Prothrombin Complex Concentrate (Octaplex^®) In Patients Requiring Immediate Reversal of Vitamin K Antagonist Anticoagulation.

Rapid reversal of vitamin K antagonists (VKAs) is required when patients experience acute bleeding or are in need of urgent surgery. Traditionally, in Canada, the only therapeutic option for warfarin reversal was fresh frozen plasma (FFP); recently a four factor prothrombin complex concentrate (PCC) has become available. In this retrospective chart review, we examined the use of Octaplex^®, a four factor (FII, FVII, FIX, FX), solvent/detergent (S/D) treated and nanofiltered PCC, in a tertiary care centre over 18 months (November 2008 to May 2010), to determine its efficiency and safety in VKA reversal. The PCC was used 85 times in 82 patients. All patients had received warfarin prior to PCC administration. Patients received a mean dose of 1792 (1000 – 3500) IU of PCC for treatment of bleeding (36), urgent surgery (40) and excessively elevated international normalized ratio (INR) (8). One patient received PCC for an unknown indication and is excluded from the results presented here; a further 6 patients did not have INR tests done immediately before and immediately after PCC administration and are excluded from the laboratory results presented here. The mean INR before administration of the PCC was 5.10 (range 1.2 – 25). The mean INR after administration of the PCC was 1.43 (range 0.9 – 3.3). Forty-seven of seventy-nine [59.5%, 95% CI 47.9 to 70.4%] administrations resulted in an INR of 1.3 or less and 60/79 [75.9%, 65.0 to 84.9%] resulted in an INR of 1.5 or less. Of the 40 patient encounters where PCC was administered due to need for urgent surgery, 39 were able to undergo the procedure. Three patients experienced a thromboembolic event; one had a venous thromboembolism due to a clot extension of a previously diagnosed left leg DVT 8 days after PCC administration, another had a non-occlusive renal vein clot 8 days after PCC administration and the last had a cilioretinal artery occlusion 238 days after receiving PCC. No other adverse events potentially related to PCC were observed. We conclude that the prothrombin complex concentrate Octaplex^® provides efficacious, safe and rapid reversal of VKA therapy.

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Crowther:Pfizer: Consultancy, Research Funding; Sanofi Aventis: Consultancy, Research Funding; Leo Laboratories: Consultancy, Research Funding; Artisan: Consultancy. Off Label Use: The product described in this abstract is not available in the US. The described use is “on label” in Canada.