The Lancet Publishes Results From World's First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent

Friday, March 14, 2008 General News
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ABBOTT PARK, Ill., March 13 Data published todayin The Lancet from ABSORB, the world's first clinical trial of a fullybioabsorbable drug eluting stent for the treatment of coronary artery disease,demonstrated no stent thrombosis, no clinically driven target lesionrevascularizations (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 stentwere consistent with performance demonstrated by the system at 6 months, aspreviously reported in October 2007('s prospective, non-randomized, ABSORB clinical trial is designed toevaluate the overall safety and performance of a fully bioabsorbableeverolimus eluting stent out to 5 years.

"Abbott's bioabsorbable everolimus eluting stent has demonstratedexcellent clinical safety out to one year in patients with coronary arterydisease," said Patrick W. Serruys, M.D., Ph.D., Professor of InterventionalCardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, andco-principal investigator in the ABSORB study. "The positive results from thisclinical trial form a strong basis for the development of additionalbioabsorbable stent platforms with the potential to eliminate some of therestrictions posed by metallic stents in areas such as vessel imaging andvessel 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 lumendiameter after stenting, was 0.44 mm. At one year, the overall MACE rate inthe 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 fromfollow-up, known to be event free at 1 year, n=29). MACE is a compositemeasure 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 percentprocedural success and 94 percent device success in the ABSORB trial.

"Patients and physicians like the idea of a stent that does its job and isthen absorbed away," said John A. Ormiston, M.B., Ch.B., cardiologist atAuckland City Hospital, in Auckland, New Zealand and principal investigator inthe ABSORB trial. "Abbott's bioabsorbable stent has the potential to hold anartery open long enough for healing to occur, and we would expect an arterythat is healed to function as it did before it became diseased."

Abbott is the only company with a fully bioabsorbable drug elutingcoronary stent in clinical trials. Abbott's bioabsorbable everolimus elutingcoronary stent is made of polylactic acid, a proven biocompatible materialthat is commonly used in medical implants such as dissolvable sutures. As witha metallic stent, Abbott's bioabsorbable stent is designed to restore bloodflow in clogged coronary arteries, and to provide mechanical support until theblood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent isdesigned to be slowly metabolized by the body and completely absorbed overtime.

"Abbott's bioabsorbable drug eluting stent system is a great example ofscientific innovation leading to a breakthrough treatment for heart diseasethat has potential to improve patients' lives," said John M. Capek, Ph.D.,executive vice president of medical devices at Abbott. "We look forward tocontinuing to evaluate the safety and effectiveness of our bioabsorbable stentplatform in additional patients in the coming months."

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label) studydesigned to enroll up to 60 patients in Belgium, Denmark, France, New Zealand,Poland and The Netherlands. Key endpoints o

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