News | December 10, 2014

EVOLVE II Trial Shows Promising Results for Boston Scientific’s Synergy Stent System

Completion represents the first successful pivotal trial of a bioabsorbable polymer stent in the United States

Boston Scientific, EVOLVE II, Synergy, bioresorbable stent

December 10, 2014 — In the first successful United States 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 Synergy. Dean Kereiakes, M.D., FACC, FSCAI, principal investigator for the EVOLVE II Trial, presented the study results in a session at the American Heart Association Scientific Session 2014 in Chicago.

Key findings 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.”

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 United States, Canada, Europe, Australia, New Zealand, Japan and Singapore. 

For more information: www.bostonscientific.com

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