Vanderbilt Heart and Vascular Institute is participating in a clinical trial to evaluate a medical device for the treatment of coronary artery disease.
The randomized, controlled trial, sponsored by Abbott, compares the Absorb Bioresorbable Vascular Scaffold (BVS) to a medicated metallic heart stent, which is the current standard of care.
Vanderbilt Heart is one of the first hospitals in Middle Tennessee to enroll patients in the ABSORB III trial, which will eventually include about 2,250 patients, the majority in the United States.
Absorb is a small mesh tube that is designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the blood vessel over time.
Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold because it is a temporary structure.
Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
“Stents are great but anything can be improved upon,” said Joseph Fredi, M.D., assistant professor of Medicine and an interventional cardiologist.
“When drug eluting stents came out, we didn’t think there’d be another way to improve upon them. But, the bioresorbable scaffold is the next development in being able to open a clogged artery and restore blood flow without leaving any foreign material behind except two tiny metallic markers to show us where the scaffold was originally placed,” Fredi said.
Coronary artery disease (CAD) is a leading cause of death for men and women in the United States, and patients with CAD can experience symptoms such as chest pain and shortness of breath when the demand for blood to the heart is more than the heart’s ability to supply blood due to blockages in the vessels that supply blood to the heart.
These blockages are caused by the buildup of fat and cholesterol inside the vessel. Drug eluting stents and the Absorb BVS slowly discharge medication that prevents the formation of scar tissue, which can block an artery.
The primary endpoint of the ABSORB III trial is target lesion failure, a combined measure of safety and efficacy, at one year.
In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.
John McPherson, M.D., associate professor of Medicine and vice-chair for Education, is the principal investigator at Vanderbilt Heart.
Laura Maynard, R.N., Sean Johnson, R.N., and Lynn Blair-Anton, R.N., are the research coordinators.
