The Lancet Publishes Results From World's First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary StentFuture Generation Treatment from Abbott Shows No Thrombosis, Low MACE Rates Out to One Year in Preliminary Clinical Study of Thirty Patients
ABBOTT PARK, Ill., March 13, 2008 /PRNewswire-FirstCall/ -- Data published today in The Lancet from ABSORB, the world's first clinical trial of a fully bioabsorbable drug eluting stent for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations (retreatment of a diseased lesion), and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year. These one year results for Abbott's bioabsorbable everolimus eluting stent were consistent with performance demonstrated by the system at 6 months, as previously reported in October 2007 (www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0529.htm). Abbott's prospective, non-randomized, ABSORB clinical trial is designed to evaluate the overall safety and performance of a fully bioabsorbable everolimus eluting stent out to 5 years.
"Abbott's bioabsorbable everolimus eluting stent has demonstrated excellent clinical safety out to one year in patients with coronary artery disease," said Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, and co-principal investigator in the ABSORB study. "The positive results from this clinical trial form a strong basis for the development of additional bioabsorbable stent platforms with the potential to eliminate some of the restrictions posed by metallic stents in areas such as vessel imaging and vessel remodeling."
At 6 months, the overall MACE rate in the ABSORB trial was 3.3 percent (one patient, n=30) and late loss, a measure of reduction in vessel lumen diameter after stenting, was 0.44 mm. At one year, the overall MACE rate in the ABSORB trial was consistent with results at 6 months (one patient, 3.3 percent, n=30; 3.4 percent adjusted for one patient who withdrew from follow-up, known to be event free at 1 year, n=29). MACE is a composite measure of cardiac death, heart attack and re-treatment of a diseased lesion (ischemia-driven target lesion revascularization) in the ABSORB trial. Abbott's bioabsorbable everolimus eluting stent also demonstrated 100 percent procedural success and 94 percent device success in the ABSORB trial.
"Patients and physicians like the idea of a stent that does its job and is then absorbed away," said John A. Ormiston, M.B., Ch.B., cardiologist at Auckland City Hospital, in Auckland, New Zealand and principal investigator in the ABSORB trial. "Abbott's bioabsorbable stent has the potential to hold an artery open long enough for healing to occur, and we would expect an artery that is healed to function as it did before it became diseased."
Abbott is the only company with a fully bioabsorbable drug eluting coronary stent in clinical trials. Abbott's bioabsorbable everolimus eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott's bioabsorbable stent is designed to restore blood flow in clogged coronary arteries, and to provide mechanical support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.
"Abbott's bioabsorbable drug eluting stent system is a great example of scientific innovation leading to a breakthrough treatment for heart disease that has potential to improve patients' lives," said John M. Capek, Ph.D., executive vice president of medical devices at Abbott. "We look forward to continuing to evaluate the safety and effectiveness of our bioabsorbable stent platform in additional patients in the coming months."
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands. Key endpoints of the study include assessments of safety -- MACE (defined as any event that resulted in re-treatment of a diseased artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates -- at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.
For images of Abbott's bioabsorbable stent and other information, please visit the company's online newsroom at http://www.abbottvascular.com/presskit.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 68,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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Posted: March 2008