AF patients treated with DOACs may have low risk of bleeding and stroke during surgery: JAMA

Atrial fibrillation or Afib patients who are treated with direct oral anticoagulants (DOACs) may have a low risk of bleeding and stroke during surgery revealed a study published in JAMA internal medicine.

Patients with atrial fibrillation (AF) who use a direct oral anticoagulant (DOAC) and request elective surgery or procedure present a common clinical situation yet perioperative management is uncertain. The present study tried to investigate the safety of a standardized perioperative DOAC management strategy.

The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study conducted at 23 clinical centers in Canada, the United States, and Europe enrolled and screened patients from August 1, 2014, through July 31, 2018. A total of 3007 participants had AF; were 18 years of age or older; were long-term users of apixaban, dabigatran etexilate, or rivaroxaban; were scheduled for elective surgery or procedure, and could adhere to the DOAC therapy interruption protocol.

A simple standardized perioperative DOAC therapy interruption and resumption strategy based on DOAC pharmacokinetic properties, procedure-associated bleeding risk, and creatinine clearance levels. The DOAC regimens were omitted for 1 day before a low–bleeding-risk procedure and 2 days before a high–bleeding-risk procedure. The DOAC regimens were resumed 1 day after a low–bleeding-risk procedure and 2 to 3 days after a high–bleeding-risk procedure. Follow-up of patients occurred for 30 days after the operation.

Main outcomes which were considered during this study include major bleeding and arterial thromboembolism (ischemic stroke, systemic embolism, and transient ischemic attack) and the proportion of patients with an undetectable or minimal residual anticoagulant level (<50 ng/mL) at the time of the procedure.

The 3007 patients with AF comprised 1257 in the apixaban cohort, 668 in the dabigatran cohort, and 1082 in the rivaroxaban cohort; 1007 patients had a high–bleeding-risk procedure.

Key Observations

• The 30-day postoperative rate of major bleeding was 1.35% in the apixaban cohort, 0.90% in the dabigatran cohort, and 1.85% in the rivaroxaban cohort.


• The rate of arterial thromboembolism was 0.16% in the apixaban cohort, 0.60% in the dabigatran cohort, and 0.37% in the rivaroxaban cohort.


• In patients with a high–bleeding-risk procedure, the rates of major bleeding were 2.96% in the apixaban cohort and 2.95% in the rivaroxaban cohort.

"In this study, patients with AF who had DOAC therapy interruption for elective surgery or procedure, a perioperative management strategy without heparin bridging or coagulation function testing was associated with low rates of major bleeding and arterial thromboembolism." concluded the authors.

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doi:10.1001/jamainternmed.2019.2431