In the first successful US pivotal trial of a bioabsorbable polymer stent, the Boston Scientific Synergy Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium Coronary Stent System met its primary endpoint in this non-inferiority study, which evaluated the one-year rate of target lesion failure (TLF).
Additionally, favorable rates for key secondary endpoints were observed with the Synergy Stent. Dean Kereiakes, M.D., F.A.C.C., F.S.C.A.I., the principal investigator for the EVOLVE II Trial, presented the study results today in a Late Breaking Clinical Trial session at the American Heart Association Scientific Session 2014 in Chicago.
Key findings for the Synergy Stent from the EVOLVE II Trial include the following: At 12 months, the TLF rate was 6.4 per cent per protocol (p=0.0003 for non-inferiority) and 6.7 per cent for intent-to-treat (p=0.0005 for non-inferiority).Stent Thrombosis (ST) was rare, with Definite or Probable ST occurring in only 0.4 per cent of patients through one year. No Definite ST occurred after 24 hours.
"The one-year data from the EVOLVE II Trial, particularly the exceptionally low stent thrombosis rate, are encouraging because this is a complex patient population," said Kereiakes, who is medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati. "Having a bioabsorbable polymer stent with this type of performance is important to physicians and health care 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 is a global, multi-center, randomised, single-blind, non-inferiority pivotal trial designed to evaluate the performance of the Synergy Stent System compared to the durable polymer PROMUS Element™ Plus Drug-Eluting Stent (DES) System. The trial enrolled 1,684 patients in 125 sites worldwide, including the US., Canada, Europe, Australia, New Zealand, Japan and Singapore. Patients demonstrated both clinical and angiographic complexity to a degree not observed in prior US pivotal trials for DES. More than 25 per cent of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75 per cent of patients had AHA/ACC class B2 or C coronary lesions. The EVOLVE II Trial is part of a rigorous clinical programme designed to support US Food and Drug Administration (US FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the Synergy Stent.
"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," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "It also supports key findings from the EVOLVE FHU study, where data through three-years demonstrate excellent long-term outcomes."
If approved by the FDA, the Synergy Stent would become the first bioabsorbable polymer stent available to patients in the US It features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months, thereby eliminating long-term polymer exposure. The Synergy Stent is being investigated in multiple independent, "real-world" studies across the spectrum of cardiovascular disease complexity.
The Synergy Stent is an investigational device in the US and Japan, and is not available for sale in those countries. The Synergy Stent has CE mark approval and is available for sale in Europe.
Coronary artery disease is a narrowing of blood vessels that supply blood and oxygen to the heart. Patients with coronary artery disease may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.