Periprocedural warfarin reversal with prothrombin complex concentrate

Introduction: Approximately 10% of chronically anticoagulated patients require an invasive procedure annually. One in 10 procedures is emergent and requires prompt anticoagulation reversal. The study objective is to determine the safety and efficacy of a 3 factor prothrombin complex concentrate (PCC) for periprocedural anticoagulation reversal.

Materials and methods: Consecutive patients receiving 3 factor PCC for warfarin reversal for either urgent/emergent invasive procedures or major bleeding were analyzed. Primary endpoints included percent achieving INR <1.5, peri-operative major hemorrhage, thromboembolism and death during the 40day post-infusion period.

Results: Between January 1, 2010-December 31, 2012, 52 patients were treated with PCC for pre-procedural warfarin reversal and 113 patients for major bleeding. Within the peri-procedure group, there were 24 intra-abdominal surgeries, 12 percutaneous interventions, 6 cardiothoracic surgeries, 5 orthopedic and 3 endoscopic procedures. INR values <1.5 were achieved in 51% at 2.5h post-infusion. Major bleeding (13%), thromboembolism (13%) and mortality rates (15%) were high. Within the major bleeding group, PCC therapy reversed INR values (<1.5) in 75% of patients within 4h. For this group, thromboembolism (21%) and mortality rates (16%) were likewise high. Post-PCC anticoagulation, reinitiated in 37%, had no impact on bleeding or thrombotic complications. Mortality rates were threefold higher for those patients not restarting warfarin therapy.

Conclusions: Although PCC therapy promptly and effectively reverses INR values for patients requiring urgent/emergent invasive procedure both thromboembolic and fatal complications are soberingly high and call for judicious use of these agents in these high risk populations.