Abbott's 6-Month ABSORB Data Presented at PCR

May 25, 2010—Abbott Vascular (Santa Clara, CA) announced 6-month results from the first 45 patients enrolled in the second stage of the ABSORB trial of the company's bioresorbable vascular scaffold (BVS). The data were presented at the EuroPCR 2010 conference in Paris. The device is under clinical investigation in Europe, Australia, and New Zealand. It is not currently available for sale anywhere in the world. Abbott's BVS is made of polylactide and delivers everolimus. At 6 months, Abbott's BVS demonstrated a 4.4% rate of major adverse cardiac events and no thromboses.

“The device achieved a 6-month late loss rate of 0.19 mm,” commented Patrick W. Serruys, MD, principal investigator for the ABSORB trial. “This finding suggests that the BVS may have the potential to treat a blocked vessel as effectively as a metallic drug-eluting stent, with the added potential benefit of not leaving a permanent implant behind after the vessel is healed.”

According to the company, 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—major adverse cardiac events and treated- site thrombosis rates—at 30 days and at 6, 9, 12, and 24 months, with additional annual clinical follow-up for up to 5 years. There will also be an assessment of the acute performance of the 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 invasive and noninvasive imaging modalities at 6, 12, 18, and 24 months.

The next 56 patients in the second phase of the ABSORB trial will undergo imaging follow-up 1 year after their procedures, and all 101 patients in the second phase of the trial will receive follow-up imaging at 2 years, the company advised.