Enrique Rodríguez de Santiago1, Yuto Shimamura2, Mathieu Pioche3, Nikos Eleftheriadis4, Eduardo Albéniz5, Robert Bechara6, Philip Way Yan Chiu7, Carlos Guarner-Argente8, Alberto Herreros de Tejada9, Hugo Uchima10, Yusuke Fujiyoshi2, Thierry Ponchon11, Gonzalo González-Gete5, Simon Hew6, Marianette Murzi-Pulgar8, Virginia Matallana9, Sofía Parejo-Carbonell11, Fermín Estremera-Arévalo5, Frederic Moll3, Manabu Onimaru2, Haruhiro Inoue2. 1. Digestive Diseases Center, Showa University, Koto-Toyosu Hospital, Koto-Ku, Tokyo, Japan; Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain. 2. Digestive Diseases Center, Showa University, Koto-Toyosu Hospital, Koto-Ku, Tokyo, Japan. 3. Service d'Hépato-Gastro-Entérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France. 4. Endoscopy Department Metropolitan Hospital, Athens, Greece. 5. Endoscopy Unit, Gastroenterology Department, Complejo Hospitalario de Navarra, Navarrabiomed Biomedical Research Center, UPNA, IdiSNA, Pamplona, Spain. 6. Queen's University, Division of Gastroenterology, Kingston Health Sciences Centre, Kingston, Ontario, Canada. 7. Department of Surgery, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong. 8. Department of Gastroenterology, Hospital of Santa Creu and Sant Pau, Autonomous University of Barcelona, Barcelona, Spain. 9. Department of Gastroenterology IDIPHISA-Research Institute Segovia Arana Puerta de Hierro University Hospital, Madrid, Spain. 10. Endoscopy Unit, Gastroenterology Department, Hospital Germans Trias I Pujol, Badalona, Barcelona, Spain. 11. Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, IRYCIS, Madrid, Spain.
Abstract
BACKGROUND AND AIMS: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes. METHODS: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30. RESULTS: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases. CONCLUSIONS: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding.
BACKGROUND AND AIMS: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes. METHODS: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30. RESULTS: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases. CONCLUSIONS: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding.