Bioresorbable scaffold noninferior to current generation metallic drug-eluting stent
By Liam O'Neil, TCT 2015, San Francisco, USA
Results of the ABSORB III Trial presented at Transcatheter Cardiovascular Therapeutics (TCT) 2015 San Francisco showed that an everolimus-eluting bioresorbable vascular scaffold was non-inferior after one year compared to a current generation metallic drug-eluting stent (DES) for target lesion failure in patients with noncomplex obstructive CAD at 1 year.
The trial randomized 2,008 patients with myocardial ischemia undergoing treatment from 193 clinical sites. Patients were randomized 2:1 to receive an everolimus-eluting BVS (n=1,322) or a cobalt-chromium everolimus-eluting stent (CoCr-EES; n=686). The primary endpoint was target lesion failure (cardiac death, target-vessel myocardial infarction or ischemia-driven target lesion revascularization) at one year.
At 1 year, 7.8% of patients with bioresorbable scaffold experienced target lesion failure vs. 6.1% of patients with cobalt-chromium stent (difference, 1.7 percentage points; 95% CI, –0.5 to 3.9).
Patients treated with BVS and CoCr-EES had non-significantly different rates of cardiac death (0.6% vs. 0.1%, P=0.29), target-vessel myocardial infarction (6.0% vs. 4.6%, P=0.18), and stent thrombosis (1.5% vs. 0.7%, P=0.13). Alos, no statistically significant differences between BVS and CoCr-EES in the one-year rates of ischemia-driven target lesion revascularization (3.0% vs. 2.5%, P=0.50), angina (18.3% vs. 18.4%, P=0.93) or ischemia-driven TVR (5.0% vs. 3.7%, P=0.21).
Lead investigator Dean J. Kereiakes, MD, Medical Director of The Christ Hospital Heart and Vascular Center and the Lindner Research Center at The Christ Hospital in Cincinnati, Ohio said:“Bioresorbable vascular scaffolds are the newest generation of stent technology aimed at improving long-term outcomes in patients.
“Results from the ABSORB III trial showed that treatment of non-complex obstructive coronary artery disease with BVS was non-inferior to the best in class CoCr-EES for target lesion failure at one year. Long-term follow-up data from this and other large-scale trials are required to determine whether these findings translate into improved longer-term clinical outcomes beyond one year.”
Gregg W. Stone MD, study chairman of the ABSORB III trial added: “This device may be an attractive alternative for young patients, for those with acute coronary syndromes in whom metallic stents heal poorly, and for patients and physicians wishing to avoid a permanent implant. The real potential advantages, however, are expected to emerge over time as the device dissolves, restoring the normal functioning of the coronary artery.”
Data from the ABSORB III trial will be reviewed by the FDA as it considers whether or not to approve this device.