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FDA Approves First Bioabsorbable Polymer DES
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Boston Scientific announced that the FDA has approved its bioabsorbable polymer drug-eluting stent system for treatment of CAD.
The system (Synergy, Boston Scientific) is the first bioabsorbable DES approved in the United States, according to a company press release.
Dean J. Kereiakes
“Both the drug, everolimus, and the polymer … are fully absorbed shortly after the drug completes elution at 3 months,” Dean J. Kereiakes, MD, FACC, medical director at The Christ Hospital Heart and Vascular Center/The Linder Research Center, Cincinnati, and a member of the Cardiology Today’s Intervention Editorial Board, said during a press conference. “These two processes are in parallel and are 90% complete within 90 days, which allows for the vessel to heal and provides patients with freedom from long-term polymer exposure, potentially reducing the risk of long-term complications. … The approval of Synergy is an important development for cardiologists and patients. I’m looking forward to having it commercially available for use in the United States.”
Favorable results
Approval was based in part on results of the EVOLVE II trial, in which the system was shown to be noninferior to a durable polymer EES (Promus Element Plus, Boston Scientific) for the primary outcome of target lesion failure at 12 months, and in which no patients assigned to receive the bioabsorbable EES had definite stent thrombosis at 24 hours, Kereiakes, who was principal investigator for the trial, said during the conference. In addition, 4-year data from the EVOLVE trial demonstrated a 0% rate of stent thrombosis and a target lesion revascularization rate of 1.1% in patients who received the bioabsorbable EES, according to the company release.
“The trial included the most complex patient population ever studied in a regulatory approval trial for a coronary stent in the United States, that I think is representative of the types of patients we treat in everyday practice,” Kereiakes said. He noted that 25.9% of patients had non-STEMI, 33.9% had unstable angina and 76.8% had complex B2/C lesion morphologies. Approximately one-quarter of patients had reference vessel diameters < 2.25 mm and approximately one-third were being treated for diabetes. “What’s really encouraging is that Synergy was designed to reduce the risk of late events, particularly catastrophic events like stent thrombosis. There was no definite stent thrombosis beyond the first 24 hours, and no definite or probable stent thrombosis after day 6.”
Broad use possible
Ian Meredith, AM, MBBS, PhD, director of MonashHeart, Monash Medical Centre and Monash University, Melbourne, Australia, said at the press conference that the bioabsorbable stent can be used in a wide variety of patients because it is safe and effective for simple and complex lesions. It is currently being used that way in Australia, where it was previously approved, he said.
“We don’t tend to use it for specific groups of patients; we just use it as a workhorse,” Meredith, principal investigator of EVOLVE and co-principal investigator of EVOLVE II, said. “It’s lower profile, it’s more flexible and the polymer is gone within 90 days.”
According to the company statement, the EVOLVE DAPT study, which will evaluate the safety of 3-month dual antiplatelet therapy in patients at high risk for bleeding undergoing PCI with the bioabsorbable EES, is underway. – by Erik Swain
Disclosure: Kereiakes and Meredith report consulting for Boston Scientific.
Perspective
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Stephen G. Ellis, MD
This is a device that needs more long-term follow-up, similar to the bioresorbable vascular scaffold (Absorb, Abbott Laboratories). I say that because the 12-month results were pretty much the same between the bioabsorbable DES and the comparator, a durable polymer EES. The lure, of course, is that the polymer goes away and there may be clinical benefit after that happens. We need more data about that. It’s an interesting concept, and an intriguing device that I don’t think would warrant a price premium, because nothing really has been demonstrated long-term.
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