Is it okay to hold Dabigatran (Pradaxa) in a patient with a history of pulmonary embolism (PE)?

Temporary Discontinuation of Dabigatran in Patients with History of Pulmonary Embolism

Temporarily holding dabigatran in a patient with a history of pulmonary embolism should be avoided unless absolutely necessary due to the increased risk of thrombotic events. 1

Risks of Discontinuing Dabigatran

• The FDA label for dabigatran explicitly warns that premature discontinuation increases the risk of thrombotic events, including recurrent pulmonary embolism 1
• If dabigatran must be discontinued for a reason other than pathological bleeding or completion of therapy, coverage with another anticoagulant should be considered 1

Considerations Based on PE Risk Factors

For patients with high-risk features:

• Patients with recurrent VTE (at least one previous episode of PE or DVT) have a Class I recommendation for indefinite oral anticoagulation 2
• Patients with a first episode of PE and no identifiable risk factor should be considered for extended anticoagulation of indefinite duration (Class IIa recommendation) 2
• Patients with a first PE associated with a persistent risk factor should also be considered for indefinite anticoagulation (Class IIa recommendation) 2

For patients with lower-risk features:

• Patients with a first PE secondary to a major transient/reversible risk factor may discontinue therapeutic anticoagulation after 3 months (Class I recommendation) 2
• Even for patients with a first PE associated with a minor transient risk factor, extended anticoagulation should be considered (Class IIa recommendation) 2

Management Options When Temporary Interruption is Necessary

If dabigatran must be temporarily discontinued:

• Consider bridging therapy with LMWH or UFH for high-risk patients 2
• For patients with absolute contraindications to anticoagulation, inferior vena cava filters should be considered (Class IIa recommendation) 2
• The timing of discontinuation should account for the elimination half-life of dabigatran and the patient's renal function 1

Special Considerations

• Case reports have documented bilateral pulmonary emboli occurring in patients on dabigatran therapy, highlighting that even patients on anticoagulation can develop PE 3, 4
• Regular reassessment of drug tolerance, adherence, hepatic and renal function, and bleeding risk is recommended for patients on extended anticoagulation (Class I recommendation) 2

Common Pitfalls and Caveats

• Failing to provide alternative anticoagulation when dabigatran is discontinued 1
• Not recognizing that the risk of recurrent VTE remains even after the initial treatment period 2
• Overlooking the need for extended or indefinite anticoagulation in patients with unprovoked PE or persistent risk factors 2
• Not considering patient-specific factors such as renal function, which affects dabigatran clearance 1

Remember that the decision to temporarily discontinue dabigatran must carefully weigh the risk of thrombotic events against the reason for discontinuation. If discontinuation is necessary, appropriate bridging therapy should be implemented to minimize the risk of recurrent pulmonary embolism.