In the first successful US pivotal trial of a bioabsorbable polymer stent, the Boston Scientific 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, favourable rates for key secondary endpoints were observed with the SYNERGY stent. Dean Kereiakes, the principal investigator for the EVOLVE II trial, presented the study results in a late breaking clinical trial session at the American Heart Association Scientific Session 2014 in Chicago, USA.
Key findings for the SYNERGY stent from the EVOLVE II trial include the following:
- At 12 months, the TLF rate was 6.4% per protocol (p=0.0003 for non-inferiority) and 6.7% for intent-to-treat (p=0.0005 for non-inferiority)
- Stent thrombosis was rare, with definite or probable stent thrombosis occurring in only 0.4% of patients through one year. No Definite stent thrombosis 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,” says Kereiakes, who is medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati.
The EVOLVE II trial is a global, multi-centre, 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 USA, 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% of patients had non-stent thrombosis elevation myocardial infarction (NSTEMI) and approximately 75% of patients had AHA/ACC class B2 or C coronary lesions. The EVOLVE II trial is part of a clinical program designed to support US Food and Drug Administration (FDA) and Japanese Ministry of Health, Labour and Welfare (MHLW) approval of the SYNERGY stent.
“The EVOLVE II trial adds to our growing body of knowledge about the SYNERGY bioabsorbable polymer stent, which is designed to provide early healing and freedom from long-term polymer exposure,” says 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.”