EVOLVE II Data Presented for Boston Scientific's Synergy Bioabsorbable Polymer Stent

November 19, 2014—Boston Scientific Corporation announced that principal investigator Dean Kereiakes, MD, presented results from the EVOLVE II trial in a late-breaking clinical trial session at the American Heart Association Scientific Session 2014 in Chicago, Illinois.

The EVOLVE II study is evaluating the company’s Synergy everolimus-eluting, bioabsorbable polymer, platinum chromium coronary stent system.

According to the company, the study met its primary endpoint for the 1-year rate of target lesion failure (TLF). Additionally, favorable rates for key secondary endpoints were observed with the Synergy stent. At 12-months in EVOLVE II, the Synergy stent demonstrated a TLF rate of 6.4% per protocol (P = .0003 for noninferiority), a 6.7% TLF rate for intent-to-treat (P = .0005 for noninferiority), and a 0.4% rate of definite or probable stent thrombosis. No definite stent thrombosis occurred after 24 hours.

In Boston Scientific’s press release, Dr. Kereiakas commented, “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.” He added, “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.” Dr. Kereiakes is Medical Director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center in Cincinnati, Ohio.

The EVOLVE II trial is a global, multicenter, randomized, single-blind, noninferiority pivotal trial designed to evaluate the performance of the Synergy stent system compared to the company’s 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. 

According to the company, patients enrolled in EVOLVE II demonstrated both clinical and angiographic complexity to a degree not observed in previous United States pivotal trials for DES. More than 25% of patients had non-ST elevation myocardial infarction and approximately 75% of patients had American Heart Association/American College of Cardiology class B2 or C coronary lesions. 

The Synergy device features ultra-thin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at 3 months, thereby eliminating long-term polymer exposure. In the United States and Japan, the Synergy stent is an investigational device and is not available for sale. The Synergy stent has received CE Mark approval and is available for sale in Europe, as well as select markets in Asia.

The Synergy stent is being investigated in multiple independent, real-world studies across the spectrum of cardiovascular disease complexity. The EVOLVE II Trial is part of the company’s clinical program designed to support US Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the Synergy stent. The EVOLVE II data support key findings from the EVOLVE first-human-use study, in which data through 3 years have demonstrated excellent long-term outcomes, noted the company.

In May 2014, Professor Ian Meredith, MD, presented 3-year follow-up data from the EVOLVE clinical trial at the EuroPCR 2014 congress in Paris, France.