FEIBA™ for Patients on Direct Oral Anticoagulants Requiring Urgent Surgery
Bibliographic record
Abstract
Abstract Introduction: A recent Canadian population based review showed a rapid increase in use of direct oral anticoagulants (DOACs) for prevention of systemic embolism in patients with atrial fibrillation (AF) (Xu et al.). These drugs offer advantages over traditional vitamin K antagonists (VKA) including fixed dosing regimens and elimination of laboratory monitoring. In Canada, patients receiving VKA requiring urgent surgery are reversed with prothrombin complex concentrates (PCC) with or without vitamin K. DOAC specific antidotes are under development and use of PCCs or activated PCC for the purposes of DOAC reversal for emergent procedures is controversial. We describe the use of activated PCC (FEIBA™) in patients receiving the DOACs (dabigatran, apixaban, or rivaroxaban) who required urgent surgical intervention. Methods: A retrospective review of patients receiving DOACs and requiring urgent reversal of anticoagulation effect for procedures or surgery at The Ottawa Hospital between January 2013 and June 2014 are included. Major bleeding was defined using the ISTH criteria (Schulman et al.). The primary outcome was major bleeding peri-operatively and secondary outcome was adverse embolic and thrombotic events during follow up. Results: Five patients were identified: two patients were on rivaroxaban, two were on apixaban, and one was on dabigatran. Baseline characteristics are shown in Table 1. One patient was on rivaroxaban for secondary prevention of venous thromboembolism (VTE), while the remaining patients had AF. Three patients required laparotomy for bowel obstruction; one patient required open femur fracture repair; and one patient required angiography and stent placement for ischemic bowel. A large majority of patients (80%) had received a dose of anticoagulant on the day of surgery. One patient required intra-operative blood transfusion. There were no embolic or thrombotic complications following FEIBA™ administration and all patients’ survived hospitalization. Conclusions: The use of FEIBA™ for reversal of DOAC effect for urgent surgery in this cohort of patients was effective and not associated with adverse thrombotic complications. Prospective studies evaluating use of potential benefits and harms of FEIBA™ for reversal of DOACs in patients requiring emergent surgery are needed. Abstract 4259. Table 1: Patients on DOACs Requiring Urgent Procedure Patient (Age and Gender) Indication For DOAC [AF(CHADS2); VTE] DOAC and Dosage Surgery/ Procedure Units of PRBCs Transfused FEIBA™ Dose (IU) Adverse Events post-FEIBA™ administration Survived Hospitalization 91 Female AF (4) Rivaroxaban 15 mg daily Femur fracture ORIF 3, intra-operatively 1812 -- Yes 50 Male VTE Apixaban 5 mg BID Laparotomy for SBO 0 1350 -- Yes 50 Female AF (4) Apixaban 2.5 mg BID Angiography + SMA stent for ischemic bowel 0 3918 -- Yes 77 Male AF (2) Rivaroxaban 20 md daily Laparotomy for incarcerated hernia/SBO 0 3241 Venous oozing intra-operatively Yes 78 Male AF (3) Dabigatran 110 mg BID SBO/ Femoral hernia repair 0 6000 -- Yes AF = atrial fibrillation; BID = twice daily; CHADS = congestive heart failure, hypertension, age, diabetes, stroke; DOAC = direct oral anticoagulant; IU = international units; ORIF = open reduction internal fixation; PRBC = packed red blood cells; SBO = small bowel obstruction; SMA = superior mesenteric artery; VTE = venous thromboembolism References: Schulman, S et al. J Thromb Haemost 2010; 8: 202–4. Xu, Y et al. CMAJ Open 2013; 1:E115-E119. Disclosures Off Label Use: FEIBA is an activated prothrombin complex concentrate that was used during management of patients on direct oral anticoagulants requiring urgent surgery..
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".