New Data Reinforce Strong Long-Term Clinical Performance of Absorb Bioresorbable Vascular Stent
March 15, 2013 — Abbott 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 clinical 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.
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."
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."
For more information: www.abbott.com
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