In 2019, the American College of Cardiology published guidelines on the use of direct oral anticoagulants (DOACs) for patients with atrial fibrillation (AF). There were 4 main reasons for this: (1) it is not uncommon for inappropriate dosing of DOACs in these patients, (2) nearly 60% of reduced-dose DOAC regimens do not follow guidance from the FDA, (3) inappropriate dosing can be associated with increased risk of cardiovascular hospitalization and/or adverse events like bleeding and all-cause mortality, and (4) underdosing may increase stroke risk, while not reducing rates of major bleeding. The perioperative management of patients with AF who are taking a DOAC and need elective surgery or an elective procedure is a common problem for which management is uncertain. The PAUSE study protocol provides a simple, standardized, DOAC-specific management approach for patients on apixaban, dabigatran, or rivaroxaban. Dr. James Douketis and others sought to better determine the effect of DOAC type, DOAC dose, and residual level of anticoagulation at the time of surgery/procedure on major bleeding (MB) and arterial thromboembolism (ATE).
As Dr. Douketis stated, his team looked at odds ratios and associated 95% confidence intervals, 30-day postoperative rates of MB and ATE, and residual preoperative DOAC levels (apixaban, dabigatran, and rivaroxaban) in 3007 patients. Investigators report that the residual DOAC level at the time of surgery does not appear to affect risk of bleeding. The team found no significant difference in either MB or ATE rates in apixaban patients versus those of dabigatran or rivaroxaban patients. Additionally, the DOAC dose had no significant effect on either MB or ATE. “The clinical implications of this work is that (a) the PAUSE management protocol can be applied across DOAC dose and type used by patients, and that (b) routine measurement of DOAC levels before an elective surgery/procedure is not needed.”