This case-control study enrolled patients who received POEM at 10 participating centers in Japan, Spain, France, Canada, China, and Greece. All consecutive patients who underwent POEM at study centers before November 2019 were considered for inclusion. Cases were patients receiving antiplatelet and/or anticoagulant therapy before POEM. Patients who underwent POEM at the same institution who were not receiving antiplatelet or anticoagulant drugs were control participants. Investigators matched cases and control participants 1:1 by age and esophageal motility disorder. The primary outcome was safety within 30 days of POEM. Adverse events of interest included bleeding and thromboembolic events. Secondary outcomes included clinical success within 3 to 12 months of procedure and postprocedural rates of gastroesophageal reflux disease (GERD).
Of 2895 patients who underwent POEM at participating centers, 126 (4.4%) were receiving antithrombotic therapy. The final study cohort comprised 126 cases and 126 matched control participants. Of the 126 cases receiving antithrombotic therapy, 103 were receiving antiplatelets, 35 were receiving anticoagulants, and 12 were receiving both. Anticoagulants and clopidogrel were temporarily withdrawn in all cases before POEM. Antiplatelets were withdrawn in 59.5% of cases. Cases and control participants had comparable demographic and clinical features, although cases had a higher number of comorbidities (P <.001) and had more often undergone prior pneumatic balloon dilation (P =.01).
Major bleeding in the 30-day postoperative period was more common in cases compared with control participants (5.6% vs 0.8%; P =.03). Median time to bleeding presentation was 8 (range, 0-19) days. One thromboembolic event occurred in both groups. No POEM-related deaths occurred. Rates of postprocedural success over 3 to 12 months were comparable between cases (91.7%) and control participants (96%). Postprocedural GERD also occurred at similar rates between groups.
According to these results, POEM was not a significant risk in patients on antithrombotic therapy, although increased rates of bleeding were observed. POEM efficacy was also comparable between cases and control participants; however, analyses were not sufficiently powered to detect differences between each antithrombotic drug nor to identify additional risk factors for major bleeding. Further study is necessary to fully elucidate the risks for POEM in patients receiving anticoagulant or antiplatelet therapy.
“POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding,” investigators concluded.
Disclosure: One study author declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
de Santiago ER, Shimamura Y, Pioche M, et al. Safety and effectiveness of peroral endoscopic myotomy in patients on antiplatelet or anticoagulant therapy: an international multicenter case-control study [published online July 24, 2020]. Gastrointest Endosc. doi: 10.1016/j.gie.2020.07.030