SYNERGY™

Everolimus-Eluting Platinum Chromium Coronary Stent System

EVOLVE II Clinical Trial 4-Year Outcomes

The SYNERGY™ BP Stent shows outstanding safety with consistently low ST rates in over 18,000 patients, with various levels of lesion complexity, across 9 studies, consistent with a well-healed artery.
EVOLVE II Clinical Trial 4-Year Outcomes

Most complex patient population ever studied in a U.S. Pivotal Trial

EVOLVE II Clinical Trial Study Overview

Patients with ≤3 native coronary artery lesions in ≤2 major epicardial vessels; lesion length ≤34 mm, RVD ≥2.25 mm ≤4.0, %DS> 50 <100 (excluded LM disease, SVG, CTO, or recent STEMI)

EVOLVE II Clinical Trial Baseline Characteristics for the SYNERGY Stent Arm

EVOLVE II Clinical Trial Baseline Characteristics for the SYNERGY Stent Arm
Kereiakes et al. The EVOLVE II Trial.  Circ Cardiovasc Interv. 2015.

Excellent Safety Performance with SYNERGY BP Stent

4-Year Outcomes

Definite/Probable: ITT Population

Definite/Probable: ITT Population

Presented by R. Lee Jobe, MD at ACC 2018
* CEC confirmed MI/TLR/ST Day 901 in the SYNERGY arm post DCB procedure 

Numerically lower ARC Definite/Probable ST with the SYNERGY Bioabsorbable Polymer DES compared to the PROMUS Element Permanent Polymer DES

ARC Definite/Probable ST Landmark Analysis

ARC Definite/Probable ST Landmark Analysis

*CEC confirmed MI/TLR/ST Day 901 in the SYNERGY arm 37 y/o male patient had 1,1,0 distal RCA/PDA bifurcation lesion, and a second lesion in the mid-LAD treated during the index procedure (patient was discharged on DAPT [clopidogrel].  On day 840, patient had TLR of 75% in-stent restenosis of the distal RCA/PDA lesion performed with drug coated balloon (patient was discharged on DAPT [prasugrel]).  On day 901, patient developed severe chest pain, ST elevation and marked elevation of cardiac enzymes.  Found to have ST of RCA/PDA lesion, which was successfully treated with another stent.

ITT; Patients who did not receive a study stent were censored at 1 year; KM Event Rate; log-rank P values ST occurring between 0 and 1 years have been previously reported in Kereiakes et al. Circ Cardiovasc Interv 2015

ITT; Patients who did not receive a study stent were censored at 1 year; KM Event Rate; log-rank P values

Presented by R. Lee Jobe, MD at ACC 2018 

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