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Lepirudin in patients with heparin-induced thrombocytopenia - results of the third prospective study (HAT-3) and a combined analysis of HAT-1, HAT-2, and HAT-3 Lubenow N; Eichler P; Lietz T; Greinacher AJ Thromb Haemost 2005[Nov]; 3 (11): 2428-36OBJECTIVES: To assess efficacy and safety of lepirudin in patients with heparin-induced thrombocytopenia (HIT) in a prospective study (HAT-3) as well as in a combined analysis of all HAT study data. PATIENTS/METHODS: Patients with laboratory-confirmed HIT were treated with lepirudin in three different aPTT-adjusted dose regimen and during cardiopulmonary bypass (CPB). Endpoints were new thromboembolic complications (TEC), limb amputations, and death and major bleeding. A historical control group (n = 120) was used for comparison. RESULTS: After start of lepirudin in 205 patients treated in HAT-3, the combined endpoint occurred in 43 (21.0%). Thirty (14.6%) patients died, 10 (4.9%) underwent limb amputation, and 11 (5.4%) new TECs occurred. Major bleeding occurred in 40 patients (19.5%) (seven during CPB surgery). Combining all prospective HAT trials (n = 403), after start of lepirudin treatment, the combined endpoint occurred in 82 patients (20.3%), with 47 deaths (11.7%), 22 limb amputations (5.5%), 30 new TECs (7.4%), and 71 (17.6%) major bleedings. Compared with the historical control group (log-rank test), the combined endpoint after start of treatment was reduced (29.7% vs. 52.1%, P = 0.0473), primarily because of reduction in new thromboses (11.9% vs. 32.1%, P = 0.0008). Mean lepirudin maintenance doses ranged from 0.07 to 0.11 mg kg(-1) h(-1). Major bleeding was more frequent in the lepirudin-treated patients (29.4% vs. 9.1%, P = 0.0148). CONCLUSIONS: The rate of new TECs in HIT patients is low after start of lepirudin treatment. The rate of major bleeding of 17.6% might be reduced by reducing the starting dose to 0.1 mg kg(-1) h(-1).|Adult[MESH]|Aged[MESH]|Aged, 80 and over[MESH]|Amputation, Surgical/statistics & numerical data[MESH]|Anticoagulants/adverse effects/*therapeutic use[MESH]|Female[MESH]|Hemorrhage/etiology[MESH]|Heparin/*adverse effects[MESH]|Hirudins/adverse effects/immunology[MESH]|Humans[MESH]|Male[MESH]|Middle Aged[MESH]|Prospective Studies[MESH]|Recombinant Proteins/adverse effects/immunology/therapeutic use[MESH]|Secondary Prevention[MESH]|Survival Analysis[MESH]|Thrombocytopenia/complications/*drug therapy/*etiology[MESH]|Thromboembolism/etiology/*prevention & control[MESH] |