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

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
New Study Focuses on Protein Responsible For Increased Heart Disease Risk
News | Cardiac Diagnostics| August 03, 2017
August 3, 2017 — A study to reduce the strongest inherited...
Overlay Init