How to manage the transition of dabigatran (Pradaxa) therapy?

From the Guidelines

To manage the transition of dabigatran therapy, the last dose of dabigatran should be given 3 days before surgery in patients with normal or mildly impaired renal function, and 5 days before surgery in patients with moderately impaired renal function, with resumption of dabigatran 24 hours after low bleeding risk surgery and 2-3 days after high bleeding risk surgery, at a dose of 150 mg twice daily. When considering the transition of dabigatran therapy, it is crucial to take into account the patient's renal function, as it significantly affects the drug's half-life and anticoagulant effect 1. The suggested preoperative management approach is outlined in Table 4, which provides guidance on when to stop dabigatran before surgery based on renal function and bleeding risk.

For patients undergoing low bleeding risk surgery, dabigatran can be resumed on the day after surgery, 24 hours postoperative, at a dose of 150 mg twice daily, as suggested in Table 5 1. In contrast, for patients undergoing high bleeding risk surgery, dabigatran should be resumed 2-3 days after surgery, 48-72 hours postoperative, at a dose of 150 mg twice daily. It is also important to consider the patient's risk for thromboembolism, as this may influence the decision to administer a reduced dose of dabigatran in the postoperative period.

Key considerations in managing the transition of dabigatran therapy include:

• Patient renal function: normal or mildly impaired (CrCl ≥50 mL/min) versus moderately impaired (CrCl 30-50 mL/min)
• Type of surgery: low bleeding risk versus high bleeding risk
• Timing of dabigatran resumption: 24 hours after low bleeding risk surgery and 2-3 days after high bleeding risk surgery
• Dabigatran dose: 150 mg twice daily, with consideration for reduced dose in patients at high risk for thromboembolism.

By following these guidelines, clinicians can effectively manage the transition of dabigatran therapy, minimizing the risk of bleeding and thrombotic complications, and optimizing patient outcomes 1.

From the FDA Drug Label

To reduce this risk, consider coverage with another anticoagulant if dabigatran etexilate capsules are discontinued for a reason other than pathological bleeding or completion of a course of therapy (2.6,2.7,2.8,5. 1). Review recommendations for converting to or from other oral or parenteral anticoagulants (2.6,2. 7) Temporarily discontinue dabigatran etexilate capsules before invasive or surgical procedures when possible, then restart promptly (2.8)

To manage the transition of dabigatran (Pradaxa) therapy, consider the following key points:

• If dabigatran is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant to reduce the risk of thrombotic events 2.
• Review recommendations for converting to or from other oral or parenteral anticoagulants when transitioning therapy 2 2.
• Temporarily discontinue dabigatran before invasive or surgical procedures when possible, and restart promptly after the procedure 2 2. Main considerations for transitioning dabigatran therapy include:
• Thrombotic risk
• Alternative anticoagulant coverage
• Converting to or from other anticoagulants
• Surgical or invasive procedures

From the Research

Managing Dabigatran Therapy Transition

To manage the transition of dabigatran (Pradaxa) therapy, several factors need to be considered, including the patient's condition, renal function, and potential interactions with other medications.

• When transitioning to dabigatran, it is essential to monitor renal function, as renal impairment increases the risk of bleeding 3.
• Dabigatran does not require monitoring of haemostasis, but close monitoring of the patient is necessary, especially for changes in renal function 3.
• The effects of dabigatran are potentiated by combination with P-glycoprotein inhibitors and drugs that impair renal function, so combination with other antithrombotic agents should be avoided 3.
• In patients with atrial fibrillation and a high risk of thrombosis, dabigatran can be an alternative to warfarin, especially when the risk is significant and the INR cannot be maintained within the target range despite close monitoring 3, 4.

Transitioning from Warfarin to Dabigatran

When transitioning from warfarin to dabigatran, the following steps can be taken:

• Discontinue warfarin and start dabigatran when the international normalized ratio (INR) is below 2.0 5.
• Monitor the patient closely for signs of bleeding or thrombosis, and adjust the dabigatran dose as needed 5.
• Consider the use of low-molecular-weight heparin or unfractionated heparin during the transition period, especially in patients with a high risk of thrombosis 5.

Reversing Dabigatran Anticoagulation

In cases of bleeding, dabigatran anticoagulation can be reversed using idarucizumab, which has been approved for dabigatran reversal 6.

• Idarucizumab can be administered intravenously to rapidly reverse the effects of dabigatran 6.
• The use of prothrombin complex concentrate (PCC) or fresh frozen plasma may also be considered in cases of major bleeding, although the evidence for their use in dabigatran reversal is limited 6.