At 3 years, radiofrequency ablation for dysplastic Barrett’s esophagus resulted in complete eradication of dysplasia in 98% of patients, Dr. Nicholas J. Shaheen and colleagues reported in the August issue of Gastroenterology.
The finding represents the latest results from the Ablation of Intestinal Metaplasia Containing Dysplasia Study (AIM Dysplasia Study). The study’s 12-month results were published by Dr. Shaheen and colleagues in 2009 (N. Engl. J. Med. 2009;360:2277-88).
Dr. Nicholas J. Shaheen
According to Dr. Shaheen, director of the center for esophageal diseases and swallowing at the University of North Carolina, Chapel Hill, the original study recruited 127 patients aged 18-80 years with nonnodular Barrett’s esophagus less than or equal to 8 cm in length.
Patients were randomized in a 2:1 ratio to either radiofrequency ablation (n = 84) or endoscopic surveillance – simple endoscopy with no treatment, the sham arm (n = 43). In the current follow-up, Dr. Shaheen and his colleagues reported on the durability of the treatment at 2 and 3 years post ablation Gastroenterology 2011 August [doi:10.1053/j.gastro.2011.04.061]).
"After completion of the 12-month assessment, subjects in the sham arm were offered crossover to active (RFA) treatment," wrote the investigators. All 35 of the original 43 sham subjects who were eligible for crossover elected to receive treatment (4 had developed esophageal adenocarcinoma while in the sham arm prior to the 1 year end point, and 4 were lost to follow-up). All treated subjects were then followed for 2 years after receiving RFA therapy.
Overall, 119 subjects underwent ablation (84 at study outset plus 35 crossovers), with 106 completing at least the 2-year follow-up. At 2 years, 101 of 106 (95%) of subjects had complete eradication of dysplasia, and 99 of 106 (93%) had complete eradication of intestinal metaplasia, the authors reported. However, over the mean follow-up period of 3.05 years, 25 subjects required an interim focal treatment of recurrent Barrett’s. Moreover, "in the most stringent analysis, if we include any subject who ever received any RFA and left the trial before the 2 year end point as a failure (n = 13), the response rates were 101/119 (85%)" for complete eradication of dysplasia and 99 of 119 (83%) for complete eradication of intestinal metaplasia, the authors added.
Among the 56 subjects for whom 3-year follow-up data were available, 55 (98%) had complete eradication of dysplasia and 51 (91%) had complete eradication of intestinal metaplasia. The annual rate of any neoplastic progression was 1.37% per patient-year, or 1/73 patient-years.
Four serious adverse events have occurred to date in the 119 subjects (3.4%): one upper gastrointestinal bleed in a patient on dual aspirin and clopidogrel therapy for heart disease; one episode of chest pain occurring 8 days following ablation; and two overnight hospitalizations for nausea and chest pain immediately following the procedure.
"The main adverse side effect was stricture occurrence, which occurred in 7.6% of subjects and was correctable with a mean of 2.8 dilation sessions," the investigators wrote. There were no perforations or procedure-related deaths.
Radiofrequency ablation in this study was accomplished with a device made by BÂRRX Medical, which supported both the 2009 study and the current follow-up. Several investigators also reported financial relationships with BÂRRX Medical, among other pharmaceutical makers. AstraZeneca supplied esomeprazole for the patients through the company’s investigator-sponsored study program.