Safety and effectiveness of peroral endoscopic myotomy in patients on antiplatelet or anticoagulant therapy: an international multicenter case-control study

      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.

      Abbreviations:

      AE (adverse event), CI (confidence interval), DOAC (direct oral anticoagulant), LMWH (low-molecular-weight heparin), POEM (peroral endoscopic myotomy), STROBE (Strengthening the Reporting of Observational studies in Epidemiology)
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      References

        • Oude Nijhuis R.
        • Zaninotto G.
        • Roman S.
        • et al.
        European Guideline on Achalasia – UEG and ESNM recommendations.
        United European Gastroenterol J. 2020; 8: 13-34
        • Werner Y.B.
        • Hakanson B.
        • Martinek J.
        • et al.
        Endoscopic or surgical myotomy in patients with idiopathic achalasia.
        N Engl J Med. 2019; 381: 2219-2229
        • Ponds F.A.
        • Fockens P.
        • Lei A.
        • et al.
        Effect of peroral endoscopic myotomy vs pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: a randomized clinical trial.
        JAMA. 2019; 322: 134-144
        • Von Renteln D.
        • Fuchs K.-H.
        • Fockens P.
        • et al.
        Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study.
        Gastroenterology. 2013; 145: 309-311.e1-3
        • Inoue H.
        • Minami H.
        • Kobayashi Y.
        • et al.
        Peroral endoscopic myotomy (POEM) for esophageal achalasia.
        Endoscopy. 2010; 42: 265-271
        • Shiwaku H.
        • Inoue H.
        • Sato H.
        • et al.
        Peroral endoscopic myotomy for achalasia: a prospective multicenter study in Japan.
        Gastrointest Endosc. 2020; 91: 1037-1044.e2
        • Shiwaku H.
        • Inoue H.
        • Onimaru M.
        • et al.
        Multicenter collaborative retrospective evaluation of peroral endoscopic myotomy for esophageal achalasia: analysis of data from more than 1300 patients at eight facilities in Japan.
        Surg Endosc. 2020; 34: 464-468
        • Rodríguez de Santiago E.
        • Mohammed N.
        • Manolakis A.
        • et al.
        Anterior versus posterior myotomy during poem for the treatment of achalasia: systematic review and meta-analysis of randomized clinical trials.
        J Gastrointest Liver Dis. 2019; 28: 107-115
        • Chen Y.-I.
        • Inoue H.
        • Ujiki M.
        • et al.
        An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians.
        Gastrointest Endosc. 2018; 87: 956-961
        • von Elm E.
        • Altman D.G.
        • Egger M.
        • et al.
        The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.
        J Clin Epidemiol. 2008; 61: 344-349
        • Benech N.
        • Pioche M.
        • O’Brien M.
        • et al.
        Esophageal hematoma after peroral endoscopic myotomy for achalasia in a patient on antiplatelet therapy.
        Endoscopy. 2015; 47: E363-E364
        • Kahrilas P.J.
        • Bredenoord A.J.
        • Fox M.
        • et al.
        The Chicago Classification of esophageal motility disorders, v3.0.
        Neurogastroenterol Motil. 2015; 27: 160-174
        • Haito-Chavez Y.
        • Inoue H.
        • Beard K.W.
        • et al.
        comprehensive analysis of adverse events associated with per oral endoscopic myotomy in 1826 patients: an international multicenter study.
        Am J Gastroenterol. 2017; 112: 1267-1276
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Acosta R.D.
        • Abraham N.S.
        • Chandrasekhara V.
        • et al.
        • ASGE Standards of Practice Committee
        The management of antithrombotic agents for patients undergoing GI endoscopy.
        Gastrointest Endosc. 2016; 83: 3-16
        • Veitch A.M.
        • Vanbiervliet G.
        • Gershlick A.H.
        • et al.
        Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines.
        Gut. 2016; 65: 374-389
        • Kato M.
        • Uedo N.
        • Hokimoto S.
        • et al.
        Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 appendix on anticoagulants including direct oral anticoagulants.
        Dig Endosc. 2018; 30: 433-440
        • Kuo C.-L.
        • Duan Y.
        • Grady J.
        Unconditional or conditional logistic regression model for age-matched case-control data?.
        Front Public Health. 2018; 6: 57
        • Li Q.-L.
        • Zhou P.-H.
        • Yao L.-Q.
        • et al.
        Early diagnosis and management of delayed bleeding in the submucosal tunnel after peroral endoscopic myotomy for achalasia (with video).
        Gastrointest Endosc. 2013; 78: 370-374
        • Ren Z.
        • Zhong Y.
        • Zhou P.
        • et al.
        Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases).
        Surg Endosc. 2012; 26: 3267-3272
        • Takizawa K.
        • Oda I.
        • Gotoda T.
        • et al.
        Routine coagulation of visible vessels may prevent delayed bleeding after endoscopic submucosal dissection--an analysis of risk factors.
        Endoscopy. 2008; 40: 179-183
        • Radaelli F.
        • Fuccio L.
        • Paggi S.
        • et al.
        Periendoscopic management of direct oral anticoagulants: a prospective cohort study.
        Gut. 2019; 68: 969-976
        • Tien A.
        • Kwok K.
        • Dong E.
        • et al.
        Impact of direct-acting oral anticoagulants and warfarin on postendoscopic GI bleeding and thromboembolic events in patients undergoing elective endoscopy.
        Gastrointest Endosc. 2020; 92: 284-292.e2
        • Nagata N.
        • Yasunaga H.
        • Matsui H.
        • et al.
        Therapeutic endoscopy-related GI bleeding and thromboembolic events in patients using warfarin or direct oral anticoagulants: results from a large nationwide database analysis.
        Gut. 2018; 67: 1805-1812
        • Douketis J.D.
        • Healey J.S.
        • Brueckmann M.
        • et al.
        Perioperative bridging anticoagulation during dabigatran or warfarin interruption among patients who had an elective surgery or procedure. Substudy of the RE-LY trial.
        Thromb Haemost. 2015; 113: 625-632
        • Sedgwick P.
        Case-control studies: advantages and disadvantages.
        BMJ. 2014; 348: f7707

      Linked Article

      • Contemporary management of antithrombotic agents for patients undergoing peroral endoscopic myotomy
        Gastrointestinal EndoscopyVol. 93Issue 4
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          Achalasia is a rare disorder with an estimated incidence rate of 0.3 to 1.63 per 100,000 person years.1 Since the first peroral endoscopic myotomy (POEM) was performed in 2008, POEM has become increasingly accepted as first-line therapy for achalasia because of its high clinical efficacy and low adverse event rates.2 However, despite the multitude of publications now emerging, an aspect that remains unclear is the perioperative management and risks associated with the use of antithrombotic agents.
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