When to hold Pradaxa (dabigatran) prior to surgery in patients with impaired renal function?

Timing of Dabigatran (Pradaxa) Discontinuation Before Surgery in Patients with Impaired Renal Function

For patients with impaired renal function, dabigatran (Pradaxa) should be discontinued 3 days before surgery for moderate renal impairment (CrCl 30-50 mL/min) with low bleeding risk procedures, and 4-5 days before surgery for high bleeding risk procedures. 1

Renal Function and Dabigatran Clearance

Dabigatran is primarily eliminated by the kidneys, with renal impairment significantly affecting its clearance:

• Dabigatran has an elimination half-life of 14-17 hours in patients with normal or mildly impaired renal function
• In moderate renal impairment (CrCl 30-50 mL/min), the half-life extends to 16-18 hours
• In severe renal impairment, the half-life can double to approximately 28 hours 2

This prolonged half-life necessitates earlier discontinuation before surgical procedures to ensure minimal anticoagulant effect at the time of surgery.

Discontinuation Timeline Based on Renal Function and Procedure Risk

The timing for discontinuation should follow this algorithm:

1. Assess renal function using creatinine clearance (CrCl)
2. Determine bleeding risk of the planned procedure
3. Follow the appropriate discontinuation schedule:

Renal Function	Low Bleeding Risk Surgery	High Bleeding Risk Surgery
Normal/Mild impairment (CrCl ≥50 mL/min)	Last dose: 2 days before (skip 2 doses)	Last dose: 3 days before (skip 4 doses)
Moderate impairment (CrCl 30-50 mL/min)	Last dose: 3 days before (skip 4 doses)	Last dose: 4-5 days before (skip 6-8 doses)
Severe impairment (CrCl <30 mL/min)	Consider longer periods	Consider longer periods

FDA Recommendations

The FDA label for dabigatran specifically states: "If possible, discontinue dabigatran etexilate capsules in adults 1 to 2 days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before invasive or surgical procedures because of the increased risk of bleeding." 3

For major surgery, spinal procedures, or when complete hemostasis is required, longer discontinuation periods should be considered.

Resumption of Dabigatran After Surgery

Resumption timing depends on the bleeding risk of the procedure:

• Low bleeding risk procedures: Resume dabigatran 24 hours after surgery
• High bleeding risk procedures: Resume 48-72 hours after surgery

For patients at high thrombotic risk after high-risk procedures, consider starting with a reduced dose:

• 75-150 mg once daily for the first 1-2 days after surgery
• Then resume full dose (150 mg twice daily) 1

Important Considerations and Caveats

1. No bridging therapy is typically needed when interrupting dabigatran, unlike warfarin
2. Emergency situations: If surgery cannot be delayed, there is an increased risk of bleeding. Consider using idarucizumab (Praxbind) to reverse dabigatran's anticoagulant effect 3, 4
3. Laboratory assessment: If needed, use aPTT, thrombin time (TT), or ecarin clotting time (ECT) to assess residual anticoagulant activity, not INR 5
4. Dialysis option: In emergency situations, hemodialysis can remove 62-68% of dabigatran 2

Special Considerations for Severe Renal Impairment

For patients with severe renal impairment (CrCl <30 mL/min):

• The FDA label does not provide specific dosing recommendations for these patients 3
• Consider consulting with a hematologist or cardiologist before proceeding with elective surgery
• Longer discontinuation periods may be necessary due to the significantly prolonged half-life

By following these guidelines, you can minimize both bleeding risk during surgery and thrombotic risk from extended anticoagulant interruption in patients with impaired renal function.