Boston Scientific (NYSE:BSX) said today that its next-generation Synergy stent, featuring a bioabsorbable polymer impregnated with everolimus, is the 1st such device to pass a U.S. pivotal trial.
The 1,684-patient Evolve II trial, comparing Synergy with Boston Scientific’s Promus drug-eluting stent, featured patients with "both clinical and angiographic complexity to a degree not observed in prior U.S. pivotal trials for DES," Boston Scientific said.
The Synergy cohort of the trial showed a 1-year target lesion failure rate of 6.4% per protocol and 6.7% on an intent-to-treat basis, according to a press release. Stent thrombosis was "rare," according to the release, occurring in 0.4% of patients at 12 months; definite stent thrombosis was absent after 24 hours.
The data were presented today at the annual American Heart Assn. meeting in Chicago by principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center/Lindner Research Center. Boston Scientific hopes the results will help it win favor with regulators in the U.S. and Japan, the Marlborough, Mass.-based company said.
“The 1-year data from the Evolve II Trial, particularly the exceptionally low stent thrombosis rate, are encouraging because this is a complex patient population," Kereiakes said in prepared remarks. "Having a bioabsorbable polymer stent with this type of performance is important to physicians and healthcare systems. In addition, there is great enthusiasm for a product that is very deliverable and user-friendly. From an operator perspective, the Synergy stent makes cases easier."
"The Evolve II Trial adds to our growing body of knowledge about the promising Synergy bioabsorbable polymer stent, which is designed to provide early healing and freedom from long-term polymer exposure," added interventional cardiology president Kevin Ballinger. "It also supports key findings from the Evolve FHU study, where data through 3 years demonstrate excellent long-term outcomes."