Abstract: |
BACKGROUND: Warfarin-associated major hemorrhage is frequently treated with prothrombin complex concentrates to correct international normalized ratio (INR). OBJECTIVE: This article aims to investigate the efficacy of activated prothrombin complex concentrate (aPCC) versus 4-factor prothrombin complex concentrate (4PCC) for vitamin K antagonist reversal in patients with warfarin-associated major hemorrhage. MATERIALS AND METHODS: This was a multicenter, retrospective cohort study. Patients included were age?=?18 years with pretreatment INR of?>?1.5. Exclusion criteria were patients treated for urgent procedures without hemorrhage, treated but not taking warfarin, unavailable INR values, and pregnant patients. Patients were stratified into two groups: aPCC or 4PCC. The primary outcome was achievement of INR?=?1.5 at the posttreatment INR sampling. Secondary outcomes focused on thrombotic events and mortality. RESULTS: Of 342 patients, 237 patients received aPCC and 105 patients received 4PCC. After 1:1 propensity score matching, 86 patients remained in each group. In the matched cohort, the proportion of patients who achieved target INR?=?1.5 was greater with 4PCC (aPCC?=?61 [70.9%] vs. 4PCC?=?76 [88.4%]; 95% confidence interval [CI] -29.2% to -5.7%) and groups had comparable in-hospital thrombotic events and mortality. In the unmatched cohort, achievement of target INR?=?1.5 was greater with 4PCC (aPCC?=?151 [63.7%] vs. 4PCC?=?92 [87.6%]; 95% CI -32.7% to -15.1%). CONCLUSION: In the treatment of warfarin-associated major hemorrhage, 4PCC compared with aPCC was associated with greater achievement of INR?=?1.5 with comparable thrombotic events and mortality. Further controlled studies are needed to confirm these findings and determine the optimal dosing strategy that maximizes efficacy and safety. |