Key result
Withholding preoperative 4F-PCC fails to confirm noninferiority for surgical bleeding in apixaban-treated kidney transplant recipients.
Why the study?
Does preoperative 4F-PCC reduce surgical-bed bleeding in adult kidney transplant recipients taking apixaban?
Cohort (n=50)
Yes
Does preoperative 4F-PCC reduce surgical-bed bleeding in adult kidney transplant recipients taking apixaban?
Effect estimate: difference 1.6% (95% CI upper one-sided 21.5%)
Absolute Event Rate: 5.6% vs 7.1%
p-value: p=0.11
Withholding preoperative 4F-PCC in apixaban-treated kidney transplant recipients appears safe, with surgical-bed bleeding rates comparable to those receiving routine reversal.
Not noninferior for bleeding when withholding 4F-PCC; leaves open reversal strategy in apixaban kidney transplant recipients.
The use of apixaban prior to kidney transplantation is on the rise. However, optimal perioperative management remains uncertain, particularly regarding the need for preoperative reversal with four-factor prothrombin complex concentrate (4F-PCC). Prior reports suggest clinically relevant bleeding without reversal, but potential thrombotic consequences of prophylactic 4F-PCC warrant caution. We hypothesized that withholding preoperative 4F-PCC in patients taking apixaban before kidney transplantation would not increase early postoperative surgical-bed bleeding. METHODS: This retrospective, two-center study included adult kidney transplant recipients (KTRs) from January 2019 to September 2025 who had taken apixaban within 48 h before surgery. Patients were stratified by receipt versus nonreceipt of preoperative 4F-PCC. The primary endpoint was surgical-bed bleeding within 3 days of transplant. A one-sided noninferiority test (margin of 15%) was used for the primary endpoint. RESULTS: Fifty KTRs were included, and 14 (28%) received preoperative 4f-PCC and 36 (72%) did not. The median time since the last known apixaban dose was 21 h (interquartile range [IQR], 16-24 h) before transplant. Surgical-bed bleeding occurred in 7.1% in the preoperative 4F-PCC cohort and in 5.6% of the no preoperative 4F-PCC cohort (differences, 1.6%; upper one-sided confidence interval [CI], 21.5%; p = 0.11), suggesting similar event rates but not confirming noninferiority. No significant differences were observed between groups in transfusion requirements, delayed graft function, kidney function, venous thromboembolism (1 in the reversal group; 0 in the non-reversal group), or reoperation. Two deaths occurred in the reversal group. CONCLUSIONS: Withholding preoperative 4F-PCC in apixaban-treated KTR appears safe, with surgical-bed bleeding rates comparable to those in patients who received preoperative 4F-PCC. Findings support individualized rather than routine preoperative reversal strategies to balance bleeding and thrombotic risks.
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Cotiguala et al. (2026) conducted a cohort in Kidney transplantation in patients taking apixaban (n=50). Withholding preoperative 4F-PCC vs. Preoperative 4F-PCC was evaluated on Surgical-bed bleeding within 3 days of transplant (difference 1.6%, 95% CI upper one-sided 21.5%, p=0.11). Withholding preoperative 4F-PCC in apixaban-treated kidney transplant recipients yielded 5.6% surgical-bed bleeding vs 7.1% with 4F-PCC (p=0.11), failing to confirm noninferiority.
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