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Perioperative Management of DOACs in Atrial Fibrillation
Study Questions:
What is the safety of a standardized perioperative direct oral anticoagulant (DOAC) management strategy?
Methods:
The authors conducted the PAUSE (Perioperative Anticoagulation Use for Surgery Evaluation) cohort study at 23 centers in Canada, the United States, and Europe for patients with atrial fibrillation (AF) taking apixaban, dabigatran, or rivaroxaban and undergoing a surgical procedure between 2014-2018. If the DOAC required temporary interruption for the surgical procedure, the patient was advised to stop the DOAC 1 day before a low-bleeding-risk procedure and 2 days before a high-bleeding risk procedure (2 and 3 days, respectively for dabigatran-treated patients with creatinine clearance <50 ml/min). The DOAC was to be restarted 1 day following low-bleeding-risk procedures and 2-3 days following high-bleeding-risk procedures. Outcomes assessed included 30-day bleeding and thromboembolic event. Anticoagulant level was assessed using a drug-specific anti-Xa (apixaban or rivaroxaban) or dilute thrombin time (dabigatran) preprocedure, but this result was not available for clinical decision making.
Results:
Among the 3,007 patients enrolled (mean [standard deviation] age 72.5 [9.39] years, 66.1% men), 1,007 (33.5%) underwent a high-bleed-risk procedure. Deviation from pre- and postprocedure protocol management occurred in 383 (12.7%) patients. The 30-day postoperative rate of major bleeding was 1.35% (95% confidence interval [CI], 0-2.00%) for apixaban-treated patients, 0.90% (95% CI, 0-1.73%) for dabigatran-treated patients, and 1.85% (95% CI, 0-2.65%) for rivaroxaban-treated patients. Among patients undergoing high-bleeding-risk procedures, the rate of major bleeding was 2.95% (95% CI, 0-4.68%) in the apixaban cohort, 0.88% (95% CI, 0-2.62%) in the dabigatran cohort, and 2.95% (95% CI, 0-4.76%) in the rivaroxaban cohort. The rate of arterial thromboembolism was 0.16% (95% CI, 0-0.48%) in the apixaban cohort, 0.60% (95% CI, 0-1.33%) in the dabigatran cohort, and 0.37% (95% CI, 0-0.82%) in the rivaroxaban cohort. Among the 2,541 (84.5%) patients with a preprocedure DOAC treatment level, levels of <50 ng/ml were found in 90.5% of apixaban-treated patients, 95.1% of dabigatran-treated patients, and 96.8% of rivaroxaban-treated patients.
Conclusions:
The authors concluded that patients with AF who had a standardized DOAC interruption for elective surgery experienced a low rate of major bleeding and arterial thromboembolism.
Perspective:
Since the DOAC medications were first introduced in 2010, clinicians have struggled with perioperative management given a lack of evidence-based, standardized protocols. The PAUSE study, presented here, is the first large-scale study to provide safety evidence for the three most commonly used DOAC medications (apixaban, dabigatran, and rivaroxaban). While the authors’ initial hypothesis of a <2.0% rate of major bleeding was not quite met for the apixaban and rivaroxaban cohorts, the overall major bleeding rates were still quite low when using this simple management strategy. Controversy remains regarding how best to manage DOACs in patients receiving neuraxial anesthesia. The PAUSE study included 230 (7.6%) and further analysis of this subcohort will be beneficial. In the meantime, anesthesia guidelines generally favor longer interruptions (3-5 days) than were used in the PAUSE study before neuraxial anesthesia. Otherwise, the PAUSE study provides the best evidence for safe perioperative management and should be adopted broadly for DOAC-treated patients.
Keywords: Anesthesia, Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Creatinine, Hemorrhage, Heparin, Low-Molecular-Weight, Perioperative Period, Secondary Prevention, Elective Surgical Procedures, Thrombin Time, Thromboembolism, Vascular Diseases
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