TITLE: Prothrombin complex concentrate versus fresh frozen plasma in patients on oral anticoagulant therapy undergoing cardiac surgery: a randomized study

  ABSTRACT:


BODY.INTRODUCTION:
To reverse oral anticoagulant (OAC) therapy, a number of treatment modalities is available. Fresh frozen plasma (FFP) is effective and is currently used for coagulation factor replacement, carrying a risk of volume overload, transmission of infective agents and being time consuming. Variable and frequently low potency of clotting factors results in minor haemostatic effects compared with prothrombin complex concentrates (PCC), which are considered very effective and safe. PCC PPSB-SD® has constant, highly concentrated levels of factors II, VII, IX and X compared with FFP. We studied the efficacy of the intraoperative administration of PCC and FFP in patients on OAC therapy undergoing heart surgery with cardiopulmonary bypass (CPB).

BODY.METHOD:
After Ethical Committee approval and informed consent, 40 patients (P group, n = 20; FFP group, n = 20) with a preoperative INR ≥ 2.1 were studied. PCC was supplied as 500 IU factor IX (20 ml) vials. The dose was calculated on the basis of body weight, the initial INR and the target INR aiming at an INR of 1.5 after protamine. One-half of this dose was administered before the start of CPB. After weaning from CPB and protamine, the second half-dose was given in order to reach a postoperative INR ≤ 1.5. In case the INR value was still too high a further dose of PPSB was given. In the FFP group, each patient received 4 units: one-half of this dose was given before CPB and the other half after CPB. Additional FFP was given until the INR had reached a satisfactory level. In cases of poor response and/or if there was a danger of volume overload, PCC was given. A portable coagulation monitor (CoaguChek) was used for INR measurements. Blood sampling was preoperative (T-1), preincision (T0), preadministration and postadministration before CPB (T1, T2), during CPB at 15 and 45 min (T3, T4), at the end of CPB (T5), after protamine administration (T6), and 15 and 60 min and 3 and 16 hours post-CB (T7–T10).  Analyses performed were: INR, PT, Hct, ACT, aPTT, ad factors II, VII, IX, X and FV. The amount of blood lost in the chest tube drainage and the blood products administered was also registered. Statistical evaluations were performed using the Student t test, repeated-measurements ANOVA and Fisher's exact test.

BODY.RESULTS:
The P group was more successful in reaching the target INR. In the FFP group 16/20 (80%) patients received an additional dose of PPSB vs 6/20 (30%) in the PCC group. The INR with PCC treatment dropped sooner below 1.5 than that in the FFP group. More patients in this group reached the target INR in the first hour after ending CPB (T7, P < 0.007). We found a significant difference between groups in factor II (P = 0.023) and factor X (P = 0.008) levels over time.

BODY.CONCLUSION:
The results of our study support the use of PCC in patients on OAC therapy facing semi-urgent or urgent cardiac surgery. Treatment with PCC reverses anticoagulation safely, more rapidly and more effectively than FFP.

Question: Compared to fresh frozen plasma what was the result of prothrombin complex concentrates (PCC) on factor II and factor X?
Evidence: More patients in this group reached the target INR in the first hour after ending CPB (T7, P < 0.007).
Answer: significantly increased