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Abstract
Data on the use of activated prothrombin complex concentrate (aPCC) for the management of warfarin associated major bleeding is sparse. The objective of the study was to assess the achievement of effective clinical hemostasis using aPCC in patients presenting with major bleeding while on warfarin. We also assessed the safety of the drug. This retrospective study was conducted at a tertiary care teaching center in the USA where patients with major bleeding while receiving warfarin, and received aPCC were included. Efficacy of aPCC in achieving effective hemostasis was assessed according to the International Society of Thrombosis and Hemostasis Scientific and Standardization Subcommittee criteria. Efficacy was also assessed by achieving INR < 1.5 after treatment. The primary safety endpoint was the occurrence of any thromboembolic complications. A total of 67 patients were included in the study. The most common site for bleeding was intracerebral hemorrhage (n = 37, 55.2%), followed by gastrointestinal bleed (n = 26, 38.8%). Clinical hemostasis was achieved in 46 (68.7%) patients and of the 21 (31.3%) patients who did not achieve clinical hemostasis, 16 died. Thirty nine (58.2%) patients achieved INR < 1.5. Five (7.5%) patients developed thromboembolic complications. This study suggests that the use of aPCCs is effective in achieving effective hemostasis in patients on warfarin presenting with major bleeding.
Highlights
Abbreviations atrial fibrillation (AF) Atrial fibrillation Activated PCC (aPCC) Activated prothrombin complex concentrate (PCC) deep venous thrombosis (DVT) Deep venous thrombosis fresh frozen plasma (FFP) Fresh frozen plasma GI Gastrointestinal ISTH International Society of Thrombosis and Hemostasis pulmonary embolism (PE) Pulmonary embolism PCC Prothrombin complex concentrate recombinant factor VIIa (rFVIIa) Recombinant factor VIIa vitamin K antagonist (VKA) Vitamin K antagonist
Activated PCC contains inactive factors II, IX, and X, but in contrast to 4-factor PCC (4PCC), contains activated factor VII, and FEIBA (Baxter, Westlake, CA) is the only commercially aPCC in the USA. aPCC is comparable to previously studied combination regimens consisting of 3-factor PCC (3PCC) and recombinant factor VIIa3
Thirty nine (58.2%) patients achieved an International Normalization Ratio (INR) < 1.5 post treatment with aPCC, and four patients died before a repeat INR was obtained
Summary
Abbreviations AF Atrial fibrillation aPCC Activated PCC DVT Deep venous thrombosis FFP Fresh frozen plasma GI Gastrointestinal ISTH International Society of Thrombosis and Hemostasis PE Pulmonary embolism PCC Prothrombin complex concentrate rFVIIa Recombinant factor VIIa VKA Vitamin K antagonist. Studies comparing 3PCC + rFVIIa with 4PCC found that 3PCC + rFVIIa achieved greater reductions in International Normalization Ratio (INR) compared to 4PCC, both regimens were able to achieve an INR < 1.5 These studies found that 3PCC + FVIIa had tenfold higher incidence of deep venous thrombosis (DVT) compared to 4PCC4. Extrapolations from these findings, along with previous hemophiliarelated data, have led to concerns that aPCC therapy carries inherently increased risks for coagulopathies. They found no difference in post-treatment thrombotic complications when comparing aPCC and 4 PCC5
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