Abstract 12041: The Risk of Peri-Operative Bleeding with Warfarin Compared to Two Doses of Dabigatran: Results From the RE-LY Trial
Background: The RE-LY trial demonstrated that Dabigatran (Dab) has advantages over warfarin in patients with atrial fibrillation. However; the risk of peri-operative bleeding has not been established.
Methods: In RE-LY, Dab was withheld for 24 hours pre-operatively and resumed when post-operative hemostasis was confirmed. This protocol was then revised for procedures with an increased risk of bleeding, to stop Dab between 2 and 5 days pre-operatively, depending on renal function. The current analysis defined peri-operative as 7 days prior until 30 days following surgery and considered only the first procedure for each patient.
Results: A total of 4615 patients underwent at least one procedure, which included a diagnostic imaging procedure in 30%, pacemaker or ICD 14%, dental surgery 13%, PCI in 3% and CABG in 2%. Their mean age was 76 year, 66% were male and their mean creatinine clearance was 74 ± 27 mL/min. There was no significant difference in the risk of peri-operative major bleeding or other bleeding outcomes between patients receiving either dose of Dab compared to warfarin (Table). Patients in all three arms who had emergency surgery were at much higher risk of peri-operative major bleeding than those having elective surgery (Dab-110: 17.5% vs. 2.7%; Dab-150 17.4% vs. 3.8%; Warfarin: 21.7% vs. 3.3%, p<0.001 for all); however, there were no significant differences between the rate of major bleeding between treatment arms for either type of surgery. Surgery was classified as major (> 1 hour) in 53.5% of cases. In all three treatment arms, major bleeding was more common for major compared to minor surgery (Dab-110 BID: 6.3% vs. 1.9%; Dab-150 BID: 6.4% vs. 3.2% and Warfarin: 8.0% vs. 1.8%; p<0.01 for all). However; there were no significant differences between treatment arms.
Conclusions: There was no increased risk of peri-operative bleeding with either dose of Dab compared to warfarin, even among patients having emergency or major surgery.
- © 2011 by American Heart Association, Inc.