Objective
To assess the frequency of adverse events associated with
periendoscopic management of direct oral anticoagulants (DOACs) in
patients undergoing elective GI endoscopy and the efficacy and safety of
the British Society of Gastroenterology (BSG) and European Society of
Gastrointestinal Endoscopy (ESGE) recommendations (NCT
02734316).
Design
Consecutive patients on DOACs scheduled for elective GI endoscopy
were prospectively included. The timing of DOAC interruption and
resumption before and after the procedures were recorded, along with
clinical and procedural data. Procedures were stratified into low-risk
and high-risk for GI-related bleeding, and patients into low-risk and
high-risk for thromboembolic events. Patients were followed-up for 30
days for major and clinically relevant non-major bleeding events
(CRNMB), arterial and venous thromboembolism and death.
Results
Of 529 patients, 38% and 62% underwent high-risk and low-risk
procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%)
major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic
events (transient ischaemic attacks). Overall, the incidence of bleeding
events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in
low-risk and high-risk procedures, respectively. For high-risk
procedures, the incidence of intraprocedural bleeding was similar in
patients who interrupted anticoagulation according to BSG/ESGE
guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower
risk as compared with those who stopped anticoagulation later
(10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar
in patients who resumed anticoagulation according to BSG/ESGE guidelines
or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was
resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major
bleeding was significantly higher in patients receiving heparin bridging
than in non-bridged ones (26.6%vs5.9%, p=0.017).
Conclusion
High-risk procedures in patients on DOACs are associated with a
substantial risk of bleeding, further increased by heparin bridging.
Adoption of the BSG/ESGE guidelines in periendoscopic management of
DOACs seems to result in a favourable benefit/risk ratio.
Trial registration number
NCT
02734316; Pre-results.