Orion Kristine

Ohio State first in U.S. to randomize patient in novel aortic aneurysm trial

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Plant compound shows promise in slowing growth of smaller aneurysms

Orion Kristine

COLUMBUS, Ohio – The Ohio State University Wexner Medical Center is the first in the United States to randomize a patient in a clinical trial looking at whether a plant compound derived from mangoes is effective in slowing the growth of small and medium size abdominal aortic aneurysms.

An aortic aneurysm is a weakened or bulging area on the wall of the aorta, which carries blood from the heart to the body. Aortic aneurysms most often occur in the abdomen but can also occur in the upper chest (thoracic aortic aneurysm). Aneurysms that burst or dissect (a tear in the inner layer of the aorta) can cause severe internal bleeding, which can be fatal. About 10,000 Americans die from aortic aneurysm-related deaths each year, according to the Centers for Disease Control.

Physicians use an ultrasound or CAT scan to monitor patients who have smaller abdominal aortic aneurysms to see how much they are growing and how quickly. Surgery is recommended for women whose aneurysms are larger than 5 centimeters or 5.5 centimeters in men. Patients can live with aortic aneurysms for decades without needing intervention.

“Some patients are really worried about living with an aneurysm because of their family history or they have a friend who suffered aortic rupture. Some describe it as a ticking time bomb and can become mentally incapacitated. The potential benefits of this novel approach are enormous for these patients, and it has minimal risk,” said Kristine Orion, MD, site principal investigator of the trial, vascular surgeon at the Ohio State University Wexner Medical Center and director of the Ohio State Aortic Center. She works closely with Subhashish Das who is the trial’s coordinator at Ohio State.

Abdominal aortic aneurysms are caused by a breakdown of elastin in the aortic wall. In the clinical trial, surgeons deliver pentagalloyl glucose (PGG), a natural plant compound, to directly treat the aortic vessel wall using a balloon catheter. PGG has been found to bind to the elastin and collagen, strengthening the wall and slowing the growth of aneurysms, which can lead to rupture. The outpatient procedure takes about an hour and is minimally invasive.

The FDA has granted the Nectero EAST system both breakthrough and fast-track therapy designations. The average growth rate of an aneurysm is 2 to 3 millimeters per year. In an earlier feasibility trial, patients treated with PGG had significantly slower aneurysm growth, in particular for those with smaller aneurysms.

“Results from the early phase of the trial are really exciting. It’s possible that this treatment will mean patients won’t ever reach the threshold for needing surgery,” said Orion, who is also a clinical professor of surgery at The Ohio State University College of Medicine and holds the Philip Barbour Hardymon Professorship in Surgery.

The Nectero EAST trial is one of five aortic clinical trials currently being conducted at the Aortic Center. The Ohio State University is in the Top 10 nationwide for clinical trials.