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Thromb Haemost. 2017 Dec;117(12):2415-2424. doi: 10.1160/TH17-08-0553. Epub 2017 Dec 6.

The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study for Patients on a Direct Oral Anticoagulant Who Need an Elective Surgery or Procedure: Design and Rationale.

Author information

1
Department of Medicine, McMaster University, Hamilton, Canada.
2
Department of Medicine, Hofstra Northwell School of Medicine, Northwell Health at Lenox Hill Hospital, New York, New York, United States.
3
Department of Medicine, University of Edinburgh, Edinburgh, United Kingdom.
4
Department of Medicine, McGill University, Montreal, Canada.
5
Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
6
NorthShore University Health Systems, Evanston, Illinois, United States.
7
Department of Pharmacy, Kaiser Permanente Colorado, Aurora, Colorado, United States.
8
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
9
Department of Medicine and Surgery, Insubria University, Varese, Italy.
10
Department of Medicine, Université de Montréal, Montreal, Canada.
11
Department of Anesthesiology, University of Manitoba, Winnipeg, Canada.
12
Department of Medicine, University of British Columbia, Vancouver, Canada.
13
L'Institut du Savoir Montfort, L'Hopital Monfort, Ottawa, Ontario, Canada.
14
Department of Internal Medicine, Centre Hospitalier Universitaire de Sherbrooke, Quebec, Canada.
15
Department of Medicine, University of Calgary, Calgary, Canada.
16
Department of Medicine, Henry Ford Hospital, Detroit, Michigan, United States.
17
Department of Medicine, Dalhousie University, Halifax, Canada.
18
Department of Anesthesiology, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
19
Department of Cardiovascular Sciences, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
20
Institute for Immunology and Transfusion Medicine, Universitätsmedizin Greifswald, Greifswald, Germany.
21
Department of Medicine, University of Alberta, Edmonton, Canada.
22
Department of Medicine, University of Toronto, Toronto, Canada.

Abstract

Background The perioperative management of patients who take a direct oral anticoagulant (DOAC) for atrial fibrillation and require treatment interruption for an elective surgery/procedure is a common clinical scenario for which best practices are uncertain. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study is designed to address this unmet clinical need. We discuss the rationale for the PAUSE design and analysis plan as well as the rationale supporting the perioperative DOAC protocol. Methods PAUSE is a prospective study with three parallel cohorts, one for each DOAC, to assess a standardized but patient-specific perioperative management protocol for DOAC-treated patients with atrial fibrillation. The perioperative protocol accounts for DOAC type, patient's renal function and surgery/procedure-related bleeding risk. The primary study aim is to demonstrate the safety of the PAUSE protocol for the perioperative management of each DOAC. The secondary aim is to determine the effect of the pre-procedure interruption on residual anticoagulation when measured by the dilute thrombin time for dabigatran and anti-factor Xa levels for rivaroxaban and apixaban. The study hypothesis is that the perioperative management protocol for each DOAC is safe for patient care, defined by expected risks for major bleeding of 1% (80% power to exclude 2%), and for arterial thromboembolism of 0.5% (80% power to exclude 1.5%) in each DOAC group. Conclusion The PAUSE study has the potential to establish a standard-of-care approach for the perioperative management of DOAC-treated patients. The PAUSE management protocol is designed to be easily applied in clinical practice, as it is standardized and also patient specific.

PMID:
29212129
DOI:
10.1160/TH17-08-0553
[Indexed for MEDLINE]

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