Clinical equipoise and patient preferences for DOAC resumption after high-risk endoscopy: implications for a randomized trial
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The optimal timing of resuming direct oral anticoagulants (DOACs) after high-risk endoscopic procedures remains uncertain. Existing recommendations are largely based on expert opinion, resulting in substantial practice variability. Understanding clinician equipoise and patient preferences is essential to inform the design of randomized trials, including the proposed Resumption of Direct Oral Anticoagulants After High-Risk Endoscopy (RESUME) trial.
Methods
We conducted parallel, cross-sectional surveys of practicing endoscopists and patients with atrial fibrillation using electronic questionnaires administered via Qualtrics. The endoscopist survey, distributed through the American Society for Gastrointestinal Endoscopy, assessed practice patterns, acceptability of early (postoperative day [POD] +1), intermediate (POD +3), and late (POD +5) resumption strategies, and perceptions of clinical equipoise. The patient survey, distributed through two advocacy organizations, evaluated awareness of evidence gaps and prioritization of bleeding versus thromboembolic risk.
Results
A total of 201 endoscopists and 477 patients (92.5% taking a DOAC) were included. Endoscopists demonstrated wide variability in preferred timing of DOAC resumption after a standardized high-risk mucosal resection vignette, ranging from same-day resumption to delays beyond five days. POD +2 was the most commonly selected strategy, and most respondents rated more than one proposed RESUME trial arm as acceptable. Nearly all endoscopists (98.9%) rated a randomized trial to determine optimal timing as important. Patient preferences regarding bleeding versus stroke risk were heterogeneous and symmetrically distributed around the neutral response on a five-point ordinal scale. Preferences did not differ by prior stroke or transient ischemic attack, prior major bleeding, age, sex, or geographic region. More than half of patients reported confidence that clear guidance exists regarding DOAC resumption, despite the absence of high-quality randomized evidence informing postprocedural timing.
Conclusions
Both clinicians and patients demonstrate substantial variability and clinical uncertainty regarding optimal timing of DOAC resumption after high-risk endoscopy, supporting the ethical justification, feasibility, and relevance of the proposed RESUME trial.
