A newly-published peer-reviewed clinical study evaluated 217 patients pre-treatment and tracked them for ten years after receiving Stretta Therapy to treat gastroesophageal reflux disease (GERD). The study, entitled “Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later,” is published in the online February edition of Surgical Endoscopy and highlights the long-term treatment outcomes of refractory GERD patients who received Stretta Therapy. In this study, the authors recognize the unmet need for treatment options in these 40 percent of GERD patients who do not adequately respond to medications, and assess the Stretta option for this underserved patient population. The study successfully reached all primary and secondary outcomes, with significant improvements in, GERD-health-related quality of life (HRQL) scores, patient satisfaction, and PPI use with results being durable at 10 years in the majority of patients. Additionally the study found a regression in Barrett’s metaplasia, and no adverse effects of treatment, confirming the procedure’s long-term safety.
The long-term maintenance effects of Stretta seen in this study include:
- Normalization of GERD HRQL scores was achieved in 72 percent of patients (primary endpoint 70 percent)
- A 50 percent or greater reduction in PPI use occurred in 64 percent of patients – 41 percent eliminated PPIs entirely
- The majority of patients remained satisfied with their Stretta results at 10 years
- Pre-existing Barrett’s metaplasia regressed in 85 percent of biopsied patients, and no cases of esophageal cancer occurred
“This 10 year follow-up study confirms the findings of safety, efficacy and durability of Stretta that have been demonstrated in a multitude of other published studies since 2001,” the study lead author, Mark Noar, MD, MPH of Endoscopic Microsurgery Associates PA, Heartburn & Reflux Study Center, stated. He noted that to date, there are 33 human subject clinical peer-reviewed published studies of Stretta, by 28 different study investigators, reporting on 2,400 patients which includes four randomized, controlled trials and three other longer term four year studies. “The outcomes of these studies, which were performed in various academic and community based facilities around the world, show a remarkable consistency of symptom improvements and reduction in acid exposure after Stretta,” he said.
A review of this large body of clinical data earned Stretta the strongest grade recommendation in a Clinical Spotlight Review guideline from The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in 2013.
Stretta studies have also shown the mechanism of action behind RF energy delivery as a reduction in transient relaxations of the lower esophageal sphincter muscle (LES), reduced tissue compliance without fibrosis, and a thickening of the sphincter muscle, improving barrier function and improving symptoms.
“What is so significant about this 10-year study is that it shows that Stretta meets the need for long-term and safe control of the underlying cause of reflux – without surgery,” observed Dr. Noar. “Looking at this data in the context of other GERD treatments, patient satisfaction with Stretta is higher than with either long-term PPI use or anti-reflux surgery. Given concerns about long-term PPI use, the long-term durability of Stretta as seen in this study suggests this therapy as a way to correct reflux, reduce medication, and improve quality of life for these patients.”
The Barrett’s Esophagus Subset
In this study, patients with short segment Barrett’s were included and in those available at 10 years for follow-up, 28 of 33 patients had no further dysplasia and/or metaplasia, and the remaining five had no progression of the disease. “This is the first study of its kind that has followed this type of patient for 10 years. The data clearly suggests that Stretta may provide a protective effect for the Barrett’s tissue that could allow healing to occur,” commented Dr. Noar. “Additionally because of the non-incidence of esophageal cancer at 10 years in these Barrett’s patients, it raises the question of whether the reduction of reflux episodes as a result of Stretta helps limit the development of this growing condition in those with reflux.”
For the published online study go to: http://link.springer.com/article/10.1007%2Fs00464-014-3461-6