Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data

Michael J. Paidas; Elizabeth W. Triche; Andra H. James; Maria DeSancho; Christopher Robinson; John Lazarchick; Sara Ornaghi; Johan Frieling

doi:10.1055/s-0035-1564423

American Journal of Perinatology, Inhaltsverzeichnis

Am J Perinatol 2016; 33(04): 343-349
DOI: 10.1055/s-0035-1564423

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Recombinant Human Antithrombin in Pregnant Patients with Hereditary Antithrombin Deficiency: Integrated Analysis of Clinical Data

Michael J. Paidas

¹Yale Women and Children's Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut

,

Elizabeth W. Triche

²Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island

,

Andra H. James

³Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina

,

Maria DeSancho

⁴Division of Hematology-Oncology, Weill Cornell Medical Center, New York, New York

,

Christopher Robinson

⁵Department of Obstetrics and Gynecology, University of South Carolina, Columbia, South Carolina

,

John Lazarchick

⁶Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina

,

Sara Ornaghi

¹Yale Women and Children's Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut

⁷Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Milan-Bicocca, Monza, Italy

,

Johan Frieling

⁸Department of Clinical Development, rEVO Biologics, Framingham, Massachusetts

› Institutsangaben

Abstract

Objectives The purpose of this analysis was to evaluate the use of recombinant human antithrombin (rhAT) in preventing venous thromboembolism (VTE) in pregnant patients with hereditary AT deficiency (HATD).

Study Design Data from two clinical trials were pooled. Dosing of rhAT was based on body weight and baseline AT activity, started up to 24 hours before scheduled induction or cesarean delivery, or at the onset of labor.

Results A total of 21 pregnant HATD patients were enrolled. Mean rhAT therapy duration was 4.3 days and dose was 245.1 IU/kg/day. All patients achieved target mean AT activity (80–120% of normal) during rhAT therapy. There were no confirmed VTEs during rhAT treatment or within 7 ( ± 1) days after dosing. Two VTE events (one deep vein thrombosis and one pulmonary embolism) occurred 11 and 14 days after discontinuation of rhAT, in patients managed with prophylactic doses of heparin or low-molecular-weight heparin following delivery.

Conclusion rhAT was safe and effective in pregnant HATD patients when administered during the peripartum period, the period of highest VTE risk and a time when anticoagulation therapy is normally withheld. Pregnant HATD patients may benefit from therapeutic, rather than prophylactic, doses of anticoagulation after delivery to protect against postpartum VTE.

Keywords

recombinant human antithrombin - antithrombin deficiency - pregnancy - venous thromboembolism

Volltext

Referenzen

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