ENDOSCOPIC VS. SURGICAL MYOTOMY IN PATIENTS WITH IDIOPATHIC ACHALASIA – FIVE-YEAR FOLLOW UP OF A RANDOMISED TRIAL

BACKGROUND
Endoscopic myotomy (POEM) was shown equally effective as laparoscopic Heller myotomy (LHM) in patients with achalasia at two years in a multicenter randomized trial. Postprocedural reflux esophagitis and treatment with acid inhibitors were more frequent after POEM. Here we report treatment success rate and analysis of post-procedural reflux at the five-year follow-up.

METHODS
In a multicenter, randomized trial, we compared POEM with LHM plus Dor’s fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less without the use of additional treatments at the 5-year follow-up. Secondary end points included esophageal function (manometry, pH-metry), Gastrointestinal Quality of Life Index score, rate of reflux esophagitis and its complications and proportion of patients on proton pump inhibitors.

RESULTS
A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor’s fundoplication (109 patients). Five-year follow up data was available in 90 POEM and 86 LHM patients. Clinical success rate at the 5-year follow-up was 75.0% (95% CI: 66.2% to 82.1%) in the POEM group and 70.8% (95% CI: 61.7% to 78.5%) in the LHM group. The difference of 4.2% (95% CI: -7.5% to 15.7%) indicates non-inferiority of POEM at the pre-defined 12.5% margin. Decrease in integrated relaxation pressure of the lower esophageal sphincter at 5 years did not differ between the treatment groups (difference, 0.9 mm Hg; 95% CI, -4.3 to 6.3), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, -0.3 points; 95% CI, -8.1 to 6.9). At 5 years, 41.3% of patients (26/63) in the POEM group and 31.0% of patients (18/58) in the LHM group had endoscopic reflux esophagitis (LA C or D 4.8% in the POEM group, n=3, and 3.4% in the LHM group, n=2). The difference between POEM and LHM was not significant (10.2%, 95% CI: -7.0% to 26.8%, p=0.26). At 5 years, 53.4% (47/88) of patients after POEM vs. 38.8% (33/85) after LHM were administered PPIs (difference 14.6%, 95% CI: -0.3% to 28.8%, p=0.07). In those patients in whom gastroesophageal reflux was measured by pH-metry, pathological reflux was significantly more frequent after POEM (51.1%, 23/45) than after LHM (22.2%, 8/36), difference 28.9% (95% CI: 7.7% to 47.3%), p=0.01. Complications such as peptic stricture or Barrett's esophagus were not reported.

CONCLUSIONS
In this randomized trial, POEM was noninferior to LHM plus Dor’s fundoplication in controlling symptoms of achalasia at 5 years. Gastroesophageal reflux was common in both groups, with a tendency of higher rates among POEM patients in some parameters. (Funded by the European Clinical Research Infrastructure Network and others).