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CC BY 4.0 · TH Open 2020; 04(03): e255-e262
DOI: 10.1055/s-0040-1716512
Original Article

Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study

Kira MacDougall 
1   Department of Medicine, Northwell Health, Staten Island University Hospital, New York, New York, United States
,
James D. Douketis
2   Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
,
Na Li
2   Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
,
Nathan P. Clark
3   Kaiser Permanente Colorado, Aurora, Colorado, United States
,
Alfonso Tafur
4   Northshore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, United States
,
Julien D'Astous
5   University of Ottawa, Ottawa, Ontario, Canada
,
Joanne Duncan
2   Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
,
Sam Schulman
2   Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
,
Alex C. Spyropoulos
6   Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York, New York, United States
› Author Affiliations Funding The funding agencies are Government of Canada—Canadian Institutes of Health Research; PAUSE ClinicalTrials.gov number, NCT2228798; Heart and Stroke Foundation of Canada, and PAUSE ClinicalTrials.gov number, NCT2228798.
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Abstract

Introduction The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) Study assessed a standardized perioperative management strategy in patients with atrial fibrillation who were taking a direct oral anticoagulant (DOAC) and required an elective surgery or procedure. The aim of this substudy is to analyze the safety of this management strategy across different patient subgroups, according to four presurgical variables: (1) DOAC type and dose, (2) surgery/procedure bleed risk, (3) patient renal function, and (4) age.

Methods Clinical outcomes analyzed included major bleeding (MB), arterial thromboembolism, any bleeding, and any thromboembolism. We used descriptive statistics to summarize clinical outcomes, where the frequency, proportion, and 95% confidence interval were reported. Fisher's exact tests were used for testing the null hypothesis of independence between the clinical outcome and patient characteristic, where the test p-values were reported.

Results There were 3,007 patients with atrial fibrillation requiring perioperative DOAC management. There was no significant difference in bleeding or thromboembolic outcomes according to DOAC type/dose regimen, renal function, or patient age. The rate of MB was significantly higher with high bleed risk procedures than low bleed risk procedures in apixaban-treated patients (2.9 vs. 0.59%; p < 0.01), but not in dabigatran-treated patients (0.88 vs. 0.91%; p = 1.0) or rivaroxaban-treated patients (2.9 vs. 1.3%; p = 0.06). The risk for thromboembolism did not differ according to surgery/procedure-related bleed risk.

Conclusion Our results suggest that in DOAC-treated patients who received standardized perioperative management, surgical bleed risk is an important determinant of bleeding but not thromboembolic outcomes, although this finding was not consistent across all DOACs. There were no differences in bleeding and thromboembolism according to DOAC type and dose, renal function, or age.

Keywords

direct oral anticoagulant - atrial fibrillation - surgery - bleeding - thromboembolism


Publication History

Received: 11 May 2020

Accepted: 04 August 2020

Article published online:
23 September 2020

© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Stuttgart · New York

 

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