Researchers in the United Kingdom have started enrolling a planned 76 patients for the phase 2, EMBIO randomized controlled trial of left gastric artery embolization for weight loss in patients with severe obesity.
This minimally invasive approach has so far only been tested on just over 100 patients worldwide, so more research is needed, but it has the potential to be a bridge to bariatric surgery in certain patients, say scientists.
The UK investigators are comparing 12-month weight loss with a sham procedure vs left gastric artery embolization — in which a catheter is used to insert microbeads to block the blood supply to the upper stomach where the “hunger hormone” ghrelin, which stimulates appetite, is secreted.
About 15 years ago, researchers had observed that people who underwent this procedure to treat bleeding ulcers in the top of the stomach had greater weight loss than patients who had embolization to other organs or other areas of the stomach, Clifford R. Weiss, MD, one of the clinicians involved, told Medscape Medical News in an interview.
The procedure was first tested for weight loss in animal studies.
Then, in trials involving about 70 patients worldwide, it resulted in a mean weight loss of about 8% at 1 year with acceptable safety, explained Weiss, medical director of the Johns Hopkins Center for Bioengineering, Innovation and Design, and a professor of radiology at the school in Baltimore, Maryland.
His team has published one meta-analysis and one clinical trial of this procedure, and he is collaborating with the researchers at Imperial College London who are performing the EMBIO trial
“Obesity is a major health issue that has a high cost for patients and wider society as it’s associated with a range of health problems such as diabetes, heart disease, and cancer,” lead researcher of the EMBIO study, Ahmed R. Ahmed, MD, PhD, said in a press release from Imperial College London.
Another Tool in the Toolbox?
Although current treatments for obesity include weight-loss drugs, and bariatric surgery, “for some patients these treatments can be ineffective, carry side effects, and be very expensive,” noted Ahmed, a bariatric surgeon at Imperial College.
“There is a real need,” he stressed, “to develop new treatments that are clinically effective, less invasive, more appealing to prospective patients, and cost effective to the [UK] NHS.”
This is especially true for patients “who don’t want to go down a surgical route,” added Prashant Patel, MD, another of the researchers, also from Imperial College London.
Left gastric artery embolization “has been shown to be a promising minimally invasive treatment, but there’s not yet been enough research for us to say how effective it might be,” Patel continued. “Our research will help us to answer this question and see if it could be a viable treatment for people living with obesity.”
There is a large unmet need for ways to obtain weight loss of at least 5%, which has been shown to lower the risk of adverse cardiovascular events, Weiss echoed.
Left gastric artery embolization for weight loss is not meant to replace bariatric surgery, he stressed.
However, one patient reported feeling “unchained from food,” he noted.
This procedure would be “another tool in our toolbox” for treating patients with severe obesity, he added.
Earlier Clinical Trials, Upcoming US Trial
In 2019, Weiss and colleagues published a meta-analysis of six prospective single-arm trials of a total of 47 patients with severe obesity who had left gastric artery embolization for weight loss that was performed at centers in the United States, Belgium, Hungary, and China. The studies were published between January 2014 and April 2019.
In the pooled analysis, the patients lost a mean of 8.1% of their initial weight after a mean 12-month follow-up. Transient superficial mucosal ulcers were common after the procedure, and one patient had severe pancreatitis that was treated by supportive care.
And, as previously reported by Medscape Medical News, the BEAT Obesity trial by Weiss and colleagues that was published online in April 2019 in the journal Radiology found promising 12-month results in 20 patients.
And in June 2020, Vivek Reddy, MD, Mount Sinai Hospital, New York City, presented the 12-month results of the LOSEIT clinical trial at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2020 e-Course, as previously reported.
That trial — performed in a single center in Prague, Czech Republic — randomly assigned 40 patients with severe obesity 1:1 to the embolization procedure or a sham procedure. Patients who underwent the embolization procedure had sustained weight loss at 12 months with no serious adverse effects.
Weiss and colleagues have begun the BEATLES (BAE2) clinical trial, which plans to randomly assign 54 patients with severe obesity 1:1 to receive a sham procedure or the bariatric embolization procedure, with estimated study completion in December 2023.
EMBIO Trial Design
Meanwhile, to be eligible for the EMBIO trial, patients must be 18 to 70 years old with severe obesity (BMI of 35 to 50 kg/m2) and appropriate anatomy for the procedure. Patients who weigh more than 150 kg (330 lb) or have known gastric ulcer or active Helicobacter pylori infection are not eligible.
The patients will be randomly assigned 1:1 to left gastric artery embolization or a sham procedure, along with lifestyle advice.
The primary outcome is weight loss from baseline to 12 months. Secondary outcomes include weight loss at 3 months and 6 months; the percentage of patients who lose at least 5% of their weight; and gut hormone levels, changes in hunger and satiety, and quality of life at 3, 6, and 12 months.
The EMBIO trial is being funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation program .
Content Source: https://www.medscape.com/viewarticle/965280?src=rss