Table 1. Antithrombotic reversal and removal strategies in the management of perioperative bleeding risk in patients on antithrombotics—pros & cons.
| A specific solution | Pros | Cons |
|---|---|---|
| Idarucizumab | Approved for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding | Target: dabigatran only |
| Fast and effective reversal | Costly ($3,482) | |
| Potential rebound effect | ||
| Humanized monoclonal antibody fragment indicated in adult patients treated with dabigatran when reversal of the anticoagulant effect is needed for emergency surgery/urgent procedures, or in the event of life-threatening or uncontrolled bleeding; no contraindications; precautions to be taken in patients with hypersensitivity, hereditary fructose intolerance, and increased thromboembolic risk (45) | ||
| Andexanet alfa | Approved for life-threatening or uncontrolled bleeding | Not approved for emergency surgery/urgent procedures |
| Fast and effective reversal | Incompatible with heparin (e.g., during CPB) | |
| Target: rivaroxaban or apixaban (off-label use possible for edoxaban) | Potentially high risk of thrombotic events (10%) | |
| Costly ($24,750) | ||
| Potential rebound effect | ||
| A recombinant form of human factor Xa protein indicated in adult patients treated with apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding; contraindicated in known hypersensitivity; precautions to be taken prior urgent surgery, with heparin, higher risk of thrombosis for patients receiving the higher dose (46) | ||
| Bentracimab* | Rapid and sustainable reversal (preliminary data!) | Target: ticagrelor only |
| Potentially costly (estimation based upon prices of other monoclonal antibody technologies present in the market) | ||
| A neutralizing monoclonal antibody fragment that binds ticagrelor | ||
| Hemoadsorber | Fast and effective removal | Approved for intraoperative use on CPB only (Europe) |
| Target: ticagrelor and rivaroxaban (off-label use possible for apixaban, edoxaban, dabigatran) | ||
| Durable effect | ||
| Proven safety (no adverse events reported) | ||
| Cost-effective | ||
| Potential to expand outside of CPB-assisted cardiac surgery to different clinical settings with various platforms (CRRT, ECMO, etc., currently off-label) | ||
| A polymer based adsorption system designed in the area of extracorporeal therapies, indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin exist and for use intraoperatively during CPB surgery for the removal of ticagrelor and/or rivaroxaban; contraindicated in HIT positive patients when citrate regional anticoagulation is unavailable and in patients with very low platelet counts (<20,000/μL); relative contraindications include pregnancy, acute sickle cell crisis, concurrent immunosuppressive therapy, with the exception of corticosteroids, profound immunosuppression (e.g., CD4 <200 or neutropenia with ANC <1,000/μL); general precautions to be taken when handling extracorporeal blood purification techniques and discretion should be used when treating a patient weighing less than 45 kg (48) | ||
*, not approved, phase 3 clinical trial in progress NCT04286438. CPB, cardiopulmonary bypass; CRRT, continuous renal replacement therapy; ECMO, extracorporeal membrane oxygenation; HIT, heparin-induced thrombocytopenia; ANC, absolute neutrophil count.