How to manage anticoagulation in a patient on Xarelto (Rivaroxboxing) undergoing an orthopedic operation?

From the Guidelines

For a patient on Xarelto (rivaroxaban) undergoing an orthopedic operation, the anticoagulant should be stopped 2 days before surgery, as this corresponds to approximately 4 half-lives expired and a minimal residual anticoagulant effect at surgery, as suggested by the study published in Blood 1. When managing anticoagulation in such patients, several factors must be considered, including the type of surgery, the patient's renal function, and their thrombotic risk.

• The patient's renal function is crucial because rivaroxaban is partially eliminated through the kidneys, with about 33% of the drug depending on renal clearance 1.
• For patients with normal renal function, stopping rivaroxaban 2 days before surgery is recommended, but for those with impaired renal function, a longer duration of interruption may be required, although there are no published studies to guide this decision 1.
• Postoperative management involves resuming rivaroxaban, but not immediately; a low-dose regimen is suggested for the first 2 to 3 days after major surgery, followed by a treatment-dose regimen thereafter, as outlined in the study 1.
• For orthopedic operations, which can be considered major surgery, resuming rivaroxaban at a lower dose (10 mg once daily) for 2 days starting on the morning after surgery, and then increasing to the treatment dose (20 mg once daily) thereafter, can be a reasonable approach, based on the principles discussed in the study 1.
• It is also important to consider the patient's thrombotic risk; for those at high risk, bridging therapy with low-molecular-weight heparin (LMWH) may be necessary during the perioperative period, although this is not explicitly discussed in the context of rivaroxaban in the provided study 1.

From the FDA Drug Label

If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, XARELTO should be stopped at least 24 hours before the procedure to reduce the risk of bleeding [see Warnings and Precautions (5. 2)] . XARELTO should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established, noting that the time to onset of therapeutic effect is short [see Warnings and Precautions (5.1)] .

To manage anticoagulation in a patient on Xarelto (Rivaroxaban) undergoing an orthopedic operation, stop XARELTO at least 24 hours before the procedure to reduce the risk of bleeding.

• The decision to delay the procedure should weigh the increased risk of bleeding against the urgency of intervention.
• XARELTO should be restarted after the surgical procedure as soon as adequate hemostasis has been established.
• If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant 2.

From the Research

Managing Anticoagulation in Patients on Xarelto Undergoing Orthopedic Operations

To manage anticoagulation in a patient on Xarelto (Rivaroxaban) undergoing an orthopedic operation, several factors need to be considered, including the timing of the operation, the patient's risk of bleeding, and the need for anticoagulation therapy.

• The study 3 suggests that for urgent surgery with hemorrhagic risk, the drug plasma concentration should be less than or equal to 30ng/mL for rivaroxaban to enable surgery associated with a high bleeding risk.
• If the anticoagulant dosage is not immediately available, worse propositions, based on the usual tests (prothrombin time and activated partial thromboplastin time), are presented, although these tests do not really assess drug concentration or the risk of bleeding that depends on it.
• In case of serious bleeding in a critical organ, the effect of anticoagulant therapy should be reduced using a non-specific procoagulant drug as a first-line approach: activated prothrombin complex concentrate (aPCC) (FEIBA 30-50U/kg) or non-activated PCC (50U/kg) 3.

Perioperative Anticoagulation Regimens

Perioperative anticoagulation regimens for patients on Xarelto undergoing orthopedic operations can be informed by studies on low-molecular-weight heparin and rivaroxaban.

• A study 4 investigated the efficacy and safety of a standardized periprocedural anticoagulation regimen with low-molecular-weight heparin in patients at increased risk for arterial thromboembolism who require temporary interruption of warfarin therapy.
• Another study 5 found that rivaroxaban was associated with a lower 30-day risk of hospitalization with venous thromboembolism compared to low-molecular-weight heparin after total hip or knee arthroplasty.
• A review 6 of the pharmacology, pharmacokinetics, and clinical efficacy/safety profile of rivaroxaban for the prevention of venous thromboembolism in patients undergoing major orthopedic surgery found that rivaroxaban was significantly more effective for thromboprophylaxis in patients undergoing total knee replacement or total hip replacement, compared to enoxaparin.

Thrombotic and Bleeding Complications

Thrombotic and bleeding complications are major concerns during orthopedic surgery.

• A retrospective cohort analysis 7 found that increasing age, coronary artery disease, cancer, and chronic kidney disease were independent predictors of myocardial necrosis, whereas procedure type, cancer, female sex, coronary artery disease, and chronic obstructive pulmonary disease were independent predictors of major bleeding.
• The study 3 highlights the importance of managing anticoagulation therapy to minimize the risk of bleeding complications, particularly in patients undergoing orthopedic surgery.