Periendoscopic management of direct oral anticoagulants: a prospective cohort study

Abstract

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.

Periprocedural Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant Undergoing a Digestive Endoscopy

“…Of importance, only 1 of the 4 events was adjudicated as related to the periprocedural DOAC interruption (0.18%), with the other 3 events occurring 11–24 days after DOAC resumption. Reported thromboembolic risks in anticoagulated patients undergoing elective endoscopy reached 5.4% in a nationwide Japanese cohort (25), although lower 30-day thromboembolic rates more in keeping with our findings were reported in an Italian cohort of 529 patients (0.4%) (26) and a Spanish cohort of 598 patients (0.7%) (27).…”

“…Indeed, the endoscopies performed in the PAUSE cohort included a large proportion of gastroscopies and colonoscopies with what were likely diagnostic procedures with or without biopsies and the removal of small colonic polyps. These are procedures that are associated with a low risk of bleeding, even in anticoagulated patient population (26,27,34–36), in contrast to higher-risk endoscopies such as endoscopic retrograde cholangiopancreatography and endoscopic submucosal dissection (22,25,26,32,33,37,38). Again, the lack of detailed intraprocedural information and scarcity of patients undergoing more sophisticated advanced endoscopic procedures does not allow our PAUSE subanalysis data to further inform guidelines on this aspect of management.…”

“…The incidence of bleeding events, although similar to some reports (29), most of whom addressed postpolypectomy bleeding (30,31), was lower than that reported in most large cohorts of patients on DOAC undergoing a wide range of endoscopic procedures (6.7%-9.9%). This discrepancy may be because of the performance of higher-risk procedures and the use of heparin bridging in the latter (25,26,32,33). Indeed, the endoscopies performed in the PAUSE cohort included a large proportion of gastroscopies and colonoscopies with what were likely diagnostic procedures with or without biopsies and the removal of small colonic polyps.…”

Improving documentation of anticoagulation and antiplatelet recommendations after outpatient endoscopy

“…Given the importance of well-documented postprocedure AC/AP instruction on discharge from hospital settings,2 3 these interventions should inform best practice quality guidelines for outpatient endoscopic procedures 13. These interventions, which require low-resource utilisation, could also be part of standardised processes readily implemented at other institutions to help potentially reduce postprocedure patient confusion, medication errors and possible complications 6 8 9 13…”

“…Evidence suggests that up to 5% of hospitalisations for acute coronary syndrome may be due to prolonged discontinuation of AP therapy after non-cardiovascular procedures 6. Conversely, clinically relevant bleeding events after high-risk endoscopic interventions may be as high as 20%, especially if AC/AP is resumed prematurely 8 9. While professional societies have previously developed recommendations to help mitigate the risks surrounding postprocedure management of AC/AP agents, there is no literature evaluating how often these recommendations are provided to patients after routine outpatient endoscopy.…”