New Data Reinforce Strong Long-Term Clinical Performance of Abbott's Absorb™ Bioresorbable Vascular Scaffold
-- Three-year clinical results for treating clogged vessels in the heart with Absorb presented at American College of Cardiology 2013
-- Improvements seen in blood vessel movement and area inside the vessel where the scaffold was placed
SAN FRANCISCO, March 11, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced positive long-term results for the company's innovative Absorb™ Bioresorbable Vascular Scaffold (BVS). Three-year results from 101 patients in the second stage of the ABSORB trial were presented at the 62nd Annual Scientific Session of the American College of Cardiology (ACC) in San Francisco. Absorb is commercially available in Europe as well as other international markets and is an investigational device in the United States.
Absorb is a first-of-its kind device for the treatment of coronary artery disease (CAD), which is a narrowing of one or more blood vessels that supply blood to the heart. Similar to a metallic stent, Absorb works by opening a clogged vessel and restoring blood flow to the heart. Unlike a permanent metallic stent that cages the blood vessel, Absorb dissolves over time, potentially allowing natural vessel function to return.1
Results from the ABSORB trial presented at ACC showed the rate of major adverse cardiovascular events (MACE) in 101 patients was 10 percent at three years, similar to a comparative set of data with a best-in-class drug eluting stent at the same follow-up period. MACE is a combined endpoint that includes heart attack, death due to heart-related causes, or re-blockage of the blood vessel resulting in symptoms requiring the need for additional procedures at the original site of scaffold implantation.
In a subset of 45 patients, state-of-the-art imaging techniques showed improvements in vasomotion (vessel movement) and a 7.2 percent increase in late lumen gain (an increase in the area within the blood vessel) from measurements taken at one and three years. These findings are unique to Absorb and are not typically observed with metallic stents that cage the vessel. There was also a decrease in plaque area inside the vessel between one and three years. Plaque is typically composed of fat, cholesterol, calcium and other deposits that accumulate in the wall of the artery in patients with CAD and can slow or stop blood flow to the heart.
"The three-year data reinforce that Absorb may provide unique benefits not possible with metallic stents, including increases in the average area within the blood vessel, reduction in plaque and improved vessel movement over time," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "As the body of data and real-world experience increase for Absorb, we are seeing compelling evidence that a temporary scaffold that dissolves completely after doing its job represents the future of interventional cardiology treatment." 2
Also, at a recent PCR meeting in Rotterdam, data were presented from the ABSORB EXTEND study, a single-arm trial evaluating Absorb in patients with more complex heart disease than the ABSORB trial. Data from 450 patients enrolled in this trial showed that the rates of MACE at one year were slightly lower than a comparative set of data with a best-in-class drug eluting stent at the same follow-up period. In an analysis of 119 patients with diabetes from the ABSORB EXTEND trial, rates of MACE were comparable between patients with and without diabetes, a promising finding as event rates are typically higher in patients with diabetes when compared to patients without diabetes.
"Abbott's leadership in BVS research and development is unsurpassed, with a robust clinical program for Absorb targeting enrollment of nearly 14,000 patients around the world across a number of ongoing clinical studies. The long-term, three-year results from the ABSORB trial reinforce the strong clinical performance reported previously," said Charles A. Simonton, M.D., divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "Absorb represents the next revolution in interventional cardiology treatment, and Abbott is proud to be at the forefront of BVS clinical research to study Absorb in a wide range of patients with coronary artery disease."
About Coronary Artery Disease
Heart disease is the leading cause of death for men and women around the world, and coronary artery disease (CAD) is the most common type of heart disease.3,4 CAD is a condition in which the arteries that supply blood to the heart become narrowed or blocked by a buildup of plaque, which is composed of fat, cholesterol, calcium and other deposits that accumulate on the inner wall of the artery. Over time, the plaque hardens and narrows the coronary arteries, limiting the flow of oxygen-rich blood to the heart muscle. Areas of plaque can also rupture, causing a blood clot to form on the surface of the plaque. When blood flow to the heart is reduced or blocked, angina (chest pain) or a heart attack can occur.
About the Absorb Bioresorbable Vascular Scaffold
The Absorb Bioresorbable Vascular Scaffold, similar to a small mesh tube, is designed to open a blocked heart vessel and restore blood flow to the heart. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a metallic stent, which is a permanent implant.
Abbott's BVS delivers everolimus, an anti-proliferative drug used in Abbott's XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.
Absorb is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States. Absorb is authorized for sale in CE Mark countries. Absorb is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.
About the Absorb trials
The ABSORB trial is a prospective, single-arm trial that enrolled 131 patients from Europe, Australia and New Zealand in two stages. The first stage started in March 2006 and the second stage in March 2009. Key clinical endpoints of the study include assessments of safety and effectiveness at 30 days, six months and then annually up to five years. The study also will assess the acute performance of the Absorb device (how easily the device can be inserted into the blood vessel). Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive imaging modalities.
ABSORB EXTEND is a prospective, single-arm trial that will enroll approximately 800 patients with more complex coronary disease than previously studied in the ABSORB trial, at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The first patient was enrolled in January 2010. Key clinical endpoints of the study include assessments of safety and effectiveness at 30 days, six months and then annually up to three years. Imaging assessments will also be conducted at varying time points up to two years.
About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
1Preliminary evidence suggests that natural vessel function is possible and may improve long term outcomes. 2Absorb 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. 3The top 10 causes of death, World Health Organization. June 2011 Available at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html 4 Coronary Artery Disease. National Heart, Lung and Blood Institute. May 2011 Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/
CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.
Absorb is a trademark of the Abbott Group of Companies.