The quality of evidence is downgraded by study limitations (lack of allocation concealment and blinding), by inconsistency (variability in results), and by imprecise results (few patients and outcome events and wide confidence intervals).
A Cochrane review [Abstract] 1 included 4 studies with a total of 453 subjects. The review assessed the benefits and harms of prothrombin complex concentrate (PCC) compared with fresh frozen plasma (FFP) in the acute medical and surgical setting involving vitamin K antagonist-treated bleeding (3 studies) and non-bleeding (1 study) patients undergoing reversal therapy. All studies assessed the use of weight-based and INR-based PCC administration with infusion of FFP. Formulation and dose of PCC, and time of PCC administration differed between studies. All studies but one co-administered vitamin K to both intervention and control groups.
No statistically significant effect on mortality or number of serious adverse events (e.g. life-threatening thrombotic events such as acute myocardial infarction, pulmonary embolism or cerebral venous thromboembolism) was observed. No statistically significant difference was observed in the number of new occurrences of red blood cell (RBC) transfusion (table T1).
| Outcome | Relative effect (95% CI) | Assumed risk - control (FFP) | Corresponding risk - PCC (95% CI) | Participants (studies) |
|---|---|---|---|---|
| Overall mortality | RR 0.93 (0.37 to 2.33) | 84 per 1000 | 78 per 1000 (31 to 195) | 421 (3 studies) |
| Number of new occurrences of RBC transfusion | RR 1.08 (0.82 to 1.43) | 319 per 1000 | 344 per 1000 (262 to 456) | 376(2 studies) |
| Number of complications probably related to the intervention | RR 0.92 (0.78 to 1.09) | 573 per 1000 | 527 per 1000 (447 to 625) | 442(4 studies) |
However, use of PCC seemed to enable reversal of vitamin K-induced coagulopathy without the need for transfusion of FFP. One study showed that the comparator FFP arm required considerably more therapeutic measures to reach the target INR value (20/20 participants) compared with 6/20 participants in the PCC arm. Specifically, the FFP arm required a total of 19.4 L FFP additional to the 8 L intended in the protocol (400 mL × 20 participants). Furthemore, intermittent use of PCC was needed to achieve the target INR value in the FFP arm. Another study showed that introducing the use of PCC reduced the mean volume of FFP transfused from 2712 mL (SD = 346 mL) to 399 mL (SD = 271 mL), and a third study showed that total avoidance of FFP was possible for urgent reversal of VKA therapy in major bleeding events.
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