Data presented at the EuroPCR congress demonstrated positive six-month results from the first 45 patients enrolled in the second stage of the ABSORB trial.
Patrick W Serruys, Thoraxcentre, Erasmus University Hospital, Rotterdam, The Netherlands, and principal investigator for the trial, told delegates that, at six months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results, with a low (4.4%) rate of major adverse cardiac events (MACE) and no thromboses.
“With each new data milestone, Abbott’s revolutionary BVS technology is one step closer to becoming a reality,” he said. “The device achieved a six-month late loss rate of 0.19mm. 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. These extraordinary findings signal that the disappearing scaffold may become the new standard of care for treating coronary artery disease.”
BVS, which is under clinical investigation in Europe, Australia and New Zealand, and is not currently available for sale anywhere in the world, is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolised and eventually resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a BVS ultimately may have the ability to move, flex and pulsate similar to an untreated vessel.
The ABSORB trial is a prospective, non-randomised (open label), 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 – MACE and treated site thrombosis rates – at 30 days, 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.