Bleeding rates for selected anticoagulants
| Agent . | Indication . | Incidence of major bleeding, % . | Reference . |
|---|---|---|---|
| UFH | VTE prophylaxis | 3.5 (69/1992) | Freedman et al (2000)19 |
| VTE treatment | 2.0 (17/748) | Mismetti et al (2005)20 | |
| ACS | 4.5 (386/8606) | Petersen et al (2004)21 | |
| LMWH | |||
| Enoxaparin | VTE prophylaxis | 1.7 (63/3621) | Turpie et al (2002)14 |
| VTE treatment | 2.1 (16/754) | Mismetti et al (2005)20 | |
| ACS | 4.7 (381/8044) | Petersen et al (2004)21 | |
| Dalteparin | VTE prophylaxis | 1.5 (15/983) | Hull et al (2000)22 |
| ACS | 3.3 (34/1049) | FRISC II Investigators (1999)23 | |
| Tinzaparin | VTE treatment | 2.0 (6/304) | Simonneau et al (1997)24 |
| Factor Xa inhibitor | |||
| Fondaparinux | VTE prophylaxis | 2.7 (96/3616) | Turpie et al (2002)14 |
| VTE treatment | 1.2 (12/1098) | Buller et al (2004)25 | |
| ACS | 2.2 (217/10,057) | Yusuf et al (2006)26 | |
| DTI | |||
| Lepirudinb | HIT | 18.8 (21/112) | Greinacher et al (2000)27 |
| Argatroban | HIT | 6.1 (14/229) | Lewis et al (2003)28 |
| Bivalirudin | ACS with PCI | 3.5c (82/2318) | Ebrahimi et al (2005)29 |
| Agent . | Indication . | Incidence of major bleeding, % . | Reference . |
|---|---|---|---|
| UFH | VTE prophylaxis | 3.5 (69/1992) | Freedman et al (2000)19 |
| VTE treatment | 2.0 (17/748) | Mismetti et al (2005)20 | |
| ACS | 4.5 (386/8606) | Petersen et al (2004)21 | |
| LMWH | |||
| Enoxaparin | VTE prophylaxis | 1.7 (63/3621) | Turpie et al (2002)14 |
| VTE treatment | 2.1 (16/754) | Mismetti et al (2005)20 | |
| ACS | 4.7 (381/8044) | Petersen et al (2004)21 | |
| Dalteparin | VTE prophylaxis | 1.5 (15/983) | Hull et al (2000)22 |
| ACS | 3.3 (34/1049) | FRISC II Investigators (1999)23 | |
| Tinzaparin | VTE treatment | 2.0 (6/304) | Simonneau et al (1997)24 |
| Factor Xa inhibitor | |||
| Fondaparinux | VTE prophylaxis | 2.7 (96/3616) | Turpie et al (2002)14 |
| VTE treatment | 1.2 (12/1098) | Buller et al (2004)25 | |
| ACS | 2.2 (217/10,057) | Yusuf et al (2006)26 | |
| DTI | |||
| Lepirudinb | HIT | 18.8 (21/112) | Greinacher et al (2000)27 |
| Argatroban | HIT | 6.1 (14/229) | Lewis et al (2003)28 |
| Bivalirudin | ACS with PCI | 3.5c (82/2318) | Ebrahimi et al (2005)29 |
UFH indicates unfractionated heparin; VTE, venous thromboembolism; ACS, acute coronary syndrome; LMWH, low-molecular-weight heparin; DTI, direct thrombin inhibitors; HIT, heparin-induced thrombocytopenia; PCI, percutaneous coronary intervention.
Bleeding rates were obtained from meta-analyses or pivotal clinical trials. A major bleed was most often defined as intracranial, fatal, retroperitoneal, intraocular, or needing surgical intervention, with or without the need for transfusion. Individual trials used different definitions of major bleeding.
The dosing regimen previously used in the approval trials for lepirudin for treatment of HIT is now considered too high,30-33 and currently dosing less than that stated in the package insert is recommended.34
Patients undergoing PCI are at additional risk for bleeding compared with patients treated with antithrombotic therapy alone.