Bay Medical Sacred Heart Initiates Clinical Trial to Test Bioresorbable Vascular Scaffold for Treatment of Heart Disease
March 20, 2014
Christa Dean Hild
Panama City, FL — Interventional cardiologist Dr. Amir Haghighat recently enrolled the first local patient in an investigational trial of Absorb™, a bioresorbable vascular scaffold (BVS), at Bay Medical Sacred Heart. Absorb, manufactured by the healthcare company Abbott, 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. The trial, called ABSORB III, is the first U.S. clinical trial to evaluate the potential benefits of Absorb in comparison to a medicated metallic heart stent, also called a drug eluting stent, in patients with coronary artery disease (CAD). Bay Medical Sacred Heart is the first in the region to enroll patients in the ABSORB III trial.
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 build up of fat and cholesterol inside the vessel.
Since the 1970s, physicians have treated patients with CAD with balloon angioplasty, metallic and drug eluting metallic stents, allowing many patients to avoid open heart surgery. About a decade ago, scientists at Abbott started development of Absorb and now Abbott is the first company in the world to begin testing a bioresorbable vascular scaffold in patients in the United States.
Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. Abbott's Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
The ABSORB III clinical trial will enroll approximately 2,250 patients, the majority in the United States. The primary endpoint of the 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.
Each year, about 785,000 Americans have a first heart attack. Another 470,000 who have already experienced one or more heart attacks will have another. Heart disease accounts for one of every six deaths that take place in the U.S.2
For more information about the trial or heart services at Bay Medical, please contact Christa Davis at (850)747-6542 or visit our website at www.baymedical.org.