injections of dalteparin (120 i.u./kg) (+aspirin)
(n=751) vs. dose-adjusted intravenous infusion of unfractionated heparin (+aspirin)
(n=731) | Patients with unstable angina or non-Q-wave myocardial infarction
| open Sample size: 751/731 Primary endpoint: FU duration: 6 days
|
|
| acute coronary syndrome | enoxaparin | not classified | 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 | enoxaparin | not classified | 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 | enoxaparin | not classified | 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 coronary syndrome | nadroparin | not classified | versus UFH No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FRAXIS (6days), 1998 | nadroparin vs UFH (on top of aspirin) | | | recurrent angina at 14 days 0.93 [0.76; 1.14] long term MI or death 1.10 [0.83; 1.44] death 1.06 [0.51; 2.18] all revascularisations 0.95 [0.67; 1.36] myocardial infarction 1.09 [0.66; 1.79] recurrent angina 0.84 [0.67; 1.06] death, myocardial infarction, or recurrent at 14 days 0.99 [0.83; 1.18] myocardial infarction or death 0.99 [0.63; 1.56] death at 30 days 1.18 [0.79; 1.77] myocardial infarction at 30 days 1.10 [0.79; 1.52] | | FRAXIS (14 days), 1998 | nadroparin vs UFH (on top of aspirin) | | | recurrent angina at 14 days 1.11 [0.92; 1.35] long term MI or death 1.15 [0.87; 1.50] death 1.26 [0.70; 2.29] all revascularisations 0.95 [0.78; 1.14] myocardial infarction 0.98 [0.64; 1.49] recurrent angina 1.11 [0.92; 1.35] myocardial infarction or death 1.08 [0.74; 1.56] |
| Trial | Treatments | Patients | Method |
|---|
| FRAXIS (6days), 1998 | nadroparin for 6 days (+aspirin) (n=1166) vs. unfractionated heparin for 6 days (+aspirin) (n=1151) | unstable angina or non-Q wave myocardial
infraction | Double blind Parallel groups Sample size: 1166/1151 Primary endpoint: death, MI, recurent or refractory angina FU duration: 14 days | | FRAXIS (14 days), 1998 | nadroparin for 14 days
(n=1151) vs. unfractionated heparin for 14 days
(n=1151)
| unstable angina or non-Q wave myocardial
infraction
| double blind Sample size: 1151/1151 Primary endpoint: death, MI, recurent or refractory angina FU duration: 14 days
|
|
| acute coronary syndrome | UFH | not classified | versus placebo or control No demonstrated result for efficacy | 10 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ATACS (Cohen), 1994 | UFH, warfarin vs control (on top of aspirin) | | | death 1.04 [0.15; 7.24] major bleeding 7.06 [0.41; 120.87] myocardial infarction 0.69 [0.26; 1.88] recurrent angina 0.62 [0.32; 1.21] myocardial infarction or death 0.46 [0.15; 1.45] | | Holdright, 1994 | UFH vs control (on top of aspirin) | | | major bleeding 0.85 [0.08; 8.71] myocardial infarction or death 0.89 [0.62; 1.29] | | Cohen (ATACS pilot) (heparin+aspirin vs asp), 1990 | UFH, warfarin vs control (on top of aspirin) | | | death NaN [NaN; NaN] all revascularisations 1.59 [0.94; 2.67] major bleeding NaN [NaN; NaN] minor bleeding 0.86 [0.06; 13.28] myocardial infarction 0.00 [0.00; NaN] recurrent angina 1.24 [0.81; 1.91] | | RISC (heparin+aspirin vs ASP), 1990 | UFH vs control (on top of aspirin) | | | myocardial infarction or death 0.80 [0.32; 2.03] | | Theroux (heparin+aspirin vs PBO), 1988 | UFH + aspirin vs placebo | myocardial infarction 0.14 [0.03; 0.59] recurrent angina 0.47 [0.25; 0.86] myocardial infarction or death 0.14 [0.03; 0.60] | | death 0.00 [0.00; NaN] | | Gurfinkel (UFH+aspririn vs aspirin), 1995 | UFH vs placebo (on top of aspirin) | | | death NaN [NaN; NaN] all revascularisations 0.81 [0.32; 2.06] major bleeding 5.21 [0.29; 92.25] minor bleeding ∞ [NaN; ∞] myocardial infarction 0.60 [0.18; 1.95] recurrent angina 1.20 [0.80; 1.78] myocardial infarction or death 0.60 [0.18; 1.95] | | Theroux (heparin vs PBO), 1988 | UFH vs placebo | death, MI and recurrence 0.35 [0.19; 0.67] myocardial infarction 0.07 [0.01; 0.53] recurrent angina 0.37 [0.19; 0.73] myocardial infarction or death 0.07 [0.01; 0.53] | | death 0.00 [0.00; NaN] major bleeding 1.00 [0.14; 6.98] minor bleeding 2.00 [0.62; 6.46] | | RISC (heparin vs PBO), 1990 | UFH vs placebo | | | myocardial infarction or death 0.90 [0.54; 1.48] | | Theroux (heparin+ASP vs ASP), 1988 | UFH vs control (on top of aspirin) | death, MI and recurrence 0.45 [0.25; 0.80] | | | | RISC (ASP+ heparin vs PBO), 1990 | UFH + aspirin vs placebo | myocardial infarction or death 0.24 [0.07; 0.83] | | |
| Trial | Treatments | Patients | Method |
|---|
| ATACS (Cohen), 1994 | aspirin 162.5 mg daily plus heparin (activated partial thromboplastin time, two times control) followed by aspirin 162.5 mg daily plus warfarin (international normalized ratio, 2 to 3) for 12 weeks. (n=105) vs. aspirin alone (162.5 mg daily) for 12 weeks. (n=109) | patients with unstable rest angina or non-Q-wave myocardial infarction with last episode of pain within 48 hours of randomization and who were nonprior aspirin users | single blind Parallel groups Sample size: 105/109 Primary endpoint: FU duration: 12 weeks | | Holdright, 1994 | intravenous heparin plus oral aspirin (150 mg once daily) (n=154) vs. aspirin alone 150 mg/d (n=131) | unstable angina | single blind Parallel groups Sample size: 154/131 Primary endpoint: FU duration: hospital stay | | Cohen (ATACS pilot) (heparin+aspirin vs asp), 1990 | aspirin (80 mg/day) plus heparin and then warfarin (n=37) vs. aspirin (325 mg/day) (n=32) | Patients between 21 and 75 years with unstable angina or non-Q-wave MI with last episode of pain within 48 hours of screening. | open Parallel groups Sample size: 37/32 Primary endpoint: FU duration: 12 weeks | | RISC (heparin+aspirin vs ASP), 1990 | 5 days of intermittent intravenous heparin + oral aspirin 75 mg/day (n=210) vs. oral aspirin 75 mg/day (n=189) | unstable angina or non-Q-wave myocardial infarction | open Parallel groups Sample size: 210/189 Primary endpoint: FU duration: 90 days | | Theroux (heparin+aspirin vs PBO), 1988 | heparin (1000 units per hour by intravenous infusion)+ aspirin (325 mg twice daily) (n=122) vs. aspirin (325 mg twice daily) (n=118) | | double blind Sample size: 122/118 Primary endpoint: FU duration: 3-9 days | | Gurfinkel (UFH+aspririn vs aspirin), 1995 | aspirin plus UFH 5000 IU iv then 400 IU/kg body weight per day intravenously and titered by activated partial thromboplastin time (n=70) vs. aspirin 200 mg/day (n=73) | patients greater than 21 years with ustable angina within 24 hours of randomizationcatio | double blind Parallel groups Sample size: 70/73 Primary endpoint: FU duration: 5-7 days | | Theroux (heparin vs PBO), 1988 | heparin (1000 units per hour by intravenous infusion) (n=118) vs. placebo (n=118) | patients with acute unstable angina pectoris | double blind Sample size: 118/118 Primary endpoint: FU duration: 3-9 days | | RISC (heparin vs PBO), 1990 | 5 days of intermittent intravenous heparin (n=198) vs. placebo (n=199) | men with unstable coronary artery disease (unstable angina or non-Q-wave myocardial infarction) | Factorial plan Sample size: 198/199 Primary endpoint: FU duration: 1y (5,30 and 90 days) | | Theroux (heparin+ASP vs ASP), 1988 | aspirin 325 mg/d + heparin 1000 UI/hr IV (n=122) vs. aspirin 325 mg/d (n=121) |
| double blind Sample size: 122/121 Primary endpoint: FU duration: 3-9 days
| | RISC (ASP+ heparin vs PBO), 1990 | oral apsirin 75mg/d + intermittent IV heparin 10000UI/d followed by 7500 UI 6-hourly for 4 days (n=210) vs. placebo
(n=199) | men with unstable coronary artery disease (unstable angina or non-Q-wave myocardial infarction) | Sample size: 210/199 Primary endpoint: FU duration: 1y (5,30 and 90 days)
|
|
| acute coronary syndrome | UFH | not classified | versus aspirin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Cohen (ATACS pilot) (heparin vs asp), 1990 | UFH, warfarin vs aspirin | | | death NaN [NaN; NaN] all revascularisations 1.33 [0.73; 2.43] major bleeding NaN [NaN; NaN] minor bleeding 0.00 [0.00; NaN] recurrent angina 0.83 [0.46; 1.50] myocardial infarction or death 4.00 [0.44; 36.12] |
| Trial | Treatments | Patients | Method |
|---|
| Cohen (ATACS pilot) (heparin vs asp), 1990 | heparin followed by warfarin (without aspirin) (n=24) vs. aspirin 325 mg/day (n=32) | Patients between 21 and 75 years with unstable angina or non-Q-wave MI with last episode of pain within 48 hours of screening | open Parallel groups Sample size: 24/32 Primary endpoint: FU duration: 12 weeks |
|
| acute myocardial infarction | enoxaparin | not classified | versus heparin No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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] |
| Trial | Treatments | Patients | Method |
|---|
| 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 |
|
| acute myocardial infarction | UFH | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ECSG, 1992 | UFH vs placebo | | | death in hospital 0.81 [0.34; 1.92] reinfarction during hospitalization 0.99 [0.42; 2.34] | | DUCCS, 1994 | UFH vs no heparin | | | death in hospital 1.43 [0.61; 3.38] reinfarction during hospitalization 2.14 [0.68; 6.78] |
| Trial | Treatments | Patients | Method |
|---|
| ECSG, 1992 | UFH 5000 IU bolus, UFH 1000 IU/h for 48–120 h (n=324) vs. Placebo (n=320) | patients treated with alteplase thrombolysis for acute myocardial infarction, Age 21–70 y STEMI <=6h | Double-blind Parallel groups Sample size: 324/320 Primary endpoint: Angiographic patency FU duration: In-hospital | | DUCCS, 1994 | UFH no bolus, 15 IU/kg per h for 4 d; target aPTT 50–90 s (n=128) vs. No heparin (n=122) | patients with acute myocardial infarction four hours after APSAC administration, age <=85 y STEMI <=12 h | open Parallel groups Sample size: 128/122 Primary endpoint: Death, recurrent MI, recurrent ischemia, angiographic patency FU duration: 14 d |
|
| thrombosis prevention | ardeparin | abdominal surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ardeparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Godwin, 1993 | Ardeparin 90 and 50 units/kg b.i.d (n=595) vs. UFH 10 000 units (n=309) | Abdominopelvic surgery | Blind Sample size: 595/309 Primary endpoint: FU duration: |
|
| thrombosis prevention | ardeparin | knee surgery | versus placebo or no treatment No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Levine, 1996 | ardeparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Levine, 1996 | ardeparin 50/kgx2 +elastic stockings (n=122) vs. Placebo+elastic stockings (n=124) | Knee | double blind Sample size: 122/124 Primary endpoint: FU duration: 14 days |
|
| thrombosis prevention | Certoparin | abdominal surgery | versus No demonstrated result for efficacy | 12 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Schmitz-Huebner, 1984 | certoparin vs unfractionated heparin | | | major haemorrhage ∞ [NaN; ∞] clinical PE NaN [NaN; NaN] asymptomatic DVT ∞ [NaN; ∞] wound hematoma 2.13 [0.61; 7.41] symptomatic thromboembolism NaN [NaN; NaN] | | Sasahara, 1986 | certoparin vs unfractionated heparin | transfusion 0.59 [0.35; 0.99] | | death 0.39 [0.08; 1.95] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 1.01 [0.50; 2.07] wound hematoma 1.33 [0.23; 7.74] | | Voigt, 1986 | certoparin vs unfractionated heparin | | | death 0.63 [0.18; 2.16] total haemorrhage 0.51 [0.20; 1.34] major haemorrhage 2.83 [0.30; 26.70] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 0.94 [0.06; 14.85] wound hematoma 0.30 [0.06; 1.47] symptomatic thromboembolism 0.00 [0.00; NaN] transfusion 0.91 [0.71; 1.16] | | Welzel, 1988 | certoparin vs unfractionated heparin | asymptomatic DVT 0.30 [0.10; 0.88] | | wound hematoma 1.50 [0.31; 7.19] | | Kakkar, 1989 | certoparin vs unfractionated heparin | | | total haemorrhage 2.07 [0.53; 8.01] major haemorrhage ∞ [NaN; ∞] clinical PE ∞ [NaN; ∞] asymptomatic DVT 0.83 [0.34; 2.00] wound hematoma 2.00 [0.15; 26.19] | | Adolf, 1989 | certoparin vs unfractionated heparin | | | clinical PE 3.00 [0.26; 34.58] asymptomatic DVT 1.50 [0.54; 4.14] wound hematoma 0.74 [0.23; 2.33] transfusion 1.31 [0.95; 1.81] | | Baumgartner, 1989 | certoparin vs unfractionated heparin | | | death 0.52 [0.05; 5.59] major haemorrhage NaN [NaN; NaN] clinical PE 1.00 [0.05; 18.57] asymptomatic DVT 0.88 [0.31; 2.50] wound hematoma ∞ [NaN; ∞] | | Hoffmann and Largiade, 1990 | certoparin vs unfractionated heparin | | | major haemorrhage 0.97 [0.44; 2.15] clinical PE ∞ [NaN; ∞] | | certoparin vs unfractionated heparin | | | | | certoparin vs unfractionated heparin | | | | | certoparin vs unfractionated heparin | | | | | certoparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Schmitz-Huebner, 1984 | Certoparin (dose 1 and dose 2) b.i.d. (n=84) vs. UFH 10 000 units (n=42) | Abdominal surgery | Blind Sample size: 84/42 Primary endpoint: FU duration: 1 month | | Sasahara, 1986 | Certoparin 3000 + DHE (n=137) vs. UFH 10 000 units +DHE (n=132) | Abdominal surgery | Blind Sample size: 137/132 Primary endpoint: FU duration: 7 days | | Voigt, 1986 | Certoparin 3000 + DHE (n=103) vs. UFH 10 000 units (n=97) | Abdominal surgery | Blind Sample size: 103/97 Primary endpoint: FU duration: 10 days | | Welzel, 1988 | Certoparin 2500 + DHE (n=98) vs. UFH 10 000 units+DHE (n=103) | Abdominal surgery | Open Sample size: 98/103 Primary endpoint: FU duration: 7 days | | Kakkar, 1989 | Certoparin 3000 + DHE (n=88) vs. UFH 10 000 units+DHE (n=91) | Abdominal surgery | Blind Sample size: 88/91 Primary endpoint: FU duration: | | Adolf, 1989 | Certoparin 3000 (n=205) vs. UFH 15 000 units (n=205) | Abdominal surgery | Blind Sample size: 205/205 Primary endpoint: FU duration: 1 month | | Baumgartner, 1989 | Certoparin 3000 + DHE (n=99) vs. UFH 5 000 units+DHE (n=102) | Abdominal surgery | Blind Sample size: 99/102 Primary endpoint: FU duration: 10 days | | Hoffmann and Largiade, 1990 | Certoparin 3000 + DHE (n=464) vs. UFH 10 000 units (n=452) | Abdominal surgery | NA Sample size: 464/452 Primary endpoint: FU duration: | | Koppenhagen, 1990 | Certoparin 3000 anti Xa units (n=51) vs. UFH 15 000 units (n=53) | Abdominal surgery | Blind Sample size: 51/53 Primary endpoint: FU duration: | | Schielke, 1991 | Certoparin 3000 anti Xa units + DHE (n=47) vs. UFH 10 000 units + DHE (n=51) | Abdominal surgery | Open Sample size: 47/51 Primary endpoint: FU duration: | | Koppenhagen, 1992 | Certoparin 3000 anti Xa units (n=336) vs. UFH 15 000 units (n=337) | Abdominal surgery | Blind Sample size: 336/337 Primary endpoint: FU duration: | | Hoffmann and Largiader, 1992 | Certoparin 3000 anti Xa units (n=298) vs. UFH 10 000 units (n=296) | Abdominothoracic surgery | Blind Sample size: 298/296 Primary endpoint: FU duration: |
|
| thrombosis prevention | Certoparin | general surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| certoparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Haas, 1999 | Certoparin 3000 anti Xa units (n=11542) vs. UFH 15 000 units (n=11536) | General surgery | Blind Sample size: 11542/11536 Primary endpoint: FU duration: |
|
| thrombosis prevention | Certoparin | gynaecological surgery | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Heilmann, 1989 | certoparin vs unfractionated heparin | | | major haemorrhage 0.67 [0.11; 3.93] clinical PE NaN [NaN; NaN] asymptomatic DVT 0.33 [0.07; 1.63] wound hematoma 0.70 [0.24; 2.10] | | certoparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Heilmann, 1989 | Certoparin 3000 (n=150) vs. UFH 15 000 units (n=150) | Gynaecological surgery | Blind Sample size: 150/150 Primary endpoint: FU duration: 10 days | | Heilmann, 1997 | Certoparin 3000 anti Xa units (n=179) vs. UFH 15 000 units (n=179) | Gynaecological and breast surgery | Blind Sample size: 179/179 Primary endpoint: FU duration: |
|
| thrombosis prevention | Certoparin | hip surgery | versus Unfractionated heparin No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Haas , 1987 | certoparine + DHE vs Unfractionated heparin | | | | | Lassen, 1988 | certoparine + DHE vs Unfractionated heparin | | | | | Lassen, 1989 | certoparine + DHE vs Unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Haas , 1987 | Sandoz +0.5mg DHE (n=80) vs. Unfractionated heparin (n=80) | Elective hip | Sample size: 80/80 Primary endpoint: FU duration: | | Lassen, 1988 | certoparin 3000+0.5mg DHE, x1 (n=118) vs. Placebo (n=122) | Elective hip | double blind Sample size: 118/122 Primary endpoint: FU duration: 6 days | | Lassen, 1989 | certoparin 3000+0.5mg DHE x1 (n=68) vs. placebo (n=71) | Hip fracture | double blind Sample size: 68/71 Primary endpoint: FU duration: 6 days |
|
| thrombosis prevention | dalteparin | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Ockelford , 1989 | dalteparin vs placebo | Asymptomatic Deep vein thrombosis 0.26 [0.09; 0.77] | | all cause death 0.00 [0.00; NaN] total bleeding 2.33 [0.76; 7.17] major Bleeding 0.93 [0.24; 3.62] Pulmonary embolism 0.00 [0.00; NaN] wound hematoma ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| Ockelford , 1989 | Dalteparin 2500 anti-Xa units (n=102) vs. Placebo (n=95) | general surgery | Blind Sample size: 102/95 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | abdominal surgery | versus No demonstrated result for efficacy dalteparin inferior to unfractionated heparin in terms of total haemorrhage in Bergqvist, 1986 (abdominal surgery patients) dalteparin inferior to unfractionated heparin in terms of transfusion in Bergqvist, 1986 (abdominal surgery patients) dalteparin inferior to unfractionated heparin in terms of total haemorrhage in Koller, 1986 (abdominal surgery patients) dalteparin inferior to unfractionated heparin in terms of total haemorrhage in Bergqvist, 1988 (abdominal surgery patients) | 9 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bergqvist, 1986 | dalteparin vs unfractionated heparin | | total haemorrhage 2.52 [1.24; 5.13] transfusion 1.38 [1.03; 1.84] | major haemorrhage 3.36 [0.94; 12.06] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 1.46 [0.64; 3.34] wound hematoma 1.86 [0.50; 6.84] | | Onarheim, 1986 | dalteparin vs unfractionated heparin | | | death NaN [NaN; NaN] total haemorrhage 0.54 [0.05; 5.59] major haemorrhage 1.08 [0.07; 16.36] clinical PE NaN [NaN; NaN] asymptomatic DVT ∞ [NaN; ∞] wound hematoma 0.00 [0.00; NaN] | | Koller, 1986 | dalteparin vs unfractionated heparin | | total haemorrhage 4.78 [1.20; 19.06] | death NaN [NaN; NaN] major haemorrhage 2.61 [0.59; 11.50] wound hematoma 3.50 [0.57; 21.67] transfusion 4.35 [0.55; 34.17] | | Koller, 1986 | dalteparin vs unfractionated heparin | | | death NaN [NaN; NaN] total haemorrhage 1.00 [0.46; 2.16] major haemorrhage ∞ [NaN; ∞] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 1.94 [0.18; 20.93] wound hematoma 1.50 [0.20; 11.24] transfusion 0.80 [0.22; 2.86] | | Fricker, 1988 | dalteparin vs unfractionated heparin | | | total haemorrhage 0.62 [0.29; 1.32] major haemorrhage 2.00 [0.19; 21.19] clinical PE 0.00 [0.00; NaN] asymptomatic DVT NaN [NaN; NaN] symptomatic thromboembolism 0.20 [0.02; 1.64] | | Bergqvist, 1988 | dalteparin vs unfractionated heparin | | total haemorrhage 1.97 [1.07; 3.61] | death 0.98 [0.41; 2.34] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 0.67 [0.42; 1.07] wound hematoma 2.50 [0.77; 8.13] transfusion 1.02 [0.89; 1.17] | | Caen, 1988 | dalteparin vs unfractionated heparin | | | death 0.65 [0.11; 3.84] total haemorrhage 0.97 [0.25; 3.84] major haemorrhage 0.00 [0.00; NaN] clinical PE 0.00 [0.00; NaN] asymptomatic DVT 0.84 [0.29; 2.44] wound hematoma 1.33 [0.23; 7.74] transfusion 1.34 [0.55; 3.26] | | Hartl, 1990 | dalteparin vs unfractionated heparin | transfusion 0.22 [0.05; 0.99] | | death 1.48 [0.43; 5.10] total haemorrhage 0.98 [0.25; 3.85] major haemorrhage 0.66 [0.11; 3.86] clinical PE 1.00 [0.05; 18.57] asymptomatic DVT 1.03 [0.31; 3.45] wound hematoma 1.00 [0.05; 18.57] | | dalteparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Bergqvist, 1986 | Dalteparin 5000 (n=215) vs. UFH 10 000 units (n=217) | Abdominal surgery | Blind Sample size: 215/217 Primary endpoint: FU duration: 1 month | | Onarheim, 1986 | Dalteparin 5000 (n=25) vs. UFH 10 000 units (n=27) | Abdominal surgery | Blind Sample size: 25/27 Primary endpoint: FU duration: 1 month | | Koller, 1986 | Dalteparin 7500 (n=23) vs. UFH 10 000 units (n=20) | Abdominal surgery | Blind Sample size: 23/20 Primary endpoint: FU duration: 30 days | | Koller, 1986 | Dalteparin 2500 (n=75) vs. UFH 10 000 units (n=75) | Abdominal surgery | Blind Sample size: 75/75 Primary endpoint: FU duration: 30 days | | Fricker, 1988 | Dalteparin 5000 (n=40) vs. UFH 15 000 units (n=40) | Abdominopelvic surgery | Open Sample size: 40/40 Primary endpoint: FU duration: 1-2 months | | Bergqvist, 1988 | Dalteparin 5000 (n=505) vs. UFH 10 000 units (n=497) | Abdominal surgery | Blind Sample size: 505/497 Primary endpoint: FU duration: 1 month | | Caen, 1988 | Dalteparin 2500 (n=195) vs. UFH 10 000 units (n=190) | Abdominal surgery | Blind Sample size: 195/190 Primary endpoint: FU duration: 1 month | | Hartl, 1990 | Dalteparin 2500 (n=126) vs. UFH 10 000 units (n=124) | Abdominal surgery | Blind Sample size: 126/124 Primary endpoint: FU duration: > 7 days | | Kakkar, 1993 | Dalteparin 2500 anti Xa units (n=1894) vs. UFH 10 000 units (n=1915) | Abdominal surgery | Blind Sample size: 1894/1915 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | general surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Creperio, 1990 | dalteparin vs unfractionated heparin | | | clinical PE NaN [NaN; NaN] asymptomatic DVT 1.67 [0.46; 6.06] symptomatic thromboembolism NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Creperio, 1990 | Dalteparin 2500 (n=20) vs. UFH 10 000 units (n=20) | General surgery | Blind Sample size: 20/20 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | gynaecological surgery | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Borstad, 1988 | dalteparin vs unfractionated heparin | | | total haemorrhage 1.16 [0.91; 1.49] major haemorrhage 1.05 [0.07; 16.53] clinical PE NaN [NaN; NaN] asymptomatic DVT NaN [NaN; NaN] wound hematoma 1.73 [0.56; 5.32] symptomatic thromboembolism NaN [NaN; NaN] | | dalteparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Borstad, 1988 | Dalteparin 5000 (n=105) vs. UFH 10 000 units (n=110) | Gynaecological surgery | Blind Sample size: 105/110 Primary endpoint: FU duration: | | Borstad, 1992 | Dalteparin 2500 anti Xa units (n=77) vs. UFH 10 000 units (n=75) | Gynaecological surgery | Blind Sample size: 77/75 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | hip surgery | versus placebo or no treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Jorgensen, 1989 | dalteparin vs placebo | | | | | Torholm, 1991 | dalteparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Jorgensen, 1989 | dalteparin 5000 x1 (n=30) vs. Placebo (n=38) | Hip fracture | double blind Sample size: 30/38 Primary endpoint: FU duration: 9 days | | Torholm, 1991 | dalteparin 5000x1 (n=58) vs. Placebo (n=54) | Elective hip | double blind Sample size: 58/54 Primary endpoint: FU duration: 9 days |
|
| thrombosis prevention | dalteparin | hip surgery | versus Dextran No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Eriksson , 1988 | dalteparin vs Dextran | | | | | Matzsch , 1988 | dalteparin vs Dextran | | | | | Matzsch , 1991 | dalteparin vs Dextran | | | |
| Trial | Treatments | Patients | Method |
|---|
| Eriksson , 1988 | dalteparin (n=50) vs. Dextran (n=50) | Elective hip | Sample size: 50/50 Primary endpoint: FU duration: | | Matzsch , 1988 | dalteparin (n=48) vs. Dextran (n=52) | Elective hip | Sample size: 48/52 Primary endpoint: FU duration: | | Matzsch , 1991 | dalteparin (n=120) vs. Dextran (n=123) | Elective hip | Sample size: 120/123 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | hip surgery | versus Unfractionated heparin No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Haas , 1985 | dalteparin vs Unfractionated heparin | | | | | Binsack , 1986 | dalteparin vs Unfractionated heparin | | | | | Barre , 1987 | dalteparin vs Unfractionated heparin | | | | | Dechavanne , 1989 | dalteparin vs Unfractionated heparin | | | | | Eriksson , 1989 | dalteparin vs Unfractionated heparin | | | | | Monreal , 1989 | dalteparin vs Unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Haas , 1985 | dalteparin (n=65) vs. Unfractionated heparin (n=65) | Elective hip | Sample size: 65/65 Primary endpoint: FU duration: | | Binsack , 1986 | dalteparin (n=48) vs. Unfractionated heparin (n=47) | Elective hip | Sample size: 48/47 Primary endpoint: FU duration: | | Barre , 1987 | dalteparin (n=40) vs. Unfractionated heparin (n=40) | Elective hip | Sample size: 40/40 Primary endpoint: FU duration: | | Dechavanne , 1989 | dalteparin (n=82) vs. Unfractionated heparin (n=40) | Elective hip | Sample size: 82/40 Primary endpoint: FU duration: | | Eriksson , 1989 | dalteparin (n=67) vs. Unfractionated heparin (n=69) | Elective hip | Sample size: 67/69 Primary endpoint: FU duration: | | Monreal , 1989 | dalteparin (n=46) vs. Unfractionated heparin (n=44) | Hip | Sample size: 46/44 Primary endpoint: FU duration: |
|
| thrombosis prevention | dalteparin | non orthopedic surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Briel, 1988 | dalteparin vs unfractionated heparin | | | asymptomatic DVT 1.03 [0.07; 16.26] wound hematoma 1.50 [0.20; 11.24] |
| Trial | Treatments | Patients | Method |
|---|
| Briel, 1988 | Dalteparin 5000 (n=95) vs. UFH 10 000 units+DHE (n=98) | Gynaecological surgery | NA Sample size: 95/98 Primary endpoint: FU duration: |
|
| thrombosis prevention | enoxaparin | not classified | versus placebo or control No demonstrated result for efficacy enoxaparin inferior to no treatment in terms of total bleeding in Ho [43] | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| 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] |
| Trial | Treatments | Patients | Method |
|---|
| 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 |
|
| thrombosis prevention | enoxaparin | abdominal surgery | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | | | enoxaparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| 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: |
|
| thrombosis prevention | enoxaparin | general surgery | versus No demonstrated result for efficacy | 5 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 | | | |
| 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 | | 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: |
|
| thrombosis prevention | enoxaparin | gynaecological surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| enoxaparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| 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: |
|
| thrombosis prevention | enoxaparin | hip surgery | versus placebo or no treatment No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Turpie, 1986 | 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 | | 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 | enoxaparin | hip surgery | 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 | enoxaparin | hip surgery | 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: |
|
| thrombosis prevention | enoxaparin | knee surgery | versus placebo or no treatment No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Leclerc, 1991 | enoxaparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Leclerc, 1991 | Enoxaparin 3000 x2 (n=65) vs. Placebo (n=64) | Knee | double blind Sample size: 65/64 Primary endpoint: FU duration: 14 days |
|
| thrombosis prevention | fraxiparin | not classified | versus placebo or control No demonstrated result for efficacy nadroparin inferior to placebo in terms of total bleeding in Pezzuoli, 1989 nadroparin inferior to placebo in terms of major Bleeding in Pezzuoli, 1989 nadroparin inferior to placebo in terms of wound hematoma in Pezzuoli, 1989 nadroparin inferior to placebo in terms of transfusin in Pezzuoli, 1989 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Pezzuoli, 1989 | nadroparin vs placebo | symptomatic thromboembolism event 0.29 [0.11; 0.80] | total bleeding 2.09 [1.80; 2.44] major Bleeding 2.51 [1.91; 3.30] wound hematoma 1.88 [1.55; 2.29] transfusin 1.65 [1.34; 2.03] | all cause death 0.45 [0.19; 1.02] Pulmonary embolism 0.25 [0.05; 1.18] |
| Trial | Treatments | Patients | Method |
|---|
| Pezzuoli, 1989 | Nadroparin 2850 anti-Xa units (n=2247) vs. Placebo (n=2251) | general surgery | Blind Sample size: 2247/2251 Primary endpoint: FU duration: |
|
| thrombosis prevention | fraxiparin | hip surgery | versus Unfractionated heparin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Leyvraz, 1991 | nadroparin vs Unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Leyvraz, 1991 | Fraxiparin (n=203) vs. Unfractionated heparin (n=206) | Elective hip | Sample size: 203/206 Primary endpoint: FU duration: |
|
| thrombosis prevention | nadroparin | not classified | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Balas [40] | nadroparin vs placebo | | | total bleeding 0.58 [0.17; 1.91] | | Marassi [41] | nadroparin vs no treatment | | | total bleeding 0.00 [0.00; NaN] wound hematoma 0.00 [0.00; NaN] transfusin 1.15 [0.65; 2.04] | | Nurmohamed, 1996 | nadroparin vs placebo | | | thromboembolic events (symptomatic or asymptomatic) 0.71 [0.48; 1.06] proxymal DVT 0.60 [0.30; 1.18] |
| Trial | Treatments | Patients | Method |
|---|
| Balas [40] | Nadroparin 2850 anti-Xa units (n=94) vs. Placebo (n=95) | | Blind Sample size: 94/95 Primary endpoint: FU duration: | | Marassi [41] | Nadroparin 2850 anti-Xa units (n=31) vs. No treatment (n=33) | | Open Sample size: 31/33 Primary endpoint: FU duration: | | Nurmohamed, 1996 | Nadroparin, 7500 Institute Choay anti-Xa units per day subcutaneously 18-24 hours postoperatively plus compression for 10 days (n=241) vs. compression stockings + placebo (n=244) | Craniotomy or spinal surgery for tumor or injury, 18 years or older, without excess bleeding risk | Sample size: 241/244 Primary endpoint: FU duration: 56 days |
|
| thrombosis prevention | nadroparin | abdominal surgery | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EFS, 1988 | nadroparin vs unfractionated heparin | symptomatic thromboembolism 0.27 [0.07; 0.95] | | death 0.89 [0.40; 2.01] total haemorrhage 0.99 [0.82; 1.19] clinical PE 0.20 [0.02; 2.07] asymptomatic DVT 0.63 [0.39; 1.01] wound hematoma 0.97 [0.37; 2.55] transfusion 1.01 [0.82; 1.25] | | nadroparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| EFS, 1988 | Nadroparin 2850 (n=968) vs. UFH 15 000 units (n=941) | Abdominal surgery | Open Sample size: 968/941 Primary endpoint: FU duration: 1 month | | Eurin, 1994 | Nadroparin 2850 anti Xa units (n=241) vs. UFH 15 000 units (n=239) | Abdominopelvic surgery | Open Sample size: 241/239 Primary endpoint: FU duration: |
|
| thrombosis prevention | nadroparin | general surgery | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Kakkar and Murray, 1985 | nadroparin vs unfractionated heparin | asymptomatic DVT 0.36 [0.13; 0.99] | | death 0.83 [0.26; 2.69] clinical PE 0.00 [0.00; NaN] wound hematoma 0.79 [0.23; 2.65] symptomatic thromboembolism 0.00 [0.00; NaN] transfusion 1.14 [0.85; 1.53] | | nadroparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Kakkar and Murray, 1985 | Nadroparin 2850 (n=200) vs. UFH 10 000 units (n=200) | General surgery | Blind Sample size: 200/200 Primary endpoint: FU duration: 10 days | | Barbui, 1990 | Nadroparin 2850 anti Xa units (n=171) vs. UFH 10 000 units (n=173) | General surgery | Open Sample size: 171/173 Primary endpoint: FU duration: |
|
| thrombosis prevention | nadroparin | hip surgery | versus placebo or no treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Yoo, 1997 | nadroparin vs no treatment | | | | | Sourmelis, 1995 | nadroparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Yoo, 1997 | nadroparin 41/kgx1 days 1-3, 62/kg x1 days 4-11+elastic stockings (n=50) vs. no treatment (n=50) | Elective hip | open Sample size: 50/50 Primary endpoint: FU duration: 10 days | | Sourmelis, 1995 | nadroparin 3075x1 preop, 6150x1 post op (n=72) vs. Placebo (n=78) | Hip fracture | double blind Sample size: 72/78 Primary endpoint: FU duration: 10-12 days |
|
| thrombosis prevention | nadroparin | thoracic surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Dahan, 1989 | nadroparin vs unfractionated heparin | | | clinical PE NaN [NaN; NaN] asymptomatic DVT NaN [NaN; NaN] wound hematoma 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Dahan, 1989 | Nadroparin 2850 (n=46) vs. UFH 15 000 units (n=41) | Thoracic surgery | Open Sample size: 46/41 Primary endpoint: FU duration: |
|
| thrombosis prevention | reviparin | general surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| reviparin vs unfractionated heparin | | | |
| 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: |
|
| thrombosis prevention | tinzaparin | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bergqvist [42] | tinzaparin vs placebo | | | all cause death 0.00 [0.00; NaN] total bleeding ∞ [NaN; ∞] major Bleeding ∞ [NaN; ∞] Pulmonary embolism 0.00 [0.00; NaN] Asymptomatic Deep vein thrombosis 0.35 [0.10; 1.20] wound hematoma NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Bergqvist [42] | Tinzaparin 3500 anti-Xa units (n=39) vs. Placebo (n=41) | | Blind Parallel groups Sample size: 39/41 Primary endpoint: FU duration: |
|
| thrombosis prevention | tinzaparin | abdominal surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| tinzaparin vs unfractionated heparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| Leizorovicz, 1991 | Tinzaparin 2500 and 3500 anti Xa units (n=861) vs. UFH 10 000 units (n=429) | Abdominothoracic and gynaecological surgery | Blind Sample size: 861/429 Primary endpoint: FU duration: |
|
| thrombosis prevention | tinzaparin | hip surgery | versus placebo or no treatment No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Lassen, 1991 | tinzaparin vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Lassen, 1991 | tinzaparin 50/kg x1 +elastic stockings (n=105) vs. Placebo+elastic stockings (n=105) | Elective hip | double blind Sample size: 105/105 Primary endpoint: FU duration: 8-10 days |
|
| thrombosis prevention | UFH | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Cerrato, 1978 | UFH vs no treatment | thromboembolic events (symptomatic or asymptomatic) 0.18 [0.06; 0.56] | | |
| Trial | Treatments | Patients | Method |
|---|
| Cerrato, 1978 | Unfractionated heparin, 5000 IU subcutaneously 3 times a day, starting 2 hours preoperatively for +7 days (n=50) vs. no treatment (n=50) | Elective neurosurgery for tumors, 40 years or older | Sample size: 50/50 Primary endpoint: FU duration: NA |
|
| venous thrombosis | Bemiparin | not classified | versus oral anticoagulant No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Kakkar, 2003 | Bemiparin vs warfarin | | | VTE during active anticoagulant treatment 0.78 [0.19; 3.19] |
| Trial | Treatments | Patients | Method |
|---|
| Kakkar, 2003 | LMWH, 115 IU/kg qd followed by Bemiparin 3,500 IU qd (n=221) vs. A: UFH, 30/40,000IU qd; B: LMWH, 115 IU/kg qd followed by Warfarin target INR 2-3 (n=103) | patients with objective diagnosis of DVT by Venography/compression ultrasonography | open Sample size: 221/103 Primary endpoint: none defined FU duration: 3 mo |
|
| venous thrombosis | dalteparin | not classified | versus oral anticoagulant No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Das, 1996 | Dalteparin vs warfarin | | | VTE during active anticoagulant treatment 2.75 [0.56; 13.55] | | Lee, 2003 | Dalteparin vs warfarin | VTE during active anticoagulant treatment 0.51 [0.33; 0.79] | | |
| Trial | Treatments | Patients | Method |
|---|
| Das, 1996 | UFH followed by Dalteparin 5,000 IU qd (n=50) vs. UFH followed by Warfarin target INR 2-3 (n=55) | patients with objective diagnosis of DVT by Venography | open Sample size: 50/55 Primary endpoint: recurrent venous thromboembolism FU duration: 3 mo | | Lee, 2003 | LMWH, 200 IU/kg qd followed by Dalteparin 150 IU/kg qd (n=336) vs. LMWH, 200 IU/kg qd followed by Warfarin target INR 2-3 (n=336) | patients with cancer and objective diagnosis of DVT by Venography/compression ultrasonography | open Sample size: 336/336 Primary endpoint: recurrent thrombosis FU duration: 6 mo |
|
| venous thrombosis | dalteparin | not classified | versus No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bratt et al , 1985 | Dalteparin vs unfractionated heparin | | | all cause death NaN [NaN; NaN] Recurrent thromboembolic event NaN [NaN; NaN] Thrombus extension 0.00 [0.00; NaN] Short term haemorrhage ∞ [NaN; ∞] | | Holm et al , 1986 | Dalteparin vs unfractionated heparin | | | all cause death NaN [NaN; NaN] Recurrent thromboembolic event ∞ [NaN; ∞] Thrombus extension 0.47 [0.04; 4.85] Short term haemorrhage NaN [NaN; NaN] | | Bratt et al, 1990 | Dalteparin vs unfractionated heparin | | | all cause death 1.83 [0.72; 4.64] Recurrent thromboembolic event 0.67 [0.20; 2.24] Thrombus extension 0.67 [0.12; 3.85] Short term haemorrhage 0.00 [0.00; NaN] | | Lindmarker et al , 1993 | Dalteparin vs unfractionated heparin | | | all cause death 0.68 [0.12; 3.98] Recurrent thromboembolic event 2.04 [0.52; 7.93] Thrombus extension 0.73 [0.24; 2.22] Short term haemorrhage NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Bratt et al , 1985 | Dalteparin Intravenousv (ajusted) for >=5 Days, 120 U/kg BID (n=25) vs. unfractionated heparin intravenous APPTx1.7-3.5 (n=29) | | Sample size: 25/29 Primary endpoint: FU duration: 23 Months (mean) | | Holm et al , 1986 | Dalteparin Subcutaneous twice daily ajusted for 7 Days, 57-107 U/kg BID (n=29) vs. unfractionated heparin subcutaneous twice daily 16000-30000 U (n=27) | | Sample size: 29/27 Primary endpoint: FU duration: Hospital Stay | | Bratt et al, 1990 | Dalteparin Subcutaneous twice daily ajusted for >= 5 Days, 120 U/kg BID (n=60) vs. unfractionated heparin intravenous APPTx2-4 (n=60) | | Sample size: 60/60 Primary endpoint: FU duration: Hospital stay | | Lindmarker et al , 1993 | Dalteparin Subcutaneous once daily for >= 5 Days, 200 U/kg BID (n=101) vs. unfractionated heparin intravenous APPTx1.5-3 (n=103) | | Sample size: 101/103 Primary endpoint: FU duration: 6 Months |
|
| venous thrombosis | dalteparin | not classified | versus twice daily LMWH No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Holmström, 1992 | once daily dalteparin vs twice daily dalteparin | | | Improvement of thrombus size 1.07 [0.72; 1.59] Haemorraghic events 0.00 [0.00; NaN] | | Partsch, 1996 | once daily dalteparin vs twice daily dalteparin | | | Mortality 2.53 [0.27; 23.70] Haemorraghic events ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| Holmström, 1992 | once daily dalteparin 200 U (anti-FXa)/kg for at least 5 days (n=50) vs. twice daily dalteparin 100
U (anti-FXa)/kg for at least 5 days (n=51) | Patients with a first occurence of DVT in the lower limb, confirmed with phlebographytio | open Parallel groups Sample size: 50/51 Primary endpoint: FU duration: | | Partsch, 1996 | Fragmin administered 200 IU/kg once daily for at least 7 days (n=76) vs. Fragmin 100 IU/kg twice daily for at least 7 days (n=64) | patients presented with DVT extending into the iliofemoral segment diagnosed by duplex ultrasonographyA | NA Parallel groups Sample size: 76/64 Primary endpoint: FU duration: |
|
| venous thrombosis | enoxaparin | not classified | 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 | enoxaparin | not classified | 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 | enoxaparin | not classified | 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 | enoxaparin | not classified | 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
|
|
| venous thrombosis | heparin | not classified | versus No demonstrated result for efficacy subcutaneous heparin inferior to intravenous heparin in terms of extension or recurrence of VTE in Hull, 1986 | 8 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Krahenbuhl, 1979 | subcutaneous heparin vs intravenous heparin | | | | | Bentley, 1980 | subcutaneous heparin vs intravenous heparin | extension or recurrence of VTE 0.10 [0.01; 0.75] | | major hemorrhage 0.25 [0.03; 2.16] | | Andersson, 1982 | subcutaneous heparin vs intravenous heparin | | | | | Hull, 1986 | subcutaneous heparin vs intravenous heparin | | extension or recurrence of VTE 3.73 [1.10; 12.68] | major hemorrhage 1.02 [0.15; 6.98] | | Doyle, 1987 | subcutaneous heparin vs intravenous heparin | | | major hemorrhage 2.04 [0.39; 10.65] extension or recurrence of VTE 1.02 [0.31; 3.31] | | Walker, 1987 | subcutaneous heparin vs intravenous heparin | extension or recurrence of VTE 0.15 [0.04; 0.65] | | major hemorrhage 1.00 [0.15; 6.82] | | Lopaciuk | subcutaneous heparin vs intravenous heparin | | | major hemorrhage 1.92 [0.18; 20.43] extension or recurrence of VTE 0.27 [0.06; 1.25] | | Pini, 1990 | subcutaneous heparin vs intravenous heparin | | | major hemorrhage 0.54 [0.18; 1.56] extension or recurrence of VTE 1.93 [0.36; 10.35] |
| Trial | Treatments | Patients | Method |
|---|
| Krahenbuhl, 1979 | subcutaneous sodic heparin 30 000 U daily (mean) (n=23) vs. intravenous sodic heparin 30 000 U daily (mean) (n=25) | | Sample size: 23/25 Primary endpoint: FU duration: | | Bentley, 1980 | subcutaneous calcic heparin 37 000 U daily (mean) (n=50) vs. intravenous sodic heparin 36 800 U daily (mean) (n=50) | | Sample size: 50/50 Primary endpoint: FU duration: | | Andersson, 1982 | subcutaneous sodic heparin 36 800 U daily (mean) (n=72) vs. intravenous sodic heparin 33 250 U daily (mean) (n=69) | | Sample size: 72/69 Primary endpoint: FU duration: | | Hull, 1986 | subcutaneous sodic heparin 32 300 U daily (mean) (n=57) vs. intravenous sodic heparin 29 700 U daily (mean) (n=58) | | Sample size: 57/58 Primary endpoint: FU duration: | | Doyle, 1987 | subcutaneous calcic heparin 29 200 U daily (mean) (n=51) vs. intravenous calcic heparin 29 600 U daily (mean) (n=52) | | Sample size: 51/52 Primary endpoint: FU duration: | | Walker, 1987 | subcutaneous calcic heparin 29 375 U daily (mean) (n=50) vs. intravenous calcic heparin 24 384 U daily (mean) (n=50) | | Sample size: 50/50 Primary endpoint: FU duration: | | Lopaciuk | subcutaneous sodic heparin 34 400 U daily (mean) (n=48) vs. intravenous sodic heparin 37 000 U daily (mean) (n=46) | | Sample size: 48/46 Primary endpoint: FU duration: | | Pini, 1990 | subcutaneous calcic heparin 33 800 U daily (mean) (n=138) vs. intravenous sodic heparin 31 700 U daily (mean) (n=133) | | Sample size: 138/133 Primary endpoint: FU duration: |
|
| venous thrombosis | logiparin | not classified | versus twice daily LMWH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Siegbahn, 1989 | once daily logiparin vs twice daily logiparin | | | Improvement of thrombus size 2.00 [0.68; 5.85] Mortality NaN [NaN; NaN] Haemorraghic events NaN [NaN; NaN] Recurrent thromboembolic events NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Siegbahn, 1989 | Once daily logiparin 150 XaI U/kgp, imag (n=10) vs. twice daily logiparin 75 XaI U/kg (n=10) | patients with a venographically confirmed episode of DVT | single blind Parallel groups Sample size: 10/10 Primary endpoint: FU duration: |
|
| venous thrombosis | nadroparin | not classified | versus oral anticoagulant No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Lopaciuk, 1999 | Nadroparin vs acenocoumarol | | | VTE during follow-up after active anticoagulant treatment 2.53 [0.50; 12.71] VTE during active anticoagulant treatment 0.43 [0.11; 1.61] | | Lopez-Beret, 2001 | Nadroparin vs acenocoumarol | | | VTE during follow-up after active anticoagulant treatment 0.50 [0.09; 2.65] VTE during active anticoagulant treatment 2.85 [0.80; 10.14] |
| Trial | Treatments | Patients | Method |
|---|
| Lopaciuk, 1999 | LMWH, 85 UI/kg bid followed by Nadroparin 85 IU/kg qd (n=101) vs. LMWH, 85 UI/kg bid followed by Acenocoumarol target INR 2-3 (n=101) | patients with objective diagnosis of DVT by Venography | open Sample size: 101/101 Primary endpoint: none defined FU duration: 9 mo | | Lopez-Beret, 2001 | LMWH, 1,025 IU/10 kg bid followed by Nadroparin 1,025 IU/10 kg bid (n=81) vs. LMWH, 1,025 IU/10 kg bid followed by Acenocoumarol target INR 2-3 (n=77) | patients with objective diagnosis of DVT by compression ultrasonography | open Sample size: 81/77 Primary endpoint: none defined FU duration: 6-9 mo |
|
| venous thrombosis | nadroparin | not classified | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Collaborative European Multicentre, 1991 | Nadroparin vs unfractionated heparin | | | all cause death 1.89 [0.18; 20.31] Recurrent thromboembolic event 2.83 [0.30; 26.52] Thrombus extension 0.47 [0.09; 2.49] Short term haemorrhage 1.89 [0.36; 9.95] | | Prandoni et al , 1992 | Nadroparin vs unfractionated heparin | Thrombus extension 0.36 [0.13; 0.95] | | all cause death 0.50 [0.20; 1.27] Recurrent thromboembolic event 0.50 [0.20; 1.27] Short term haemorrhage 0.33 [0.04; 3.14] | | Lopaciuk et al , 1992 | Nadroparin vs unfractionated heparin | | | all cause death 0.00 [0.00; NaN] Recurrent thromboembolic event 0.00 [0.00; NaN] Thrombus extension 0.84 [0.39; 1.83] Short term haemorrhage 0.00 [0.00; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| Collaborative European Multicentre, 1991 | Nadroparin Subcutaneous twice daily for 10 Days, 90 U/kg BID (n=70) vs. unfractionated heparin intravenous APPTx1.5-2 (n=66) | | Sample size: 70/66 Primary endpoint: FU duration: 12 Weeks | | Prandoni et al , 1992 | Nadroparin Subcutaneous twice daily for >=0 Days, 90 U/kg BID (n=85) vs. unfractionated heparin intravenous APPTx1.5-2 (n=85) | | Sample size: 85/85 Primary endpoint: FU duration: 6 Months | | Lopaciuk et al , 1992 | Nadroparin Subcutaneous twice daily for 10 Days, 92 U/kg BID (n=74) vs. unfractionated heparin subcutaneous twice daily APPTx1.5-2.5 (n=75) | | Sample size: 74/75 Primary endpoint: FU duration: 3 Months |
|
| venous thrombosis | nadroparin | not classified | versus twice daily LMWH No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Charbonnier, 1998 | once daily nadroparin vs twice daily nadroparin | | | Mortality 0.73 [0.32; 1.69] Haemorraghic events 0.62 [0.29; 1.34] Recurrent thromboembolic events 0.57 [0.30; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| Charbonnier, 1998 | Once daily nadroparin 20,500 (AXa IU/ml)continued for at least 5 days (n=316) vs. twice daily
nadroparin 10,250 (AXa IU/ml)continued for at least 5 days (n=335) | patients with acute symptomatic proximal DVT in popliteal vein or above
documented by venography | double blind Parallel groups Sample size: 316/335 Primary endpoint: FU duration: |
|
| venous thrombosis | tinzaparin | not classified | versus oral anticoagulant No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hull, 2002 | Tinzaparin vs warfarin | | | VTE during follow-up after active anticoagulant treatment 1.00 [0.50; 2.01] VTE during active anticoagulant treatment 0.76 [0.40; 1.43] | | Romera, 2009 | Tinzaparin vs acenocoumarol | DVT (recurrent) 0.21 [0.05; 0.92] | | bleeding 0.34 [0.04; 3.24] VTE at the end of trial 0.47 [0.19; 1.20] VTE during follow-up after active anticoagulant treatment 0.17 [0.02; 1.40] VTE during active anticoagulant treatment 0.73 [0.24; 2.24] PE 1.37 [0.31; 5.98] |
| Trial | Treatments | Patients | Method |
|---|
| Hull, 2002 | LMWH, 175 IU/kg qd followed by Tinzaparin 175 IU/kg qd (n=369) vs. UFH 5 d, followed by UFH therapeutic APTT followed by Warfarin target INR 2-3 (n=368) | patients with objective diagnosis of DVT by Venography/compression ultrasonography | open Sample size: 369/368 Primary endpoint: FU duration: 9 mo | | Romera, 2009 | tinzaparin SC 175 IU anti-Xa per kg once daily for 6 months (n=119) vs. acenocoumarol for target INR 2-3 for 6 months after initial LMWH (until INR 2-3) (n=122) | patients with symptomatic proximal DVT of the lowerlimbs confirmed by compression duplex ultrasound scan | open Parallel groups Sample size: 119/122 Primary endpoint: symptomatic recurrent venous thromboembolism FU duration: 12 months |
|
| venous thrombosis | tinzaparin | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hull et al , 1992 | Tinzaparin vs unfractionated heparin | Short term haemorrhage 0.09 [0.01; 0.72] | | all cause death 0.49 [0.24; 1.02] Recurrent thromboembolic event 0.41 [0.16; 1.04] |
| Trial | Treatments | Patients | Method |
|---|
| Hull et al , 1992 | Tinzaparin Subcutaneous once daily for >= Days, 175 U/kg BID (n=213) vs. unfractionated heparin intravenous APPTx2-3 (n=219) | | Sample size: 213/219 Primary endpoint: FU duration: 3 Months |
|
| venous thrombosis | warfarin | not classified | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Schulman, 1995 | 6 months vs 1.5 months | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.05 [0.01; 0.19] Incidence of recurrent VTE 0.52 [0.37; 0.74] | | Mortality 0.75 [0.41; 1.40] Incidence of major bleeding 4.88 [0.57; 41.60] | | Pinede, 2001 | 3-6 months vs 1.5-3 months | | | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.17 [0.02; 1.43] Mortality 1.32 [0.61; 2.87] Incidence of major bleeding 1.73 [0.64; 4.71] Incidence of recurrent VTE 1.17 [0.68; 2.02] | | ELAET (Kearon), 2004 | warfarin vs discontinuation | | | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.52 [0.05; 5.61] Incidence of major bleeding (period after cessation of study medication until end of follow-up) NaN [NaN; NaN] Mortality (period after cessation of study medication until end of follow-up) NaN [NaN; NaN] Mortality ∞ [NaN; ∞] Incidence of major bleeding NaN [NaN; NaN] Incidence of recurrent VTE 0.62 [0.15; 2.52] |
| Trial | Treatments | Patients | Method |
|---|
| Schulman, 1995 | 6 months treatment with warfarin or dicoumarol adjusted for a target INR between 2.0 - 2.85 (n=-9) vs. 1.5 months warfarin or dicoumarol adjusted for a target INR between 2.0 - 2.85 (n=-9) | | open Parallel groups Sample size: -9/-9 Primary endpoint: recurrent VTE, major bleeding, death FU duration: Two years after randomization | | Pinede, 2001 | Long course of therapy (6 months for proximal DVT and/or PE; 12 weeks for calf DVT) by fluindione adjusted for INR range of 2.0 to 3.0 (n=-9) vs. Short oral anticoagulant course (3 months for proximal DVT and/or PE; 6 weeks for isolated calf
DVT) by fluindione adjusted for INR range of 2.0 to 3.0 (n=-9) randomization at the end of heparin therapy | | open Parallel groups Sample size: -9/-9 Primary endpoint: Recurrent VTE FU duration: 15 months after randomizationÛ | | ELAET (Kearon), 2004 | continuation for 2 additionnal months of warfarin adjusted to achieve
a target INR between 2.0 and 3.0. (n=-9) vs. discontinuation (after 1 months) (n=-9) | | double blind Parallel groups Sample size: -9/-9 Primary endpoint: recurrent VTE FU duration: 11 months (after randomizatio) |
|
| venous thrombosis | warfarin | not classified | versus discontinuation No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Levine, 1995 | warfarin vs discontinuation | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.11 [0.01; 0.83] | | Incidence of major bleeding (period after cessation of study medication until end of follow-up) ∞ [NaN; ∞] Mortality (period after cessation of study medication until end of follow-up) 0.96 [0.40; 2.33] Mortality 0.96 [0.40; 2.33] Incidence of major bleeding ∞ [NaN; ∞] Incidence of recurrent VTE 0.56 [0.23; 1.37] | | LAFIT (Kearon), 1999 | warfarin vs discontinuation | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.06 [0.01; 0.45] Incidence of recurrent VTE 0.06 [0.01; 0.45] | | Incidence of major bleeding (period after cessation of study medication until end of follow-up) ∞ [NaN; ∞] Mortality (period after cessation of study medication until end of follow-up) 0.35 [0.04; 3.30] Mortality 0.35 [0.04; 3.30] Incidence of major bleeding ∞ [NaN; ∞] | | Agnelli, 2001 | warfarin vs discontinuation | | | DVT 0.88 [0.47; 1.66] Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.36 [0.12; 1.11] Incidence of major bleeding (period after cessation of study medication until end of follow-up) 3.97 [0.45; 35.06] Mortality 0.99 [0.36; 2.75] Incidence of major bleeding 1.99 [0.37; 10.65] PE (with or without DVT) 1.65 [0.40; 6.78] Incidence of recurrent VTE 0.99 [0.57; 1.73] | | Agnelli, 2003 | warfarin vs discontinuation | | | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.16 [0.02; 1.34] Mortality 1.67 [0.68; 4.14] Incidence of major bleeding 2.93 [0.31; 27.85] Incidence of recurrent VTE 0.81 [0.42; 1.56] | | PREVENT (Ridker), 2003 | warfarin vs discontinuation | Incidence of recurrent VTE 0.38 [0.21; 0.68] | | Mortality 0.50 [0.15; 1.63] Incidence of major bleeding 2.48 [0.49; 12.67] | | DURAC (Schulman), 1997 | warfarin vs discontinuation | Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.12 [0.04; 0.40] Incidence of recurrent VTE 0.12 [0.04; 0.40] | | Mortality 0.60 [0.28; 1.26] Incidence of major bleeding 3.19 [0.90; 11.29] |
| Trial | Treatments | Patients | Method |
|---|
| Levine, 1995 | continuation for 2 months of warfarin adjusted INR value of 2.0 to 3.0 (n=-9) vs. Discontinue oral anticoagulant therapy (after 1 months) (n=-9) | Patients with venographically confirmed acute proximal DVT who had received four weeks of warfarin after initial heparin and whose four week IPG was normal | double blind Parallel groups Sample size: -9/-9 Primary endpoint: RecurrentDVT or PE andmajor bleeding FU duration: 11 months after randomization. | | LAFIT (Kearon), 1999 | Continuation of the oral anticoagulant therapy up to 24 months,
warfarin was adjusted to achieve
a target INR between 2.0 and 3.0. (n=-9) vs. discontinuation (after 3 months) (n=-9) | patients who had completed 3 months of anticoagulant therapy for a first episode of idiopathic venous thromboembolism | Sample size: -9/-9 Primary endpoint: FU duration: | | Agnelli, 2001 | continuation for 9 additional months; warfarin or acenocoumarol adjusted to achieve a target INR between 2.0 and 3.0 (n=-9) vs. discontinuation (after 3 months months) (n=-9) | Patients with a first episode of idiopathic proximal deep venous thrombosis who had completed three months of oral anticoagulant therapy | open Parallel groups Sample size: -9/-9 Primary endpoint: Recurrent VTE FU duration: 33 months | | Agnelli, 2003 | continuation for 3 or 9 additionnal months of warfarin or other oral anticoagulant was adjusted to achieve a target INR between 2.0 and 3.0. (n=-9) vs. discontinuation (after 3 months) (n=-9) | patients who had had 3 months of oral anticoagulant therapy without experiencing recurrence or bleeding after a first episode of pulmonary embolism | open Parallel groups Sample size: -9/-9 Primary endpoint: Recurrence of symptomatic confirmed VTE./pj FU duration: 33 months | | PREVENT (Ridker), 2003 | extension with low-intensity warfarin (target INR, 1.5 to 2.0) (n=255) vs. placebo (n=253) | Patients with idiopathic venous thromboembolism who had received full-dose anticoagulation therapy for a median of 6.5 months | Parallel groups Sample size: 255/253 Primary endpoint: FU duration: 2.1 years | | DURAC (Schulman), 1997 | indefinite warfarin or dicoumarol adjusted for a target INR between 2.0 and 2.85 (n=-9) vs. 6 months warfarin or dicoumarol adjusted for a target INR between 2.0 and 2.85 (n=-9) | | open Parallel groups Sample size: -9/-9 Primary endpoint: recurrent VTE, death, major bleeding FU duration: Four years after randomization |
|
