Winchester Medical Center conducts innovative study

By Kim Walter

Winchester Medical Center has initiated a clinical trial to test a new treatment of heart disease.

Doctors in Winchester are the first in Virginia to implant Absorb, an investigational bioresorbable vascular scaffold, as part of the nationwide ABSORB III clinical trial started earlier this year by the health care company Abbott.

The device is the fourth generation of advancements in the treatment of heart disease, according to Neal Gaither, interventional cardiologist and principal investigator for the trial.

Before the late 1970s, open heart surgery was the only option for treating patients with persistent symptoms of coronary heart disease, but since 1977, less invasive devices have come about.

In 1988, a bare metal stent was developed. The metallic mesh tube would be implanted into a blocked vessel in the heart to restore blood flow and keep the vessel open over time. From there came the drug-eluting stent, which was coated with medication to prevent re-narrowing of the blood vessel where the stent was placed.

The new Absorb scaffold is a drug-eluting mesh implant made of polylactide, a material used in dissolving sutures. The device not only restores blood flow to the heart, but dissolves after doing its job, which could allow natural vessel function to resume.

Absorb also could prevent blockage occurring on and around the stent itself, which sometimes happens with metal stents and can lead to more complications.

Currently, 43 “centers of excellence” across the United States are participating in the trial, but Winchester Medical Center is the only participant in Virginia.

Jennifer Stanford, Valley Health’s director of clinical research, said the medical center has screened 41 patients to possibly be implanted with the scaffold. Of those 41, four patients have met the strict criteria.

However, the trial is a single blind study, which means that only the cardiologists conducting the procedure know which patient was actually implanted with Absorb, as opposed to the traditional metallic stent.

The first procedure took place on April 22, and others have followed.

Gaither said the Absorb stent would release medication to the diseased area of a vessel. After a vessel has been open for about a year and normal blood flow is restored, the scaffold would dissolve over the next couple of years.
However, patients who are a part of the study now won’t know what kind of stent they were implanted with until the five year study is complete.

In order to be able to perform the procedure, interventional cardiologists, including Gaither, had to undergo eight hours of training. He said it was exciting to be a part of something new that could change the way things are done in treating heart disease.

“This is a big deal,” he said. “We’re getting to do and learn about things that other hospitals won’t even experience for another seven to nine years.”

Criteria for patients wanting to participate in the study included having persistent and even severe symptoms, but not having a heart attack. If the product gets approved by the FDA and becomes available to all medical facilities, then the criteria would lessen, Stanford said.

Robert Lyons, 79, of Keyser, W.Va., is one of the four patients who fit the criteria. He was brought to the hospital in mid-April after having severe chest pain that would come and go with daily activities.

Even though he didn’t have a heart attack, he and his doctor felt he was headed in that direction.

“The pressure and pain that I was feeling put me on the floor,” Lyons said Tuesday.

He was told about the clinical trial, and after consulting with his wife, decided to give it a try.

Lyons had the surgery on April 26, and claims he’s felt 100 percent better ever since. Of course, he still doesn’t know if that’s thanks to Absorb or a normal drug-eluting stent.

“It’s kind of neat to think that I might be one of the first people in the country to get that,” he said. “But I’m really just happy that I feel better.”

Abbott plans to enroll about 2,250 patients in the trial by the end of 2013, after which the real data and results will slowly become available. Stanford said the fact that Winchester Medical Center was chosen among a number of university hospitals in the state says a lot about the facility’s ability to conduct studies and produce meaningful data.

“It just goes along with our goal to give the highest quality of care possible,” she said. “Through our research we become very detail oriented, and that often means a better outcome for patients.”

Contact staff writer Kim Walter at 540-465-5137 ext. 191, or kwalter@nvdaily.com