Effect of DOAC Type and DOAC Dose, and Residual DOAC Level on Risk for Perioperative Major Bleeding and Arterial Thromboembolism
ISTH Academy. Douketis J. 07/09/19; 273835; OC 50.1 Topic: Atrial Fibrillation
Dr. James Douketis
Dr. James Douketis
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OC 50.1

Effect of DOAC Type and DOAC Dose, and Residual DOAC Level on Risk for Perioperative Major Bleeding and Arterial Thromboembolism

J. Douketis1, A.C. Spyropoulos2, J. Duncan1, N. Li1, D.M. Arnold1, J.A. Caprini3, K.A. Moffat4, S. Syed5, S. Schulman1,6, PAUSE Study Investigators
1McMaster University, Department of Medicine, Hamilton, Canada, 2The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Medicine, New York, United States, 3NorthShore University Health Systems, Evanston, United States, 4Hamilton Regional Laboratory Medicine Program, McMaster University, Hamilton, Canada, 5McMaster University, Department of Anesthesiology, Hamilton, Canada, 6The First I.M. Sechenov Moscow State Medical, Moscow, Russian Federation

Main Topic: Arterial Thromboembolism
Category: Atrial Fibrillation

Background: The perioperative management of patients with atrial fibrillation (AF) who are taking a direct oral anticoagulant (DOAC) and need elective surgery/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. However, the effect of DOAC type, DOAC dose, and residual level of anticoagulation at the time of surgery/procedure on adverse clinical outcomes is not known.
Aims: To determine the effect of the type of DOAC used by patients, the DOAC dose regimen, and residual pre-operative DOAC levels on perioperative rates of major bleeding (MB) and arterial thromboembolism (ATE).
Methods: We compared, using odds ratios (ORs) and associated 95% confidence intervals (CIs), 30-day postoperative rates of MB and ATE, and residual pre-operative DOAC levels (< 30, 30-49.9, ≥50 ng/mL) in these groups: apixaban (any dose, 5 and 2.5 mg BID); dabigatran (any dose, 150 and 110 mg BID); and rivaroxaban (any dose, 20 and 15 mg QD).
Results: We studied DOAC interruption for elective surgery/procedure in 1257 apixaban, 668 dabigatran and 1082 rivaroxaban patients. Compared to apixaban patients, there was no significant difference in MB rates vs. dabigatran patients (OR=0.66; CI: 0.24-1.60) or rivaroxaban patients (OR=1.37; CI: 0.72-2.67); and no significant difference in ATE rates vs. dabigatran patients (OR=3.78; CI: 0.74-27.3) or rivaroxaban patients (OR=2.33; CI: 0.45-16.8). In the Table below, the DOAC dose had no significant effect on MB and ATE; compared to no residual DOAC level (< 30 ng/mL), a minimal residual level (30-49.9 ng/mL) and elevated level (>50 ng/mL) had no significant effect on MB and ATE rates.
Conclusions: In patients with AF who require perioperative DOAC interruption for an elective surgery/procedure, the DOAC type and dose used, and residual DOAC level did not affect risks for perioperative MB and ATE.

DOAC Dose Regimen Major bleeding n, % (95% CI) & OR (95% CI)† for both doses Arterial Thromboembolism n, % (95% CI) n, % (95% CI) & OR (95% CI)† for both doses
apixaban 5 mg BID n=1004 14, 1.39 (0-2.15) 1.17 (0.32-6.42); p=1.0 0.46 (0.16-1.49); p=0.13 0.25 (0-19.7); p=0.36
  2.5 mg BID n=252 3, 1.19 (0-2.94))   1, 0.4 (0-1.76)  
dabigatran 150 mg BID n=420 4, 0.95 (0-2.1) 1.18 (0.17-13.16); p=1.0 3, 0.71 (0-1.77) 1.78 (0.14-93.6);p=1.0
  110 mg BID n=248 2, 0.81 (0-2.41)   1, 0.4 (0-1.79)  
rivaroxaban 20 mg QD n=900 14, 1.56 (0-2.39) 0.46 (0.16-1.49); p=0.13 3, 0.33 (0- 0.83) 0.6 (0.05-31.78); p=0.52
  15 mg QD n=181 6, 3.31 (0-6.28)   1, 0.55 (0- 2.44)  
Residual DOAC Level (ng/mL):‡ <30 n=2020 27, 1.34 (0-1.83) reference 9, 0.45 (0-0.76) n/a
  30-49.9 n=363 6, 1.65 (0-3.16) 1.24 (0.46-2.83); p=0.64 0, 0 (0-0.74)  
  ≥50 n=158 3, 1.9 (0-4.66) 1.43 (0.34-4.10); p=0.56 0, 0 (0-1.68)  
[DOAC residual pre-operative levels and rates of MB and ATE. Legend: †1-sided; ‡patients with pre-operative DOAC levels measured; n/a, not applicable. ]

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