Background: Direct oral anticoagulants (DOACs) have rapid onset of action and washout. Japanese guidelines recommend a one-day cessation of DOACs before colorectal polypectomy. Our previous multicenter trial showed that periprocedural continuation of DOACs did not increase the risk of severe intraprocedural bleeding with cold snare polypectomy (CSP). However, the post-polypectomy bleeding requiring endoscopic hemostasis in the patients continuously taking DOACs was considerably high. We hypothesize that a simplified protocol of one-day cessation of DOACs after polypectomy is safe and effective.

Methods: We conducted a prospective, multicenter, randomized controlled trial in 33 Japanese institutions. Patients taking DOACs and undergoing colonoscopy were randomly assigned in a 1:1 ratio to 1) one-day cessation before (standard group), or 2) one-day cessation after (intervention group) polypectomy. Patients were followed up 28 days after the procedure. Severe bleeding was defined as bleeding requiring surgery, radiological intervention or transfusion, major bleeding as endoscopically controllable bleeding, and minor bleeding as bleeding not requiring endoscopic hemostasis. The primary endpoint was the compound overall incidence of severe intraprocedural bleeding and major delayed bleeding. Secondary endpoints were major intraprocedural and minor delayed bleeding and thromboembolic events.

Results: 368 patients were recruited between June 2020 and June 2022. After excluding patients without polyps and who declined participation, 159 patients with 621 polyps were randomly allocated to the standard group and 155 patients with 625 polyps to the intervention group. Severe intraprocedural bleeding was not observed in either group. Overall incidence of major delayed bleeding was 4.4% [95% Confidential Interval (CI), 2.1 to 8.1] in the standard group compared to 3.2% [95% CI, 1.3 to 6.7] in the intervention group. The inter-group difference was +1.2% [95% CI, -2.4 to 4.7], showing non-inferiority with one-day cessation of DOACs after polypectomy compared to the standard practice. Major intraprocedural bleeding was significantly higher in the intervention group (44/625, 7.0%) compared to standard group (21/621, 3.4%), but all of them were managed easily. However, minor delayed bleeding was seen more frequently in the standard group (10/159, 6.3%) than in the intervention group (6/155, 3.9%). Among the 128 patients (41%) who underwent cold polypectomy only, major delayed bleeding was observed at 1.6% in the standard group, but none in the intervention group. There was no thromboembolic event during the study period.

Conclusion: Considering the pharmacokinetics of DOACs, a one-day cessation before colonoscopy may not be necessary, and employing a one-day cessation after polypectomy is a feasible approach to the periprocedural management of DOACs.

Schedules of periprocedural management of DOACs in both groups.

Results

Shinjiro Yamaguchi

Appearances