James Douketis, MD, McMaster University, Hamilton, Ontario, discusses the the PAUSE (the Perioperative Anticoagulant Use for Surgery Evaluation) study, in which researchers found that patients with atrial fibrillation taking direct oral anticoagulants (DOACs) were able to safely stop taking them before and after elective surgeries and other invasive procedures.
Dr. Douketis and his colleagues found that patients could stop taking DOACs a day before and a day after a procedure with low bleeding risk, and two days before and after a high bleeding-risk procedure, without clinically concerning risk for arterial thromboembolism or major bleeding.
The aim of the PAUSE study was to develop a safe, standardized, and easy-to-use DOAC perioperative management approach during the period before and after a procedure or surgery.
Douketas and his colleagues prospectively evaluated 3,007 Afib patients from 23 sites across the U.S., Canada, and Europe, 1,257 of whom were taking apixaban (Eliquis), 1,082 rivaroxaban (Xarelto), and 668 dabigatran (Pradaxa).
The study cohort was 66.1% male, mean age 72.5, with a mean 33.5% risk for bleeding associated with surgery or other procedures.
A standardized protocol including DOAC pharmacokinetic properties, procedure-associated bleeding risk and creatinine clearance was used to manage patients. DOAC use was stopped a day before and resumed a day after low-bleed procedures such as a colonoscopy or hernia repair, and stopped two days before and resumed two days after a high-risk surgery, such as cancer, heart or orthopedic surgery, or procedures involving a spinal anesthetic.
The protocol excluded both heparin bridging and preoperative coagulation testing. Thirty-day postoperative rates of major bleeding were 1.35% (95% CI 0%-2.00%) in the apixaban cohort, 0.90% (95% CI 0%-1.73%) in the dabigatran cohort, and 1.85% (95% CI 0%-2.65%) in the rivaroxaban cohort.
Fewer than 1% of patients experienced a blood clot, with rates of 0.16% (95% CI 0%-0.48%) in the apixaban cohort, 0.6% (95% CI 0%-1.33%) in the dabigatran cohort, and 0.37% (95% CI 0%-0.82%) in the rivaroxaban cohort.
Of the 2,541 patients who had preoperative DOAC levels measured, more than 90% had minimal or no coagulant left in their blood (50 ng/mL) at the time of surgery, with 90.5% of patients in the apixaban cohort, 95.1% of patients in the dabigatran cohort, and 96.8% of patients in the rivaroxaban cohort.