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PAUSE-2 Randomized Pilot Trial to Compare Two Strategies (PAUSE vs. ASRA) for Perioperative DOAC Management

J. Douketis, J. Duncan, M. St John, P. Gross, S. Schulman

McMaster University, Hamilton, Ontario, Canada

Abstract Number: OC 71.2

Meeting: ISTH 2022 Congress

Theme: Arterial Thromboembolism » Atrial Fibrillation

Background: There is uncertainty about how to manage patients taking a direct oral anticoagulant (DOAC) who need a high-bleed-risk surgery/neuraxial anesthesia. There are two possible strategies: (i) PAUSE management, derived from the PAUSE study, requires DOAC interruption for 2 days before and after a high-bleed-risk surgery/neuraxial procedure, without heparin bridging or DOAC level testing; (ii) ASRA management, derived from the American Society of Regional Anesthesia guidelines, requires DOAC interruption for 3-5 days, resumption within 24 hours post-op and heparin bridging and DOAC levels in selected patients.

Aims: This pilot study aims to assess feasibility of a larger RCT and to identify possible safety signal concerns in either strategy.

Methods: PAUSE-2 pilot is an open-label, randomized controlled trial (RCT) that compares the PAUSE vs. ASRA strategy for perioperative DOAC management in patients with atrial fibrillation needing a high-bleed-risk surgery/neuraxial anesthesia. We hypothesize that PAUSE management will be as safe as ASRA for the outcomes of major bleeding (2.5% both arms, 2% non-inferiority [NI] margin) and stroke/systemic embolism (0.5% both arms, 1% NI margin). A secondary outcome is residual DOAC levels, measured just before surgery. Patients are followed from randomization (3-5 days pre-surgery) until 30 days post-surgery. PAUSE-2 was approved by local research ethics boards; 80% of eligible patients consented to participate.

Results: As of January 28, 2022, 90 recruited patients from 3 clinical sites completed the 30-day follow-up. The patient/surgery characteristics are shown in Table 1. In a blinded analysis of all patients, there was no stroke/systemic embolism, major bleeding or deaths. One patient had a pulmonary embolism. Results of residual DOAC levels are ongoing, to be disclosed at the time of public presentation.

Conclusion(s): The PAUSE-2 pilot RCT demonstrates feasibility to conduct a large, adequately-powered trial. It successfully randomized patients to two perioperative DOAC management strategies, and does not appear to have safety signal concerns.

Table 1

PAUSE-2 RCT Pilot Patient/Surgery Characteristics

To cite this abstract in AMA style:

Douketis J, Duncan J, St John M, Gross P, Schulman S. PAUSE-2 Randomized Pilot Trial to Compare Two Strategies (PAUSE vs. ASRA) for Perioperative DOAC Management [abstract]. https://abstracts.isth.org/abstract/pause-2-randomized-pilot-trial-to-compare-two-strategies-pause-vs-asra-for-perioperative-doac-management/. Accessed August 16, 2022.

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