FDA approves first bioabsorbable polymer drug-eluting stent system

The FDA approved the Synergy bioabsorbable polymer drug-eluting stent system on Oct. 5 to treat coronary artery disease.

The Synergy stent is the first FDA-approved bioabsorbable polymer drug-eluting stent system, according to Boston Scientific, its manufacturer. The stent was approved in Europe in 2012.

The stent is designed to reduce the risk of complications associated with long-term polymer exposure compared with drug-eluting stents with permanent polymers that remain on the stents after the drug is delivered.

The approval was based on results of the EVOLVE II trial, which enrolled 1,684 patients in 2012 and 2013 who had non-STEMI or stable coronary artery disease and were scheduled to undergo PCI.

The researchers found that the Synergy stent was noninferior to the Promus Element everolimus-eluting stent. At one year, 6.7 percent of patients in the Synergy group and 6.5 percent of patients in the Promus group had target lesion failure, which the researchers defined as ischemia-driven revascularization of the target lesion, MI related to the target vessel or cardiac death.

The Synergy and Promus groups had similar rates for revascularization and definite/probable stent thrombosis, as well.

At four years, trial data showed a continued 0 percent stent thrombosis rate and a 1.1 percent target lesion revascularization rate, according to Boston Scientific. The company said it plans on initiating the EVOLVE short dual antiplatelet therapy study in the first quarter of 2016. The trial will examine the safety of three-month use of dual antiplatelet therapy in patients at high risk for bleeding undergoing PCI with the Synergy stent.

“The metallic drug-eluting stents with no polymer or with a bioabsorbale polymer have a high bar to go against because the current U.S.-approved drug-eluting stents before today’s Synergy announcement, all of which had durable polymers, have gotten very, very good one-year results and long-term results,” said Gregg W. Stone, MD, a professor of medicine at Columbia University. “We don’t even know if these new metallic drug-eluting stents are better than the other approved, durable polymer drug–eluting stents and we don’t know if the bioresorbable scaffolds are as good within one year and then whether they’ll be superior within five years. Only very large-scale, multicenter, randomized trials will be able to give us that answer, but those studies are underway.”