Periendoscopic management of direct oral anticoagulants: A prospective cohort study

F. Radaelli, L. Fuccio, S. Paggi, C. Hassan, A. Repici, E. Rondonotti, R. Semeraro, M. Di Leo, A. Anderloni, A. Amato, C. Trovato, I. Bravi, A. Buda, M. De Bellis, V. D'Angelo, S. Segato, O. Tarantino, A. Musso, R. Fasoli, L. FrazzoniE. Liverani, C. Fabbri, E. Di Giulio, G. Esposito, F. Pigò, A. Iannone, F. Dentali, on behalf of Bowell Group

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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. © Author(s) (or their employer(s)) 2019.
Original languageEnglish
Pages (from-to)969-976
Number of pages8
JournalGut
Volume68
Issue number6
DOIs
Publication statusPublished - 2019

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Keywords

  • bleeding
  • therapeutic endoscopy
  • anticoagulant agent
  • apixaban
  • dabigatran etexilate
  • edoxaban
  • heparin
  • rivaroxaban
  • adult
  • aged
  • Article
  • atrial fibrillation
  • cohort analysis
  • drug safety
  • drug withdrawal
  • female
  • follow up
  • gastrointestinal biopsy
  • gastrointestinal endoscopy
  • gastrointestinal hemorrhage
  • high risk population
  • human
  • human tissue
  • low risk population
  • major clinical study
  • male
  • multicenter study
  • periendoscopy
  • peroperative complication
  • practice guideline
  • priority journal
  • prospective study
  • risk assessment
  • transient ischemic attack
  • venous thromboembolism
  • cerebrovascular accident
  • clinical trial
  • elective surgery
  • Italy
  • middle aged
  • oral drug administration
  • pathophysiology
  • patient safety
  • perioperative period
  • procedures
  • thromboembolism
  • time factor
  • treatment outcome
  • treatment withdrawal
  • Administration, Oral
  • Aged
  • Anticoagulants
  • Cohort Studies
  • Elective Surgical Procedures
  • Endoscopy, Gastrointestinal
  • Female
  • Follow-Up Studies
  • Gastrointestinal Hemorrhage
  • Humans
  • Male
  • Middle Aged
  • Patient Safety
  • Perioperative Care
  • Prospective Studies
  • Risk Assessment
  • Stroke
  • Thromboembolism
  • Time Factors
  • Treatment Outcome
  • Withholding Treatment

Cite this

Radaelli, F., Fuccio, L., Paggi, S., Hassan, C., Repici, A., Rondonotti, E., Semeraro, R., Di Leo, M., Anderloni, A., Amato, A., Trovato, C., Bravi, I., Buda, A., De Bellis, M., D'Angelo, V., Segato, S., Tarantino, O., Musso, A., Fasoli, R., ... Group, O. B. O. B. (2019). Periendoscopic management of direct oral anticoagulants: A prospective cohort study. Gut, 68(6), 969-976. https://doi.org/10.1136/gutjnl-2018-316385