St. Francis Clinical Trial Studies "Disappearing" Heart Device
Bon Secours St. Francis Health System recently began enrolling in the ABSORB III clinical trial being conducted in the U.S. ABSORB III is the first U.S. clinical trial to evaluate the potential benefits of the Absorb Bioresorbable Vascular Scaffold (BVS) in comparison to a medicated metallic heart stent, also called a drug eluting stent, in patients with coronary artery disease (CAD), a form of heart disease. Absorb, manufactured by 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.
Christopher Smith, MD, Medical Director of Cardiovascular Services with Bon Secours St. Francis and Interventional Cardiologist with Upstate Cardiology said “If Absorb demonstrates positive results in this trial, this will be a significant advancement in interventional cardiology. It is significant because the metal stents used now stay forever. With Absorb, over time the scaffold is completely gone, which could result in unique benefits not seen before with metallic stents.”
Bon Secours St. Francis is one of the first in the state 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
1Absorb dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.
2 Signs and Symptoms, Centers for Disease Control and Prevention. April 9, 2012. http://www.cdc.gov/heartdisease/signs_symptoms.htm
CAUTION: Investigational device limited by Federal (U.S.) law to investigational use only.
Absorb is a trademark of the Abbott Group of Companies.