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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

  1. N. LUBENOW,
  2. P. EICHLER,
  3. T. LIETZ,
  4. A. GREINACHER,
  5. THE HIT INVESTIGATORS GROUP

Article first published online: 14 OCT 2005

DOI: 10.1111/j.1538-7836.2005.01623.x

Issue

Journal of Thrombosis and Haemostasis

Journal of Thrombosis and Haemostasis

Volume 3, Issue 11, pages 2428–2436, November 2005

Additional Information

How to Cite

LUBENOW, N., EICHLER, P., LIETZ, T., GREINACHER, A. and THE HIT INVESTIGATORS GROUP (2005), 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. Journal of Thrombosis and Haemostasis, 3: 2428–2436. doi: 10.1111/j.1538-7836.2005.01623.x

Author Information

  1. Department of Immunology and Transfusion Medicine, Ernst-Moritz-Arndt University Greifswald, Greifswald, Germany

*Prof. Dr. Andreas Greinacher, Ernst-Moritz-Arndt Universität, Institut für Immunologie und Transfusionsmedizin, Klinikum/Sauerbruchstrasse, 17489 Greifswald, Germany. Tel.: +49 (0) 3834 865482; fax: +49 (0) 3834 865489; e-mail: greinach@uni-greifswald.de

Publication History

  1. Issue published online: 14 OCT 2005
  2. Article first published online: 14 OCT 2005
  3. Received 17 December 2004, accepted 5 August 2005

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Keywords:

  • heparin;
  • hirudin;
  • lepirudin;
  • thrombocytopenia;
  • thrombosis

Summary. Objectives: 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.

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