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.
Research article published in Blood (2000)
Abstract
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 microg/L) decreased after the initiation of lepirudin (at 24 hours +/- 6 hours; median, 9.18 microg/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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
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.
Warum dies für die Hirudotherapie relevant ist
Diese Metaanalyse fasste Daten aus zwei prospektiven Studien zu Lepirudin (rekombinantes Hirudin) bei 113 Patienten mit HIT und thromboembolischen Komplikationen im Vergleich zu 91 historischen Kontrollen zusammen. Der kombinierte Endpunkt aus Tod, neuen thromboembolischen Komplikationen oder Gliedmaßenamputation trat bei 22,1 % der Lepirudin-Patienten auf, wobei die Ereignisraten von 6,1 % pro Patiententag vor der Behandlung auf 1,3 % während der Behandlung sanken; die optimale Wirksamkeit wurde bei aPTT-Verhältnissen von 1,5–2,5 erreicht, obwohl transfusionspflichtige Blutungen signifikant häufiger auftraten als in den Kontrollgruppen. Diese Metaanalyse stärkt die Evidenzgrundlage für den therapeutischen Nutzen eines aus Blutegeln gewonnenen Antikoagulans und ist unmittelbar relevant für das Fachgebiet der ASH. Allerdings stützt sich die Analyse auf historische Kontrollen und betrifft pharmazeutisches rekombinantes Hirudin und nicht eine Therapie mit lebenden Blutegeln.
Zitation
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