How long before surgery should dabigatran (Pradaxa) be discontinued in patients with normal or impaired renal function?

From the Guidelines

Dabigatran should be discontinued 2 days before low-to-moderate-bleed-risk surgery and 4 days before high-bleed-risk surgery in patients with normal renal function (CrCl ≥50 mL/min), and 3-4 days before low-to-moderate-bleed-risk surgery and at least 5 days before high-bleed-risk surgery in patients with impaired renal function (CrCl <50 mL/min). This recommendation is based on the most recent and highest quality study available, which suggests that the interruption of dabigatran before surgery should be based on renal function and bleeding risk 1.

Key Considerations

• The timing of dabigatran discontinuation is crucial to prevent excessive bleeding during surgery, and should be individualized based on the patient's exact renal function, age, and other bleeding risk factors.
• High-risk procedures, such as neurosurgery, cardiac surgery, major abdominal or orthopedic procedures, require longer discontinuation periods due to the increased bleeding risk.
• Bridging anticoagulation is typically not required during the perioperative period for most patients on dabigatran.
• Resumption of dabigatran should occur once adequate hemostasis is achieved, usually 24-72 hours after surgery depending on the procedure's bleeding risk.

Renal Function Considerations

• For patients with normal renal function (CrCl ≥50 mL/min), dabigatran can be discontinued 1-2 days before standard-risk procedures and 2-4 days before high-risk procedures.
• For patients with impaired renal function (CrCl <50 mL/min), dabigatran should be discontinued 3-5 days before standard-risk procedures and at least 5 days before high-risk procedures.

Reversal of Dabigatran

• In cases of emergency surgery or life-threatening bleeding, idarucizumab can be used to reverse the anticoagulant effects of dabigatran 1.
• Idarucizumab is a monoclonal antibody Fab fragment that rapidly reverses the anticoagulation effects of dabigatran, and has been shown to be safe and effective in clinical trials.

From the FDA Drug Label

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 Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required

Dabigatran should be discontinued 1 to 2 days before surgery in patients with normal renal function (CrCl ≥50 mL/min) and 3 to 5 days before surgery in patients with impaired renal function (CrCl <50 mL/min) to minimize the risk of bleeding.

• For patients with normal renal function (CrCl ≥50 mL/min), discontinue dabigatran 1 to 2 days before surgery.
• For patients with impaired renal function (CrCl <50 mL/min), discontinue dabigatran 3 to 5 days before surgery.
• Consider longer times for patients undergoing major surgery or procedures that require complete hemostasis 2.

From the Research

Dabigatran Discontinuation Before Surgery

• Dabigatran, an oral direct factor IIa inhibitor, requires discontinuation before surgery to minimize bleeding risk 3.
• For patients with normal renal function, discontinuing dabigatran 24 hours before standard elective surgery is generally sufficient to normalize the bleeding risk 3, 4.
• In patients with renal impairment, the recommended duration of dabigatran discontinuation is prolonged 3.
• A standardized perioperative dabigatran interruption protocol can be safe and effective, with 80-86% of patients having no residual anticoagulant effect at the time of surgery or procedure 5.

Considerations for Renal Function

• The anticoagulant effect of dabigatran increases with age and in cases of renal failure 6.
• Patients with renal impairment may require a longer duration of dabigatran discontinuation before surgery 3.
• The decision to discontinue dabigatran should be based on the individual patient's renal function and bleeding risk 7.

Bleeding Risk and Management

• The bleeding risk of the scheduled intervention should be considered when deciding whether to discontinue dabigatran 7.
• In patients with a high bleeding risk, dabigatran should be discontinued for a longer period before surgery 3.
• If a bleeding episode occurs, treatment should be based on the severity and localization of the bleeding, and may include delaying the next dabigatran dose or using prothrombin complex concentrates 3.