Baptist Medical Center South recently enrolled a patient into the ABSORB III clinical trial. This trial involves the implantation of Absorb ™, an investigational bioresorbable vascular scaffold (BVS), as part of the ABSORB III clinical trial started earlier this year in the United States. Manufactured by the healthcare company Abbott, 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. 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. Baptist South is the first in Central Alabama to enroll patients in the ABSORB III trial.
According to cardiologist and the principal investigator for the trial in Montgomery, Narinder Bhalla, M.D, this platform may change how we treat our patients with coronary artery disease. “Currently the stents we use are made of metal alloys, and once in the blood vessel stay there for life, and cannot be removed. The new scaffolding system is bioresorbable, meaning that it dissolves over time and leaves nothing behind in the blood vessel after except for two pair of tiny markers to see where the scaffold was originally placed. Hence it has the potential to allow the blood vessel to regain vessel motion once the scaffold has dissolved.”
CAD is a leading cause of death for men and women in the United States. 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.
The ABSORB III clinical trial will enroll approximately 2,250 patients 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.
“Participation in this trial is very exciting for our community,” Dr. Bhalla said. “We are honored to be one of the few centers in Alabama and in the country to be involved in the trial. This new technology will allow us to offer cutting edge technology to our patients in its earliest stages of use. Our patients qualifying for this device will be receiving this technology about two years ahead of the general population. This study is extremely competitive, and for Baptist South to have gotten in is a major feather in our cap and our patients will derive great benefits.”
According to the Centers for Disease Control and Prevention, about 785,000 Americans have a first heart attack each year. 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.
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Montgomery's Baptist South a part of FDA approval trial for a bio-resorbable stent