The Food and Drug Administration has approved Synergy, first coronary stent with a bioabsorbable polymer on the U.S. market, Boston Scientific announced.
Synergy is a platinum chrome stent that uses the polymer PLGA as the biodegradable carrier to deliver the antirestenosing agent everolimus. Polymers have been identified as potential contributors to coronary artery restenosis after stent deployment, at least partly due to their contribution to a proinflammatory state.
Dr. Roxana Mehran
The new stent, which carries the CE mark and has been in use in several European countries since 2013, was studied in the United States in the pivotal EVOLVE II clinical trial, which was a randomized, multicenter trial of 1,684 patients. That trial met its primary endpoints of noninferiority in safety and efficacy when compared to a drug-eluting stent that used a durable polymer (Circ Cardiovasc Interv. 2015 Apr 8. doi: 10.1161/CIRCINTERVENTIONS.114.002372).
EVOLVE II’s primary efficacy endpoint was a combined measure of cardiac death, myocardial infarction with ischemia from a stented artery, or ischemia-driven target vessel revascularization. The Synergy arm saw 6.7% of patients experiencing one of these events, compared with 6.5% of the durable-polymer stent patients. This difference was not statistically significant.
The primary safety outcome of definite or probable stent thrombosis was seen in three patients with the resorbable polymer stent and in five patients with durable polymer stents. This was also a nonsignificant difference.
In EVOLVE II, procedures using Synergy were slightly more likely to be immediately successful than those using the durable polymer stent, with 98.3% vs. 96.9% immediate success rates.
“I’m very excited to have the next generation of the next generation” of stents available as a choice for patients, Dr. Roxana Mehran, professor of medicine and an interventional cardiologist at Mt. Sinai Hospital in New York, said in an interview. She noted that the data are strong, and expects that this stent will prove to be safe and efficacious. But removing the presumed “bad actor” of the proinflammatory durable polymer, she said, may also afford an opportunity to shorten the duration of antiplatelet therapy (DAPT).
She called for a prospective randomized, controlled trial of a shorter duration of DAPT, emphasizing real-world considerations. “Our patients are real people,” she said. “They might need a colonoscopy, spine surgery, knee surgery, dental implants.” The sooner patients can safely stop DAPT, the better, for the mostly elderly population that will be receiving the stents, she said. “It’s very exciting, but I still think we have a ways to go.”
EVOLVE II was sponsored by Boston Scientific, the manufacturer of Synergy. Dr. Mehran has received honoraria from and has been a consultant to Boston Scientific as well as several other device and drug companies.
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