Northwestern’s Bluhm Cardiovascular Institute recently enrolled its first subject in ABSORB III, a clinical trial to study a “disappearing” heart device for the treatment of coronary artery disease (CAD). The investigational device, called the Absorb™ Bioresorbable Vascular Scaffold (BVS), made by healthcare company Abbott, is a small mesh tube designed to perform like a metallic stent by opening a blocked coronary artery and restoring blood flow to the heart. Unlike a traditional stent, which remains in the body permanently, the Absorb BVS is a temporary structure that dissolves over time.[i]
ABSORB III is the first U.S. clinical trial to evaluate the Absorb BVS System’s potential benefits in comparison to a traditional drug eluting stent in patients with coronary artery disease (CAD). Researchers at the Bluhm Cardiovascular Institute are the first in Chicago to enroll subjects in the trial.
“Coronary artery disease is the most common heart disease and a leading cause of death in both men and women,” said Mark J. Ricciardi, M.D., medical director for the Northwestern Memorial Hospital’s Center for Coronary Disease at the Bluhm Cardiovascular Institute and Northwestern’s principal investigator for ABSORB III. “For these patients, the supply of blood and oxygen to the heart is blocked by a buildup of plaque in the walls of the coronary arteries. When enough blood doesn’t reach the heart, patients experience symptoms including chest pain and shortness of breath.”
For more than three decades, physicians have treated coronary artery disease with balloon angioplasty and placement of stents. For more severe cases of CAD, coronary artery bypass surgery is sometimes necessary. A stent is a small, mesh coil that is either metal or coated with medications that help the artery remain open; these are known as drug eluting stents. The stent serves to help keep the artery open and decrease the chance of future blockages.
“Since the 1980s, these technologies have allowed many patients to avoid open heart surgery,” said Ricciardi, who is also director of interventional cardiology at Northwestern Memorial and an associate professor at Northwestern University Feinberg School of Medicine. “While we’ve had great success with the current technology, once a stent is placed, it remains in the body forever. However, the stent support is really only needed for several months.”
Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. The device works by opening a clogged vessel and restoring blood flow to the heart similar to a drug eluting metallic stent, the current standard of care. Then unlike a permanent metallic stent, the Absorb BVS dissolves completely into the blood vessel, leaving behind only two pairs of tiny metallic markers which enable a physician to see where the device had been placed.
With this study, researchers are seeking to understand the safety and effectiveness of the Absorb BVS in comparison to a traditional metallic stent. The ABSORB III clinical trial will enroll approximately 2,250 subjects, the majority in the United States.
To learn more about the ABSORB III trial, please call the Bluhm Cardiovascular Institute Clinical Trials Unit (CTU) at 312-926-0840 or email [email protected].
For more information on Northwestern’s Bluhm Cardiovascular Institute, visit www.heart.nmh.org. To schedule an appointment, please call 312-NM-HEART (664-3278).