T h e n e
What was the primary end point in the trial comparing POEM and LHM plus Dor's fundoplication?
Apuntes
T h e n e w e ng l a n d j o u r na l o f m e dic i n en engl j med 381;23 nejm.org December 5, 2019 2219 The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Rösch at the Department of Interdisci- plinary Endoscopy, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany, or at t.roesch@uke.de. N Engl J Med 2019;381:2219-29. DOI: 10.1056/NEJMoa1905380 Copyright © 2019 Massachusetts Medical Society. BACKGROUND Pneumatic dilation and laparoscopic Heller’s myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODS In a multicenter, randomized trial, we compared POEM with LHM plus Dor’s fundoplica- tion in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indi- cating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of −12.5 percentage points was used in the pri- mary analysis. Secondary end points included adverse events, esophag...
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