Abbott Vascular Presents ABSORB Trial Data

September 22, 2010—Abbott Vascular (Santa Clara, CA) announced that the results from the first 45 patients enrolled in the second stage of the ABSORB trial were presented by coprincipal investigator John Ormiston, MD, presented at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The company stated that its bioresorbable vascular scaffold (BVS) demonstrated strong results at 9 months that remained consistent with the 6-month data from the same 45-patient group. The rate of major adverse cardiac events (MACE) was unchanged at 4.4% and there were no reports of thromboses. Abbott's polylactide, everolimus-eluting BVS is under investigation in two clinical studies, ABSORB and ABSORB EXTEND, and is currently not available for sale anywhere in the world.

According to Abbott Vascular, the ABSORB trial is a prospective, nonrandomized, two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland, and Switzerland. Key endpoints of the study include assessments of safety—MACE and treated-site thrombosis rates—at 30 days, 6, 9, 12, and 24 months, with additional annual clinical follow-up for up to 5 years, as well as an assessment of the acute performance of BVS, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound, optical coherence tomography, and other state-of-the-art invasive and noninvasive imaging modalities at 6, 12, 18, 24, and 36 months.
 


The ABSORB EXTEND trial is a single-arm study that is currently enrolling patients at up to 100 centers in Europe, Asia Pacific, Canada, and Latin America. The trial will enroll approximately 1,000 patients, including patients with more complex coronary artery disease, the company stated.

“I am impressed with how consistent the BVS data have been to date, as the 9-month data are compelling and supportive of earlier positive results,” commented Dr. Ormiston. "In addition to the positive safety data we've seen to date, the late loss rate of 0.19 mm reported at 6 months is comparable to a metallic drug-eluting stent and may address a limitation of metal stents by not leaving metal in the artery. This technology is truly a step forward for the field of interventional cardiology, and I am excited about the prospect of treating patients with this revolutionary product.”
 


Abbott also presented 6-month results for all 101 patients enrolled in the second stage of the ABSORB trial. In this complete patient population, the MACE rate remained consistent, with an increase from 4.4% at 6 months in the first 45 patients to 5% at 6 months in all 101 patients. There were no reports of thrombosis in any of the 101 patients.
 


"We are pleased with the progress of ABSORB and the encouraging data we continue to see from the trial in the entire cohort of more than 100 patients," commented Patrick W. Serruys, MD, coprincipal investigator for the ABSORB trial. "The findings to date show that the device appears to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way that is not possible with permanent implants."