ABSORB III Trial Studies Bioresorbable Vascular Scaffolding
Worcester, MA — Members of the interventional cardiology team at UMass Memorial Medical Center recently implanted Absorb™, an investigational bioresorbable vascular scaffold (BVS) manufactured by the healthcare company Abbott, as part of the ABSORB III clinical trial. The patients enrolled in the trial were the first in Massachusetts. 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.1
Jeffrey Rade, MD, medical director of the Cardiac Catheterization Lab at UMass Memorial Medical Center, notes that it is exciting to be part of groundbreaking work in the history of treating coronary artery disease. “There have been several landmark treatments for coronary artery disease, from angioplasty to the first stent, and it’s a great opportunity to be at the forefront of the newest treatment option available for patients,” he said.
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), a form of heart 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 build up of fat and cholesterol inside the vessel.
“The Absorb scaffold is different from traditional stents because it has the potential to help repair blockages without leaving behind a permanent metallic stent. This could potentially give the blood vessel the ability to return to a more natural state and reduces the risk for some patients of additional interventions,” said Dr. Rade. “This trial represents an important step in the process of establishing Abbott’s bioresorbable scaffold as a new therapeutic option to treat patients with heart disease, the number one killer of both men and women.”
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
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About UMass Memorial Medical Center
UMass Memorial Medical Center is the advanced tertiary care referral center for Central New England. The Medical Center offers a full complement of sophisticated technology and support services necessary to provide the region with specialists renowned for their work in areas such as cardiology, cancer, diabetes and orthopedics. To learn more about UMass Memorial, please visit www.umassmemorial.org, Facebook, Twitter and YouTube.
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.
AP2938214-US Rev. A. Absorb is a trademark of the Abbott Group of Companies.