Abbott has presented three-year study data from a prospective, single-arm clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device for the treatment of patients with coronary artery disease.
Featuring a multi-link stent design, the Absorb BVS device delivers an anti-proliferative everolimus drug for inhibiting in-stent neointimal growth in the coronary vessels following stent implantation.
The device, similar to a metallic stent, opens a clogged vessel, restores blood flow to the heart and dissolves polylactide material to allow natural vessel function to return.
The trial, ABSORB, has enrolled 131 patients from Europe, Australia and New Zealand to assess the acute performance of the Absorb device.
The trial’s other key endpoints include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT) and other invasive imaging modalities.
The study demonstrated that in 101 patients, the rate of major adverse cardiovascular events (MACE) was 10%, while 45 patients showed improvements in vasomotion.
The study, which reported a 7.2% increase in late lumen gain (an increase in the area within the blood vessel) from measurements taken at one and three years, also showed a decrease in plaque area inside the vessel between one and three years.
Erasmus University Hospital Thoraxcentre interventional cardiology professor Dr Patrick Serruys said; "As the body of data and real-world experience increase for Absorb, we are seeing compelling evidence that a temporary scaffold that dissolves completely after doing its job represents the future of interventional cardiology treatment."
Abbott Vascular chief medical officer and medical affairs divisional vice president Dr Charles Simonton said; "Absorb represents the next revolution in interventional cardiology treatment, and Abbott is proud to be at the forefront of BVS clinical research to study Absorb in a wide range of patients with coronary artery disease."
The company said the BVS device, which is commercially available in Europe as well as other international markets, is an investigational device in the US.