Abstract
Background: The use of prothrombin complex concentrates (PCCs), namely three-factor PCC (3F-PCC) or four-factor PCC (4F-PCC) for urgent anticoagulation reversal is critical for damage control resuscitation. However, few reports if any in the trauma literature directly compares 3F-PCC vs. 4F-PCC use in trauma patients. We hypothesize that 3F-PCC and 4F-PCC differ in their efficacy, adverse effects and cost-effectiveness when used in trauma patients. Methods: All consecutive trauma patients with coagulopathy (INR ≥ 1.5) secondary to warfarin and rivaroxaban who received either 3F-PCC or 4F-PCC from 2010-2014 at our trauma center were reviewed. Multivariate analysis was conducted to control for confounding variables using IBM/SPSS version 19; p<.05 was considered statistically significant. Results: 46 patients received 3F-PCC and 18 received 4F-PCC. Indications for warfarin (95%) or rivaroxaban (5%) were: atrial fibrillation (67%), venous thromboembolism (28%) cerebrovascular vascular accident (13%), mechanical valve (8.7%), and other (4.4%). The initial PCC dose (IU/kg) was 30 for 3F-PCC and 26 for 4F- PCC. INR decreased after PCC from 3.4 to 1.6 for 3F-PCC and from 3.1 to 1.3 for 4F-PCC (p=.001). Successful reversal rates in patients were: 3F-PCC (50%) and 4F-PCC (83%), p=.022. After controlling for relevant covariates 4F-PCC was retained as an independent predictor for successful anticoagulation reversal: OR=5, 95% CI (1.2 – 19.6), p=.021. There were no deaths. Thromboembolic events were observed in 15% of patients with 3F-PCC vs. 0% with 4F-PCC (p=.177). Cost-effectiveness favored 4F- PCC ($5382 vs. $3797). Conclusions: In this retrospective study, 4F-PCC was associated with increased successful anticoagulation reversals without concomitant increase in thromboembolic events compared with 3F-PCC (83% vs. 50%). This improved rate led to a more favorable cost effectiveness profile for 4F-PCC. Replacing 3F-PCC with 4F-PCC for urgent coagulopathy reversal may benefit patients. Future prospective and long term follow-up studies are needed to validate these observations. Level of evidence: Level III retrospective comparative study without negative criteria. Study type: Therapeutic
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