|The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
The use of prothrombin complex concentrates (PCCs) was associated with decreased red blood cell (RBC) and platelet transfusions compared with use of frozen plasma (FP) in patients who experienced bleeding after cardiopulmonary bypass (CPB) surgery, according to results of a substudy of FIBRES (ClinicalTrials.gov Identifier: NCT03037424), presented as the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
The findings were presented by Justyna Bartoszko, MD, MSc, FRCPC, of Toronto General Hospital at the University of Toronto in Canada.
“Significant bleeding and cardiac surgery is unfortunately a common event [in] cardiac surgical procedures, accounting for 20% [of] transfusions in North America, and 20[%] to 40% of patients undergoing routine cardiac surgery like coronary artery bypass surgery will have a transfusion,” said Dr Bartoszko.
Because PCCs may be more effective and easier to administer than FP, the investigators aimed to describe the association of comparable PCC or FP doses with transfusion requirements and adverse outcomes after CPB surgery.
The primary outcome for this post-hoc analysis of the FIBRES data was RBC transfusion within 24 hours of CPB, and secondary outcomes included platelet transfusion within 24 hours of CPB and adverse postoperative outcomes. Patients who received only PCC or FP were included in the analysis.
Between 2017 and 2018, 735 patients participated in FIBRES at 11 Canadian institutions. Of those, 416 patients (56%) experienced significant post-CPB bleeding (women, 31%; complex surgery, 77%; urgent surgery, 39%; and critical preoperative status, 22%). Most patients with post-CPB bleeding received FP (n=344, 83%), while PCC was used in 17% of the patients (n=72; 2 patients did not have PCC dosing recorded and were subsequently excluded from the analysis).
Overall, 87% of the patients in the FP group required RBC transfusion per 1 unit (unadjusted odds ratio [OR], 1.47; 95% CI, 1.27-1.71; P <.01) compared with 66% in the PCC group per 500 units (unadjusted OR, 0.72; 95% CI, 0.62-0.83; P <.01). The median number of RBC units transfused overall was 3 (IQR, 1-5), and the median number of platelet pools was 2 (IQR, 1-3).
After adjusting for a number of patient and baseline factors, the results were consistent with those of the unadjusted analysis. Each unit of FP was associated with an increased risk of RBC transfusion (aOR, 1.50; 95% CI, 1.29-1.75); P <.01), while each 500 units of PCC was associated with decreased risk (aOR, 0.70; 95% CI, 0.60-0.83; P <.01). Similar results were observed for associations with platelet transfusion (per unit of FP aOR, 1.41; 95% CI, 1.14-1.73; P <.01 and per 500 units of PCC aOR, 0.81; 95% CI, 0.71-0.93; P <.01).
Of all patients, 16% experienced thromboembolic events within 28 days, 13% had fluid overload or respiratory events within 28 days, 35% had renal events within 7 days, and 19% required surgical re-exploration for bleeding post-CPB. No adverse events were increased with PCC use compared with FP use.
Limitations included potential confounding factors and provider choice of FP or PCC use.
“[O]ur substudy affirms the results of previous retrospective analyses and a recent meta-analysis also suggesting that PCC use is effective and likely safe in the context of cardiac surgery.”
Disclosures: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
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Bartoszko J, Karkouti K, Callum J. The association of prothrombin complex concentrates with transfusion requirement and postoperative outcomes in cardiac surgery: a post-Hoc analysis of the FIBRES randomized controlled trial. Presented at: 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 99.