Comparative effectiveness of 3- versus 4-factor prothrombin complex concentrate for emergent warfarin reversal

• We examine PCC administration for emergent warfarin reversal
• Safety and effectiveness of 3- and 4-factor PCC are compared
• Survival higher with 4-factor PCC, and INR ≤ 1.5 thirty minutes after PCC
• Thromboembolic events were low in both groups

IntroductionThree- and 4-factor prothrombin complex concentrates (PCC) are routinely administered for emergent reversal of warfarin, but direct comparisons of clinical outcomes are lacking. The purpose of this study was to compare the safety and effectiveness of 3- and 4-PCC in patients requiring emergent warfarin reversal.Materials and MethodsThis was a single-center retrospective study in adult patients requiring administration of either 3-PCC or 4-PCC for emergent reversal of warfarin.ResultsOne hundred sixty-five patients were included (3-PCC, n = 109; 4-PCC, n = 56). The most frequent indications for PCC were intracranial and gastrointestinal bleeding. Baseline median INR was 2.5 (2.0-3.2) and 2.4 (2.0-4.2) in the 3-PCC and 4-PCC groups. Thirty minutes after PCC administration, median INR decreased to 1.3 in both groups (p < 0.001), and 87 (80%) versus 47 (84%) of patients had INR values ≤ 1.5 (p = 0.52) in the 3-PCC group versus the 4-PCC group. Thromboembolic events occurred in 7 patients (4%) and were similar between the 3-PCC (n = 3, 3%) and 4-PCC (n = 4, 7%) groups (p = 0.23). Thirty-four (31%) patients in the 3-PCC group died compared to 5 patients (9%) in the 4-PCC group (p = 0.001). INR > 1.5 thirty minutes after PCC was associated with increased mortality (OR 4.3; 95% CI 1.8-10.4, p = 0.001), and administration of a 4-PCC was associated with decreased mortality (OR 0.19; 95% CI 0.06-0.54, p = 0.002).ConclusionPatients who received 4-PCC, and those with INR ≤ 1.5 regardless of type of PCC received were more likely to survive. Thromboembolic events were low in both groups and similar to previous studies.