The Absorb bioabsorbable stent made by Abbott (NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.
One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.
The trial showed a rate of target lesion failure of 7.8% for the Absorb arm and 6.1% for the Xience arm and no significant difference in rates of cardiac death (0.6% for the Absorb stent and 0.1% for the Xience stent); target vessel myocardial infarction (6.0% and 4.6%, respectively); or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively. Device thrombosis occurred in 1.5% of Absorb patients and 0.7% of Xience patients, according to the study, which was also published in the New England Journal of Medicine.
“The Absorb III data shows that there are no statistically significant 1-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care,” co-principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center said in prepared remarks. “Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention, and Absorb is leading the way as an innovative option. Absorb does its job and then restores the vessel to its natural state over time, which cannot be achieved with a permanent drug eluting stent.”
During a press conference discussing the results, Kereiakes cited Absorb’s performance in the context of a 1st-generation device going up against what he called the “gold standard” in Xience.
“The remarkable thing is that a gen-1 device really goes toe to toe [with Xience],” he said. “Longer-term evaluation is ongoing to determine if Absorb improves late outcomes compared with Xience.”
Asked about the value proposition for Absorb versus Xience, Dr. Daniel Simon of Cleveland’s Harrington Heart & Vascular Institute said providers are usually willing to pay a little more for new technologies.
“In medicine, in general, when you have technological iterations and innovations, one tends to pay more,” Simon said. “Health systems allow for companies to make fair profit, [in order] to have advances in medicine. … The long and the short of it is, we’ll pay a little more for a device that patients are asking for.”
Data from 2 other studies presented today at TCT 2015, Absorb II and Absorb China, also showed that the Absorb device functions similarly to Xience.
“The trial met all its major endpoints, and given all the attributes my opinion is that it should be approvable,” said Dr. Gregg Stone of New York’s Columbia University Medical Center, global chairman of the study. “We’ve got good reason to be very hopeful that the long-term outcomes for patients will be improved with this device compared with a normal metallic drug-eluting stent.
“A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition,” Stone said. “It will be very good for young patients who will live 30 or 40 years with this decision.”
“Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent. However, because Absorb leaves nothing behind it may provide significant longterm benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb,” added Abbott vice president Dr. Charles Simonton in a press release. “At Abbott we will continue to study Absorb in our robust clinical trials to show the long-term benefits of Absorb that differentiate it from permanent, metallic stents.”
Material from Reuters was used in this report.