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Original article
Periendoscopic management of direct oral anticoagulants: a prospective cohort study
  1. Franco Radaelli1,
  2. Lorenzo Fuccio2,
  3. Silvia Paggi1,
  4. Cesare Hassan3,
  5. Alessandro Repici4,
  6. Emanuele Rondonotti1,
  7. Rossella Semeraro4,
  8. Milena Di Leo4,
  9. Andrea Anderloni4,
  10. Arnaldo Amato1,
  11. Cristina Trovato5,
  12. Ivana Bravi5,
  13. Andrea Buda6,
  14. Mario de Bellis7,
  15. Valentina D’Angelo7,
  16. Sergio Segato8,
  17. Ottaviano Tarantino9,
  18. Alessandro Musso10,
  19. Renato Fasoli11,
  20. Leonardo Frazzoni2,
  21. Elisa Liverani2,
  22. Carlo Fabbri12,
  23. Emilio Di Giulio13,
  24. Gianluca Esposito13,
  25. Flavia Pigò14,
  26. Andrea Iannone15,
  27. Francesco Dentali16
  28. on behalf of Bowell Group
  1. 1 Gastroenterology Unit, Valduce Hospital, Como, Italy
  2. 2 Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
  3. 3 Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy
  4. 4 Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research and University Hospital, Rozzano, Milan, Italy
  5. 5 Digestive Endoscopy Unit, European Institute of Oncology, Milan, Italy
  6. 6 Gastroenterology Unit, Santa Maria del Prato Hospital, Feltre, Italy
  7. 7 Gastroenterology and Endoscopy Unit, Department of Abdominal Oncology, Istituto Nazionale Tumori – IRCCS – Fondazione G. Pascale, Naples, Italy
  8. 8 Gastroenterology and GI Endoscopy Unit, Ospedale di Circolo e Fondazione Macchi, Varese, Italy
  9. 9 Gastroenterology Unit, S. Giuseppe Hospital, Empoli, Italy
  10. 10 Gastroenterology Unit, Città della Salute e della Scienza, Turin, Italy
  11. 11 Digestive Endoscopy Unit, ASL 1 Liguria, Imperia Hospital, Imperia, Italy
  12. 12 Gastroenterology and Digestive Endoscopy Unit, AUSL Bologna Bellaria-Maggiore Hospital, Bologna, Italy
  13. 13 Department of Medical-Surgical Sciences and Translational Medicine, Sant’Andrea Hospital, Sapienza University, Rome, Italy
  14. 14 Gastroenterology and Digestive Endoscopy Unit, S. Agostino-Estense Hospital, Modena, Italy
  15. 15 Gastroenterology Unit, University of Bari, Bari, Italy
  16. 16 Department of Clinical Medicine, University of Insubria, Varese, Italy
  1. Correspondence to Dr Franco Radaelli, Division of Digestive Endoscopy and Gastroenterology, Valduce Hospital, 22100 Como, Italy; francoradaelli01{at}gmail.com

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.

  • therapeutic endoscopy
  • bleeding
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Footnotes

  • Contributors FR, CH, AR and FD: study concept and design, interpretation of results and critical revision of the article; FR and SP: drafting of the manuscript. FR, LF, SP and FD: interpretation of results and statistical analysis. FR, SP, MDL, AnA, CT, IB, AB, MdB, VD, SS, AM, ArA, ER, OT, RF, LF, EL, CF, EDG, GE, FP and AI: acquisition of data, critical revision of the article for important intellectual content and final approval of the article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests FR received grants outside the submitted work from BMS/Pfizer and Boehringer Ingelheim. FD received grants outside the submitted work from BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Roche and Sanofi.

  • Patient consent Obtained.

  • Ethics approval Ethical Committee, Valduce Hospital, Como, Italy.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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