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Penn State Health St. Joseph patient’s gain access to leading clinical trials

Cardiologists leading the way in various trials leading to innovative treatments

Cardiologists at Penn State Health St. Joseph are always looking for better and more effective methods of treating patients who have coronary disease. To that end, St. Joseph is participating in a cutting- edge clinical trial designed to compare the performance of a dissolvable heart stent with that of a non-dissolvable stent currently in use.

Depending on trial outcomes, the dissolvable stent could soon be approved by the U.S. Food and Drug Administration (FDA) for use in the United States. And that, said Dr. Guy N. Piegari, Jr., a cardiologist with Berks Cardiologists, Ltd. and Medical Director of the Cardiac Catheterization Laboratory at Penn State Health St. Joseph, could be significant.

“We’re always moving toward something better,” Piegari said. “The stents that we have are really very good, but we’re always in a continual state of improvement for our patients.”

St. Joseph and Berks Cardiologists have been participating as a team in the randomized control trial, sponsored by Abbot Vascular, a division of Abbott Laboratories, since 2013. The Abbot trial is designed to compare the performance of the company’s new dissolvable stent, Absorb™ Bioresorbable Vascular Scaffold (BVS), with its non-dissolvable stent, XIENCE.

A dissolvable stent could provide significant benefits to patients, Piegari said, because it enables an artery to return to its natural state once it has healed. Currently, some patients whose arteries have narrowed due to buildup of plaque are treated with metal stents containing a medicine that, when released into the artery, prevents the plaque from reforming.

The stent holds the artery open, which enables blood flow. Because it remains in the body, however, it prevents the artery from working as it naturally would. A dissolvable stent is designed to remain in place until the medicine to prevent the rebuild-up of plaque has been dispensed over time, and then gradually disappear. “Arteries are designed to dilate and constrict according to the needs of the body, but they can’t do that well when you’ve got a metal stent in,” Piegari explained. “If the stent dissolves, then there’s nothing left in the artery to interfere with its normal function.”

The clinical trial is required by the FDA before the Absorb stent can be approved in the United States. Absorbable stents are already in use in Europe. The Abbott trial is one of two in which the hospital is currently involved.

St. Joseph and Berks Cardiologists also are involved in a trial sponsored by Swiss-based Biosensors Europe, testing a drug coated, non-absorbable stent known as BioFreedom™. More patients were enrolled in that clinical trial at St. Joe’s than at any other trial site in the country – a significant achievement for the hospital.

“We are the leading contributor in that study,” Piegari said. “If it gets approved, it’s definitely due to our participation.”
These clinical trials involving heart stents are just two of many in which Penn State Health St. Joseph has participated during that past 16 years. “We’ve been conducting clinical research since 1999,” said Lori Shober, Director of Cardiovascular Services. “We’ve been involved in some very cutting-edge research.” Most of the clinical trials have occurred within the Heart Institute and Cancer Center, and have involved hundreds of patients.

Some trials conducted within the Heart Institute have directly contributed to approval by the FDA of devices used in angioplasty and stenting of the carotid, coronary, renal and leg arteries. Participating in clinical trials is time consuming and complex, but the effort that the hospital undertakes is well worth it, Shober said. Trial participation not only increases the profile of St. Joseph, it also helps with advances in the medical field. “It’s just awesome to be involved in research that results in life-saving medical advances,” Shober said. “It’s what we’re about.”

Guy N. Piegari Jr., MD, FACC, FSCAI, is a cardiologist with Berks Cardiologists, Ltd.
He is a Board Certified in Cardiovascular Diseases, Internal Medicine, Interventional Cardiology, and Critical Care Medicine. He can be reached at 610-685-8500.

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