Abstract Number: PB1142
Meeting: ISTH 2020 Congress
Background: Patients with hemophilia A or B are at risk of excess blood loss when undergoing surgical procedures and require management of hemostasis during the perioperative period. Fitusiran is a once-monthly subcutaneously administered investigational RNA interference (RNAi) therapeutic that targets antithrombin (AT) to enhance thrombin generation and rebalance hemostasis for people with hemophilia A or hemophilia B, with or without inhibitors. Successful perioperative hemostatic management of patients treated with fitusiran prophylaxis has been observed in a variety of surgical procedures, including a thoracotomy/partial lung segmentectomy, molar tooth extraction, premolar tooth extraction, nasal septoplasty, and endoscopic cholecystectomy. Data from additional surgical procedures are needed to better define the hemostatic coverage provided by fitusiran and appropriate perioperative hemostatic management plans.
Aims: To describe the hemostatic management of patients with hemophilia A or B who underwent surgical procedures while receiving fitusiran prophylaxis.
Methods: Fitusiran was evaluated in a phase 1 dose-escalation study (NCT02035605) followed by a phase 2 open-label extension (OLE) study (NCT02554773) that included patients with hemophilia A or B, with or without inhibitors. Patients who were eligible to continue in the phase 2 OLE study received monthly fixed subcutaneous doses of fitusiran 50 mg or 80 mg. Data on perioperative hemostatic therapies and hemostatic response were collected for patients undergoing surgical procedures who had lowered AT during the study.
Results: In addition to 5 previously presented surgical procedures, 1 total knee replacement and 1 total hip replacement were performed. Further details on perioperative treatment regimens and hemostatic responses in all 7 procedures will be presented.
Conclusions: Successful perioperative hemostatic management of patients in the context of AT lowering with fitusiran has now been observed in several orthopedic, thoracic, gastrointestinal, maxillofacial, and dental surgical procedures.
To cite this abstract in AMA style:Pasi KJ, Négrier C, Ragni M, Georgiev P, Lissitchkov T, Kichou S, Mei B, Andersson S. Perioperative Management of Patients with Hemophilia Receiving Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/perioperative-management-of-patients-with-hemophilia-receiving-fitusiran-an-investigational-rnai-therapeutic-targeting-antithrombin-for-the-treatment-of-hemophilia/. Accessed March 4, 2024.
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