Abbott Presents 3-Year ABSORB Data at AHA Meeting

November 16, 2009—Abbott Vascular (Santa Clara, CA) announced 3-year data from the first 30 patients in the first phase of the ABSORB clinical trial. The data demonstrate that the company's fully bioabsorbable everolimus-eluting coronary stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries. The company reported that patients experienced no stent thrombosis out to 3 years and no new major adverse cardiac events between 6 months and 3 years (3.6% at 3 years). These results were presented at the 2009 American Heart Association's Scientific Sessions in Orlando, Florida.

Abbott Vascular also stated that it is initiating ABSORB EXTEND, a large-scale trial that will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada, and Latin America. ABSORB EXTEND is a single-arm study designed to further evaluate the performance of Abbott's fully bioabsorbable stent technology. The study will enroll patients with more complex coronary artery disease and is slated to begin enrolling before the end of the year.

The company also announced that patient enrollment is complete for the second phase of the ABSORB trial. The second phase enrolled 101 additional patients from 12 centers in Europe, Australia, and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support.

According to Abbott Vascular, the ABSORB trial is a prospective, nonrandomized, two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland, and Switzerland. Key endpoints of the study include assessments of safety—major adverse cardiac events and stent thrombosis rates—at 30 days; 6, 9, 12, and 18 months; and 2 years, with additional annual clinical follow-up for up to 5 years, as well as an assessment of the acute performance of the device, 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 months, 1 year, and 2 years. Patrick W. Serruys, MD, is the principal investigator for the ABSORB trial.