Today, AGH officials announced that the hospital will once again play a prominent role in the study of a novel, first-of-its kind investigational device for CAD that many believe could be the next revolution in the treatment of a disease that strikes more than one million people annually in the United States, claims nearly 500,000 lives each year and is the leading cause of death for both men and women.
Under Dr. Farah’s direction, AGH has been selected to join the ABSORB III clinical trial, a multi-center international study exploring a unique bioresorbable vascular scaffold (BVS), a small mesh tube that is designed to open a blocked artery and then fully dissolve over time, leaving the vessel free of a permanent metallic implant.
The FDA-approved study of the drug-eluting AbsorbTM BVS, made by healthcare company Abbott, is
expected to enroll approximately 2,250 patients over the next 12 months, up to 200 of who could enter the trial at AGH.
“Across every discipline in the treatment of cardiovascular disease, physicians at Allegheny General Hospital continue to set new standards of patient care through pioneering research and clinical ingenuity. The ABSORB study is just the latest example of the innovation that has been a hallmark of our cardiovascular program,” said Dr. Farah, the hospital’s principal investigator in the ABSORB III clinical trial.
Coronary artery disease is a condition in which one or more arteries that supply blood to the heart become narrowed, putting patients at risk of a heart attack and cardiac death. Similar to conventional metallic stents, the Absorb device is designed to open a blocked heart vessel and restore blood flow to the heart.
Unlike metallic stents, however, which are permanently implanted into the blood vessel, Abbott’s Absorb is a uniquely engineered, temporary scaffold that provides support to the vessel until the artery can stay open on its own. Made of polylactide, a naturally dissolvable material that is commonly used in medical implants (such as dissolving sutures), the device dissolves into the blood vessel after its work has been done.
According to Dr. Farah, the potential advantages of a bioresorbable scaffold device are significant when it comes to the long-term management of CAD patients.
“With the standardization of balloon angioplasty and stent implantation and the vast experience that we have accumulated in the use of these techniques, it has become apparent that the most effective and safe means of restoring natural blood vessel function in the setting of coronary disease is ultimately a treatment that leaves nothing behind in the vessel – which was the original idea of angioplasty. The Absorb device moves us in the direction of that goal,” Dr. Farah said.
Balloon angioplasty is a procedure in which a balloon tipped catheter is used to open an area of arterial blockage. The catheter is delivered into the artery through the skin via a small incision in the groin or arm.
Deployed in a similar fashion, stents evolved to help prevent a complication of angioplasty in which the previously opened lesion in the artery gradually re-narrows from continuing plaque build-up – a condition called restenosis. To further improve stent performance, the technology was more recently advanced to include “drug-eluting” devices coated with medications designed to further inhibit the growth of plaque at the treatment site.
For all their effectiveness at improving the outcomes of many patients with CAD, the risks of conventional, permanently placed stents are not insignificant, Dr. Farah said.
Patients receiving stents typically require prolonged use of blood thinning medications to prevent blood clots from forming within the device, which may cause sudden heart attacks. Stented lesions are also still prone to restenosis, particularly among one of the largest subsets of patients at risk for CAD –diabetics.
And for patients with advanced coronary disease, the presence of stents in multiple vessels has the potential to limit future heart surgery options, if needed.
“Because of these concerns, there has always been a desire to find a better way to accomplish the pivotal short term function of stents, without the long-term complications,” Dr. Farah said.
International studies to date of the Absorb device have been extremely encouraging and the start of the ABSORB III U.S. clinical trial follows the recent commercial launch of Absorb in Europe and parts of Latin America, Asia and India.
Absorb III is a prospective, randomized study that will compare Abbott’s drug-eluting Absorb BVS devise to the company’s XIENCETM family of drug eluting metallic stents. Both devices deliver everolimus, an anti-proliferative drug that has been shown to inhibit in-stent plaque growth in coronary vessels.
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.
Dr. Farah said many patients with CAD who are good candidates for stent placement will be eligible for enrollment in the study. Those with questions about the clinical trial can contact Joe Carothers at 412-359-4156.
For more information, contact:
The West Penn Allegheny Health System
The West Penn Allegheny Health System