Predictive factors for major bleeding in patients with HIT treated with lepirudin
. | Major bleeding . | . | Multivariate analysis . | . | . | |||
|---|---|---|---|---|---|---|---|---|
. | Yes . | No . | Odds ratio . | 95% CI . | P . | |||
| Moderate to severe renal impairment, no. patients/no. total* | 19/27 (70.4) | 51/120 (42.5) | 13.20 | 3.53-49.10 | <.001 | |||
| Duration of lepirudin treatment, median, d (Q1-Q3) | 8.2 (2.9-17.9) | 7.5 (3.7-12.9) | 1.10† | 1.04-1.15 | .001 | |||
| Mean lepirudin dose, no. patients/no. total | ||||||||
| 0.04 mg/kg/h or less | 8/30 (26.7) | 41/133 (30.8) | 1.00 | NA | NA | |||
| 0.04-0.07 mg/kg/h | 5/30 (16.7) | 38/133 (28.6) | 1.33 | 0.31-5.71 | NA | |||
| More than 0.07 mg/kg/h | 17/30 (56.7) | 54/133 (40.6) | 11.01 | 2.46-49.3 | .003 | |||
. | Major bleeding . | . | Multivariate analysis . | . | . | |||
|---|---|---|---|---|---|---|---|---|
. | Yes . | No . | Odds ratio . | 95% CI . | P . | |||
| Moderate to severe renal impairment, no. patients/no. total* | 19/27 (70.4) | 51/120 (42.5) | 13.20 | 3.53-49.10 | <.001 | |||
| Duration of lepirudin treatment, median, d (Q1-Q3) | 8.2 (2.9-17.9) | 7.5 (3.7-12.9) | 1.10† | 1.04-1.15 | .001 | |||
| Mean lepirudin dose, no. patients/no. total | ||||||||
| 0.04 mg/kg/h or less | 8/30 (26.7) | 41/133 (30.8) | 1.00 | NA | NA | |||
| 0.04-0.07 mg/kg/h | 5/30 (16.7) | 38/133 (28.6) | 1.33 | 0.31-5.71 | NA | |||
| More than 0.07 mg/kg/h | 17/30 (56.7) | 54/133 (40.6) | 11.01 | 2.46-49.3 | .003 | |||
Mean aPTT (univariate analysis) was not a significant predictive factor for major bleeding. Compared with an odds ratio value of 1 in patients with a mean aPTT between 2 and 2.5 times baseline value, the odds ratio (95% CI) for major bleeding was 0.96 (0.39-2.33; P = .343) in patients with a mean aPTT greater than 2.5 times baseline value. Similarly, the administration of a bolus of lepirudin (multivariate analysis) was not a significant predictive factor for major bleeding. Compared with an odds ratio value of 1 in patients receiving no bolus of lepirudin, the odds ratio (95% CI) for major bleeding was 1.53 (0.49-4.78; P = .464) in patients receiving a bolus of lepirudin
NA indicates not applicable
Renal function assessed immediately before lepirudin treatment; moderate to severe renal impairment was defined by creatinine clearance lower than 60 mL/min
Per day