The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study enrolled 3007 atrial fibrillation patients treated with apixaban, dabigatran etexilate or rivaroxaban and scheduled for an elective surgery or procedure. A simple standardised perioperative DOAC therapy interruption and resumption strategy based on DOAC pharmacokinetic properties, procedure-associated bleeding risk and creatinine clearance levels was implemented.
The DOAC regimens were omitted for 1 day before a low-bleeding-risk procedure and 2 days before a high-bleeding-risk procedure (4 days for dabigatran in patients with a creatinine clearance <50 mL/min). The DOAC regimens were resumed 1 day after a low-bleeding-risk procedure and 2 to 3 days after a high-bleeding-risk procedure. 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, which is quite significant. In addition, a high proportion of patients (>90% overall; 98.8% of those at high bleeding risk) had a minimal or no residual anticoagulant level at the time of the procedure.
This large prospective cohort validates the most recent international recommendations for the interruption and resumption of DOAC therapy in patients undergoing elective surgery or procedures. As already suggested in current recommendations, no bridging was necessary and coagulation tests were not used to modify the strategy. However, these results can only be discussed in light of the unbalanced proportion of low-bleeding-risk procedures (roughly two thirds) versus high-bleeding-risk procedures (one third).
– Charles-Marc Samama