Results of the PAUSE Study, Perioperative Strategies for Afib Patients

Results from the PAUSE study are shedding new light into the safety of standardized perioperative direct oral anticoagulant (DOAC) management strategies for patients with atrial fibrillation (AF).

The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) study, which contained more than 3000 patients with AF, found that a standardized perioperative management strategy without heparin bridging or measurement of coagulation function was associated with low rates of major bleeding and arterial thromboembolism.

To determine whether a standardized preoperative strategy was safe for patients with AF undergoing surgery or a procedure, investigators conducted a multi center study that included 3007 patients from 23 clinical centers across Canada, Europe, and the United States. Patients included in the study had AF, were 18 years or older, and had to be long-term users of either apixaban, dabigatran etexilate, or rivaroxaban. All patients were scheduled for an elective surgery or procedure and could adhere to the DOAC therapy interruption protocol.

Investigators hypothesized a simple management approach would be safe to use for patient care. For the current study, investigates defined safety as excluding 30-day perioperative rates of major bleeding of 2% and arterial thromboembolism of 1.5%, according to expected outcome rates — defined as 1% for major bleeding and 0.5% for arterial thromboembolism.

The mean age of the study population was 72.5 years and 66.1% (1988) of them were men. Of the 3007 included in the study, 1257 (41.8%) received apixaban, 688 (22.2%) received dabigatran, 1082 (36.0%) received rivaroxaban. Investigators noted that 1007 (33.5%) of patients had a high-bleeding-risk surgery.

Analyses revealed that the overall 30-day postoperative risk of major bleeding was 1.35% (95% CI: 0-2.00%) in the apixaban group, 0.90% (95% CI: 0- 1.73%) in the dabigatran group, and 1.85 (95% CI: 0-2.65%) in the rivaroxaban group.

In regard to arterial thromboembolism, rates of 0.16% (95% CI: 0-0.48%) were observed in the apixaban group, 0.60% (95% CI: 0-1.33%) in the dabigatran group, and 0.37% (95% CI: 0-0.82%) in the rivaroxaban group.

A secondary analysis of patients who adhered to the DOAC therapy interruption and resumption protocols found the 30-day postoperative rate of major bleeding was 1.2% (95% CI: 0-1.89%) in the apixaban group, 1.0% (95% CI: 0-1.93%) in the dabigatran group, and 1.69% (95% CI: 0-2.53%) in the rivaroxaban group. Rates of arterial thromboembolism were 0.19% (95% CI, 0%-0.56%) in the apixaban group, 0.50% (95% CI, 0%-1.25%) in the dabigatran group, and 0.42% (95% CI: 0-0.94%) in the rivaroxaban group.

Based on the results of their study, investigators concluded that use of a standardized perioperative management strategy that did not require use of heparin bridging or preoperative coagulation function testing was associated with low rates of perioperative major bleeding and arterial thromboembolism.

This study, “Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant,” was published online in JAMA Internal Medicine.