EVOLVE II Trial Represents the First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Stent
In the first successful U.S. pivotal trial of a bioabsorbable polymer stent, the Boston Scientific (NYSE: BSX) 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 percent per protocol (p=0.0003 for non-inferiority) and 6.7 percent 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 percent 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, randomized, 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 U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. Patients demonstrated both clinical and angiographic complexity to a degree not observed in prior U.S. pivotal trials for DES. More than 25 percent of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75 percent of patients had AHA/ACC class B2 or C coronary lesions.
The EVOLVE II Trial is part of a rigorous clinical program designed to support U.S. Food and Drug Administration (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.”