April 6, 2011 – The second phase of a trial evaluating the world’s first drug-eluting bioresorbable vascular scaffold (BVS) showed positive one-year results. Data from the ABSORB Trial, which looked at Abbott’s BVS, were presented at the American College of Cardiology's (ACC) Scientific Session in New Orleans.
At one year, the device demonstrated a 6.9 percent rate of major adverse cardiac events (MACE) and no reports of blood clots (thromboses). In an analysis of 56 of the 101 patients, imaging results showed a late loss of 0.27 mm, which is comparable to past data on drug eluting stents. Importantly, of the patients' vessels that were assessed for vasomotor function, nearly all showed signs of vasomotion (constriction or dilation of the vessel) at one year. This indicates that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold, which had begun to be metabolized.
"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," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "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."
The device is made of polylactide, a biocompatible material that is commonly used in medical implants such as dissolvable sutures. The device is designed to slowly metabolize and eventually be resorbed by the body after providing support to the vessel during the healing process. It received CE mark in Europe earlier this year and is not approved or available for sale in the United States.
Since a permanent metallic implant is not left behind, a patient's vessel may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes it a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research will show whether the need to administer long-term dual anti-platelet therapy to patients is necessary once the temporary scaffold is metabolized.
"The positive one-year clinical results from the ABSORB trial provide support for the clinical performance of the device and its potential to change the way coronary artery disease is treated," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "Abbott is committed to continuing to build the body of clinical evidence supporting this novel therapy, and we are planning additional clinical trials this year."
For more information: www.abbott.com