Abbott releases ABSORB Bioresorbable Vascular Scaffold study results

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that recruited 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 (MACE) and treated-site thrombosis rates – at 30 days and at six, nine, 12 and 24 months, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the BVS device, including successful deployment of the system.

In an analysis of 56 of the 101 patients, imaging results showed a late loss of 0.27mm, which is comparable to past data on drug eluting stents.

Erasmus University Hospital Thoraxcentre Interventional Cardiology professor Patrick Serruys said the one-year data in these patients confirm earlier results seen at the six- and nine-month periods – that the ABSORB device has the potential to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way not possible with permanent metallic implants.

"In addition, the one-year late loss seen with ABSORB is similar to what has been seen in a historical series of drug eluting stents, which is an encouraging indication that a bioresorbable scaffold like ABSORB might be able to offer the performance capabilities of a metallic drug eluting stent but with the added benefit of eventually dissolving away," Serruys said.