Table 3.

Comparative studies of PCC versus plasma for urgent VKA reversal in perioperative settings – 2008–2017

Citation & location of study	Study design	Surgical indication	Patients (n)	PCC used- manufacturer	Comparator	Key efficacy results	Key safety results
Agarwal et al. Neurosurger 2017; doi: 10.1093/neurs/nyx327(USA)	Retrospective cohort analysis	Neurosurgery	PCC: 28 FFP: 35	Not specified	FFP	• INR decreased from 3.36 to 1.36 with PCC and 2.92 to 1.33 with FFP • No significant difference between post-treatment INR for the PCC and FFP groups	• 1 and 0 TEEs were reported in the PCC and FFP groups within 72 h after infusion • No significant difference in in hospital mortality rates were observed (PCC, 17.9%; FFP, 14.3%)
Demeyereet al. Vox Sang. 2010; 99: 251– 60 (Belgium)	Prospective, randomized, two-arm, open label	Cardiac surgery	PCC: 18 FFP: 20	Cofact (Sanquin)	FFP	• 15 min post-CPB, INR ≤1.5 was reached by 7 and 0 patients receiving PCC and FFP, respectively • Median INR decrease was greater with PCC (from 2.7 to 1.6) than with FFP (2.6 to 2.3) 15 min post-CPB • 6 and 20 patients required an additional dose to reach INR target in the PCC and FFP groups, respectively	• 7 and 9 AEs were reported in the PCC and FFP groups, respectively • 2 patients in the FFP group reported excessive oozing
Fariboz Farsad et al. Iranian J Pharm Res 2015; 14: 877– 85 (Iran)	Randomized Study comparing PCC with FFP	Cardiac procedure	PCC: 25 FFP: 25	Uman Complex (Kedrion)	FFP	• 30 min post infusion, mean INR decreased from 4.02 to 2.34 for the PCC group and from 4.88 to 3.1 for FFP • 76% and 20% of patients achieved INR <2.5 in the PCC and FFP groups, respectively • 20% and 68% of patients needed additional doses to achieve target INR in the PCC and FFP groups, respectively	• No cases of hemorrhage were reported
Goldstein et al. Lancet 2015; 385: 2077–87 (USA, Belarus, Bulgaria, Lebanon, Romania, Russia)	Phase 3b, prospective randomized, open-label, active- control, multicentre study	Urgent surgery	PCC: 89 FFP: 90	Beriplex/Kcent a (CSL Behring)	FFP	• Effective hemostasis was achieved in 90% and 75% of patients in the PCC and plasma groups, respectively • INR ≤1.3 at 30 min post administration was achieved in 55% and 10% of patients in the PCC and plasma groups, respectively • Median time from start of infusion to start of surgery was significantly shorter in the PCC group (p=0.0098)	• AEs were seen in 56% and 60% of patients in the PCC and plasma groups, respectively • TEEs occurred in 7% and 8%, fluid overload developed in 3% and 13%, and late bleeding occurred in 3% and 5% of patients in the PCC and plasma groups, respectively • By Day 45, 3 and 8 deaths were reported in the PCC and plasma groups, respectively. Only 1 death (plasma group) was deemed related to treatment
Ortmann et al. Anesth Analg. 2015; 121: 26– 33 (UK)	Exploratory cohort study	Cardiac surgery	PCC: 45 FFP: 55	Beriplex/Kcent a (CSL Behring) and Octaplex (Octapharma)	FFP	• Cumulative blood loss was lower in the PCC group 1 and 12 hours following surgery compared with FFP • Similar numbers of units of red blood cells were transfused in both groups	• No DVT, pulmonary embolisms or MIs were seen in either group • Rates of cerebral infarction, hemorrhage and 30-day mortality were similar between the two groups
Refaai et al. Emerg Med Int. 2017; 2017: 8024356	Post hoc analysis	GI bleeding	PCC: 22 FFP: 20	Beriplex/Kcent a (CSL Behring)	FFP	• INR ≤1.3 30 min after infusion was achieved in 65% of patients with PCC vs 0% in patients with FFP • Median time between start of treatment and first procedure was 17.5 h with PCC vs 23.9 h with FFP	• TEEs occurred in 1 and 2 patients in the PCC and FFP groups, respectively • 1 and 4 fluid overload events occurred in the PCC and FFP groups, respectively

AE, adverse event; CPB, cardiopulmonary bypass; DVT, deep vein thrombosis; FFP, fresh frozen plasma; INR, international normalized ratio; MI, myocardial infarction; PCC, prothrombin complex concentrate; TEE, thromboembolic event