Abbott Initiates ABSORB II Clinical Trial

December 8, 2011—Abbott Vascular (Santa Clara, CA) announced the initiation of the ABSORB II clinical trial of the Absorb bioresorbable vascular scaffold (BVS). ABSORB II is a randomized, controlled, multicenter evaluation of the safety, efficacy, and performance of the Absorb BVS compared to the company's Xience Prime everolimus-eluting coronary stent system. 

According to the company, Approximately 500 patients who have coronary artery disease will be enrolled at 40 investigational sites in Europe and New Zealand. The patients will be randomized at a ratio of 2:1 (Absorb BVS to Xience Prime). The primary endpoints of the trial are change in dimension of the lumen over time and vasomotion at the treated vessel segment, which will be assessed based on changes in vessel diameter in response to a stimulus. Clinical endpoints, including death, myocardial infarction, target lesion revascularization, and scaffold/stent thrombosis, will be assessed at 30 and 180 days and at 1, 2, and 3 years after treatment. Quality-of-life measures will be assessed before treatment, at 180 days, and at 1, 2, and 3 years posttreatment.

The Absorb BVS received CE Mark approval in January 2011 and is authorized for sale in Europe for the treatment of coronary artery disease. In the United States, Absorb is an investigational device and is not available for sale. The Xience Prime received CE Mark approval in 2009 and US Food and Drug Administration approval in 2011, the company advised.

“Absorb has the potential to be an important advancement in the field of interventional cardiology, as clinical trials of this dissolvable device to date suggest that a permanent implant may not be needed to restore and maintain blood flow to the heart,” commented Patrick W. Serruys, MD, Primary Investigator for the ABSORB II clinical trial. “The ABSORB II trial is designed to test unique endpoints to determine the differences between Absorb and a permanent metallic implant, which may provide us with valuable insight into the potential uses of bioresorbable technology in patients with coronary artery disease.”

Abbott noted that it has completed cohort A of the first ABSORB clinical trial, a prospective, nonrandomized, two-stage study in Europe and New Zealand that evaluated the Absorb BVS for treating coronary artery disease. Cohort A was composed of 30 patients. Cohort B is composed of 101 patients. As reported in Cardiac Interventions Today, the ABSORB cohort B 1-year results were presented in April 2011 at the American College of Cardiology's annual scientific sessions. Additionally, Abbott is conducting the ABSORB EXTEND trial, which will enroll approximately 1,000 patients who have complex coronary artery disease at up to 100 centers in Europe, Asia-Pacific, Canada, and Latin America.