Everolimus-Eluting Platinum Chromium Coronary Stent System

Long-term Safety with the SYNERGY Stent System

SYNERGY EVOLVE Clinical Data Infographic
* In a landmark analysis at 24 hours.
Current guidelines recommend that dual anti-platelet therapy (DAPT) with aspirin and an ADP receptor antagonist be continued for a minimum of 12-months following drug-eluting stent (DES) percutaneous coronary intervention (PCI).
1 Presented by D. Kereiakes, MD at ACC 2016.
2 Meredith, I, AM, MBBS, PhD. PCR 2016. Only the “full dose” SYNERGY Stent results are shown.
3 James, S. Adapted from presentation at TCT 2015.

Synchronous Drug Elution and Polymer Absorption

SYNERGY Stent offers peace of mind knowing the polymer is fully absorbed between 3 and 4-months.1

Exceptional Safety and Performance

Long-term data shows promising results with ZERO ARC definite/probable stent thrombosis and exceptionally low target lesion revascularization out to 5-years.
5-Year Results: 0% ARC Definite/Probable ST and 1.1% TLR at 5-Years2
Three-Year Results

Presented by Ian T. Meredith AM, MBBS, PhD, PCR 2016. Only the “full dose” SYNERGY Stent results are shown.

All Target Vessel MI were NQWMI for both the SYNERGY and PROMUS Element Stents

*One NQWMI in the SYNERGY group was periprocedural. The remaining 2 NQWMI in the SYNERGY arm were considered unrelated to the study device: one at day 347 due to anemia and a major GI bleed, and one at day 364 subsequent  to respiratory failure in a patient with severe COPD – enzymes were checked indicating that a NQWMI had occurred.  The one death was of an unknown cause at day 472 and adjudicated as a Cardiac Death. Safety Population. All p-values are >0.05.

0% Target Lesion Revascularization (TLR) from Six Months to Five Years

EVOLVE II Diabetes Substudy

2-Year Clinical Results

EVOLVE II Diabetes Substudy 2-Year Clinical Results

EVOLVE II  DM Clinical Trial. Presented by Ian T. Meredith AM, MBBS, PhD at PCR 2016.

* Spontaneous MI was defined as the rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the upper reference limit (URL) with ≥1 of the following: symptoms of ischemia, ECG changes, and or evidence of loss of myocardium. Peri-PCI MI was defined by any of the following: i) CK-MB >3X URL within 48 hours, ii) new pathological Q waves, iii) autopsy evidence.  All ST were definite.

^ Cutlip et al, Circulation. 2007; 115(17):2344.