ABSORB

April 3, 2011—Abbott Vascular (Santa Clara, CA) announced 1-year results from 101 patients enrolled in the second phase (Cohort B) of the ABSORB trial evaluating the company's everolimus-eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease.

According to Abbott Vascular, the ABSORB trial is a prospective, nonrandomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland, and Switzerland. Cohort A was composed of 30 patients. Cohort B was composed of 101 patients.

At 1 year, Abbott's Absorb device demonstrated a low 6.9% rate of major adverse cardiac events (MACE) and no reports of thromboses. In an analysis of 56 of the 101 patients in Cohort B, imaging results showed a late loss of 0.27 mm, which is comparable to past data on drug-eluting stents, the company stated.

Abbott Vascular noted that nearly all patients' vessels assessed for vasomotor function showed signs of vasomotion at 1 year, indicating that the vessels were no longer constrained by the scaffold, which had begun to be metabolized.

Key endpoints of the study include assessments of safety— MACE and treated-site thrombosis rates—at 30 days and at 6, 9, 12, and 24 months. Additional endpoints include annual clinical follow-up for up to 5 years, as well as an assessment of the acute performance of the BVS 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, 12, 18, and 24 months.

Results from the first stage (Cohort A) of the ABSORB trial with 30 patients demonstrated that Abbott's BVS successfully treated coronary artery disease and was resorbed into the walls of treated arteries after approximately 2 years. Patients in this first stage of the ABSORB trial experienced no thromboses out to 4 years and no new MACE between 6 months and 4 years (3.4% at 4 years).

The Absorb device received CE Mark in Europe earlier this year. It is not approved or available for sale in the United States, the company advised.