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Blood, Vol. 96 No. 3 (August 1), 2000:
pp. 846-851
Heparin-induced thrombocytopenia with thromboembolic
complications: meta-analysis of 2 prospective trials to assess the
value of parenteral treatment with lepirudin and its
therapeutic aPTT range
Andreas Greinacher,
Petra Eichler,
Norbert Lubenow,
Harald Kwasny, and
Matthias Luz
From the Institute for Immunology and Transfusion Medicine,
Ernst-Moritz-Arndt University Greifswald; the Biometrics Department,
Aventis-Behring, Marburg; and the Clinical Operations Department,
Aventis Pharma, Frankfurt, Germany.
This meta-analysis focuses on 2 prospective studies in patients with
heparin-induced thrombocytopenia (HIT) and thromboembolic complication
(TEC) who were treated with lepirudin (n = 113). Data were compared
with those of a historical control group (n = 91). The primary
endpoint (combined incidence of death, new TEC, and limb
amputation) occurred in 25 lepirudin-treated patients (22.1%; 95% CI,
14.5%-29.8%): 11 died (9.7%; 95% CI, 4.9%-16.8%), 7 underwent
limb amputation (6.2%; 95% CI, 2.5%-12.3%), and 12 experienced new
TEC (10.6%; 95% CI, 5.8%-18.3%). The risk was highest in the period
between diagnosis of HIT and the start of lepirudin therapy (combined
event rate per patient day 6.1%). It markedly decreased to 1.3%
during lepirudin treatment and to 0.7% in the posttreatment period.
From the start of lepirudin therapy to the end of follow-up,
lepirudin-treated patients had consistently lower incidences of the
combined endpoint than the historical control group (P = .004, log-rank test), primarily because of a reduced risk for new
TEC (P = .005). Thrombin-antithrombin levels in the
pretreatment period (median, 43.9 µg/L) decreased after the
initiation of lepirudin (at 24 hours ± 6 hours; median, 9.18 µg/L.)
During treatment with lepirudin, aPTT ratios of 1.5 to 2.5 produced
optimal clinical efficacy with a moderate risk for bleeding, aPTT
ratios lower than 1.5 were subtherapeutic, and aPTT levels greater than
2.5 were associated with high bleeding risk. Bleeding events requiring
transfusion were significantly more frequent in patients taking
lepirudin than in historical control patients (P = .02). In
conclusion, this meta-analysis provides further evidence that lepirudin
is an effective and acceptably safe treatment for patients with HIT.
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