An international, multicenter, prospective study of a prothrombin complex concentrate, Prothromplex Total®, in anticoagulant reversal. Issue 3 (March 2015)

• Record Type: Journal Article
• Authors: Altorjay, Áron; Szabó, Éva; Boda, Zoltán; Kramer, Ludwig; Ngo, Leock Y.; Engl, Werner; Firth, Clair L.; Ahlstrom, Erik R.; Gelmont, David M.; Pabinger, Ingrid
• Is Part Of: Thrombosis research. Volume 135:Issue 3(2015)
• Page Start: 485
• Page End: 491
• Publication Date: 2015-03
• Subjects: Prothrombin complex concentrate -- Prothromplex total -- Anticoagulant reversal -- Oral anticoagulant -- Vitamin K antagonists; Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2014.12.026
• Languages: English
• ISSNs: 0049-3848

Abstract

Abstract: Introduction: Prothrombin complex concentrates (PCCs) are a common treatment option for the reversal of oral anticoagulation with vitamin K antagonists (VKAs). This study assessed efficacy and safety of Prothromplex Total®. Materials and Methods: Patients (≥ 18 years) with acquired prothrombin complex coagulation factor deficiency (international normalized ratio [INR] ≥ 2 at screening) due to oral VKAs, requiring reversal of anticoagulation, were treated with 25, 35, or 50 IU/kg BW PCC. After infusion, efficacy was assessed for 72 ± 4 hours. Adverse events (AEs) were captured for 15 days. Results: Sixty-one subjects, 48 requiring interventional procedures and 13 with acute bleeds, received a single infusion of PCC. Of 59 subjects analyzed, all achieved normalization of INR (≤ 1.3) within 30 ± 5 minutes of infusion, demonstrating effective anticoagulant reversal. IVRs of factors II, VII, IX, and X ranged from 1.12-2.03 IU/dL:IU/kg. Median INRs remained between 1.00 and 1.18 for up to 6 hours. Overall efficacy of treatment was rated "excellent" for 60 subjects. Three AEs were deemed possibly related to treatment: 1 serious AE (SAE) of acute myocardial infarction (rated severe), 1 SAE of deep vein thrombosis (rated mild), and 1 AE of pyrexia (rated mild). Thrombotic adverse events (2/61, 3.3%) reported here are comparable to rates observed in other PCC studies. Conclusions: While there is a risk of thromboembolic events following treatment with PCC products, the number of events reported here was low and could have occurred without PCC treatment. The individualized, INR-based dosing of PCC used here for VKA anticoagulant reversal produces rapid normalization of INR to ≤ 1.3 within 30 minutes. Highlights: We assessed efficacy and safety of a PCC product for anticoagulant reversal 59 subjects in total: 48 had interventional procedures; 13 treated for acute bleeds All subjects reached an INR ≤ 1.3 within 30 minutes of PCC infusion Safety was comparable to other PCC products