Patient demographics and characteristics
| Characteristic . | Lepirudin (n = 113) . | Historical control (n = 91) . |
|---|---|---|
| Sex | ||
| Male | 41 (36%) | 32 (35%) |
| Female | 72 (64%) | 59 (65%) |
| Age (yrs) | ||
| Younger than 65 | 74 (65%) | 40 (44%) |
| 65 or older | 39 (35%) | 51 (56%) |
| Mean | 57 ± 15 | 64 ± 14 |
| Patient population | ||
| Internal medicine* | 56 (50%) | 27 (30%) |
| Orthopedic surgery | 23 (20%) | 34 (37%) |
| Traumatology | 12 (11%) | 19 (21%) |
| Cardiovascular surgery | 3 (3%) | 4 (4%) |
| Other surgical interventions | 13 (12%) | 6 (7%) |
| Other | 6 (5%) | 1 (1%) |
| TEC acquired during or after heparin/heparinoid therapy† | ||
| No. evaluable patients | 110 | 90 |
| No. with TEC | 85 (77.3%) | 80 (89%) |
| Type of TEC‡ | ||
| Venous-distal | 53 (62.4%) | 53 (66%) |
| Pulmonary embolism | 42 (49.4%) | 35 (44%) |
| Venous-proximal | 40 (47.8%) | 23 (29%) |
| Arterial-peripheral | 30 (35.3%) | 17 (21%) |
| Characteristic . | Lepirudin (n = 113) . | Historical control (n = 91) . |
|---|---|---|
| Sex | ||
| Male | 41 (36%) | 32 (35%) |
| Female | 72 (64%) | 59 (65%) |
| Age (yrs) | ||
| Younger than 65 | 74 (65%) | 40 (44%) |
| 65 or older | 39 (35%) | 51 (56%) |
| Mean | 57 ± 15 | 64 ± 14 |
| Patient population | ||
| Internal medicine* | 56 (50%) | 27 (30%) |
| Orthopedic surgery | 23 (20%) | 34 (37%) |
| Traumatology | 12 (11%) | 19 (21%) |
| Cardiovascular surgery | 3 (3%) | 4 (4%) |
| Other surgical interventions | 13 (12%) | 6 (7%) |
| Other | 6 (5%) | 1 (1%) |
| TEC acquired during or after heparin/heparinoid therapy† | ||
| No. evaluable patients | 110 | 90 |
| No. with TEC | 85 (77.3%) | 80 (89%) |
| Type of TEC‡ | ||
| Venous-distal | 53 (62.4%) | 53 (66%) |
| Pulmonary embolism | 42 (49.4%) | 35 (44%) |
| Venous-proximal | 40 (47.8%) | 23 (29%) |
| Arterial-peripheral | 30 (35.3%) | 17 (21%) |
Excluding patients with surgery.
All patients had ongoing TEC, but in 22.7% of the lepirudin-treated patients and in 11% of the historical control patients, TEC was the primary indication for heparin treatment.
Percentages refer to numbers of patients with TEC; patients might have had multiple TEC of multiple types.
HIT, heparin-induced thrombocytopenia; TEC, thromboembolic complication.