Melissa Santibañez, Assistant Professor in the College of Pharmacy (pictured below), recently presented clinical research at the Society of Critical Care Medicine’s 47th Annual Congress (Feb 2018, San Antonio, TX). The project, entitled “Safety & efficacy of 4F-PCC for warfarin and non-warfarin major bleeding & emergent surgery,” was initiated and completed during Dr. Santibañez’s PGY2 residency at NewYork-Presbyterian Hospital (New York, NY). Dr. Santibañez provided a 4-minute presentation on her research to an audience of critical care physicians, pharmacists, and advanced practice nurses as part of the conference’s Research Snapshot Theater presentations highlighting original clinical research.
This research was a retrospective, descriptive assessment of 216 patients who received the targeted 4F-PCC reversal agent, Kcentra, and stratified patients by their indication for reversal (major bleeding, emergent surgery, or coagulopathy). The primary outcome was thromboembolic events within 14 days of 4F-PCC, and the secondary outcome was hemostatic effectiveness within 24 hr of 4F-PCC. 4F-PCC is currently the standard of care for reversal of warfarin-induced major bleeds and is also frequently used for warfarin reversal prior to emergent surgery. 4F-PCCs are also recommended for reversal of direct-acting oral anticoagulants (DOACs) based on retrospective trial data, although high-powered, randomized controlled trials on its full safety and efficacy profile are currently lacking.
This research found higher thromboembolic event rates and lower hemostasis rates overall than what was observed in the prospective pivotal clinical trials for warfarin reversal. This research contributes new data on the tolerability and effectiveness of 4F-PCC in patient subgroups on whom very limited risk/benefit data is available in the published literature, including DOACs, coagulopathies, massive transfusion protocol activations, and LVAD explant to heart transplants.
For more information on this project or this presentation, please contact Dr. Santibañez directly (msantibanez@myularkin.org).
