SYNERGY™

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Everolimus-Eluting Platinum Chromium Coronary Stent System

SYNERGY™ Stent Clinical Overview

The SYNERGY™ BP Stent demonstrates consistently low stent thrombosis rates in over 18,000 patients across 9 studies

ARC ST (Def) Rates for the SYNERGY™ BP Stent17

Low late and very late ST rates across multiple trials.
ARC ST (Def) Rates for the SYNERGY BP Stent
 

Heal With Confidence: Leading in Complex Patients

SYNTAX II Trial

The SYNTAX II Trial utilizing the SYNERGY™ BP Stent, physiological assessment, IVUS guidance, and contemporary state-of-the art PCI techniques demonstrated CABG-like outcomes in patients with three-vessel disease at 3-years.*†¹

Low rates of revascularization, peri-procedural MI, and acute ST suggests that contemporary technologies might help in reducing procedural related complications.

* Angiographically detected.
† The safety and efficacy of the SYNERGY Stent has not been established in patients with 3 vessel disease or CTO lesions
‡ Patient oriented composite endpoint (POCE) is a composite of all-cause death, any stroke, any MI, and any revascularization..

SYNTAX II Trial
 

Zero in on Safety: Stent Thrombosis in Perspective

Kang Network Meta-Analysis

SYNERGY™ BP Stent ranked #1 for the lowest relative risk of Def/Prob ST at 1-year.†15

Kang Network Meta-Analysis

SCAAR Registry

Lowest ST rate compared to newer generation DES (n-DES) despite use in patients with statistically more Class B2/C Lesions, Diabetes, Prior PCI, and 3VD.*‡16

SCAAR Registry

† Caution should be taken in interpreting study results, as some stents had limited numbers of comparisons, and some of the studies had a potential risk of bias. All PtCr-EES stents, also includes PROMUS ElementTM and PROMUS Element PlusTM. Def/prob ST was available in 110 studies with 111,088 patients.

 

‡ Some patients in the SCAAR study were treated for either Left Main, CTO or multi-vessel disease but did not show statistical significance. The safety and efficacy of the SYNERGY BP Stent for those uses has not been established. A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N51,953; Orsiro, N54,946; Promus Element Plus, N5 2,543; Promus Premier, N5 20,414; Xience Xpedition, N5 7,971, Resolute/Resolute Integrity, N519,021; UltimasterTM, N51,156; Resolute Onyx, N56,425) were implanted in 42,357 procedures.

 

§ Cumulative adjusted ARC def ST estimated from Kaplan Meier Curve

 

Leading On Studying Short DAPT

Supporting well-constructed prospective Short DAPT clinical trials with over 5,000 patients to study the SYNERGY™ Stent in various complex patient populations

Leading On Studying Short DAPT
* Investigator-Sponsored Study. Boston Scientific is not responsible for the collection, analysis, or reporting of the investigator-sponsored research output which is the sole responsibility of the investigators. Boston Scientific's involvement in investigator-sponsored research is limited to providing financial support for research that advances medical and scientific knowledge about our products.
t The safety and effectiveness of the SYNERGY BP Stent has not been established in patients with Left Main disease. Please review the SYNERGY DFU for full instructions on use.
 

EVOLVE Short DAPT Trial: Primary Endpoint Results 12 Months Post-DAPT Discontinuation

Studies the safety of discontinuing DAPT at 3-months in high bleeding risk patients using the SYNERGY™ Stent.

 

ARC definite/probable ST
vs. performance goal

Low ARC Def/Prob

0.2% ST Rate

3-month DAPT with SYNERGY™ BP Stent2

ARC definite/probable ST vs. performance goal chart

†† Patients with respective event or sufficient follow-up included in the denominator.

Adjusted death/MI with 3-month DAPT
vs. historical control

3-Month DAPT with SYNERGY™ BP Stent

Non-Inferior

to 12-month DAPT in a historical control

Adjusted death/MI with 3-month DAPT vs. historical control chart

†† Patients with respective event or sufficient follow-up included in the denominator.
‡‡ Worst-case scenario analysis: site-reported MI in control group between 0-12 m assumed within 0-3 m if not CEC adjudicated. Death/MI endpoint is comprised of HBR subjects from HCRI DAPT Study and PROMUS Element post-approval studies that meet the EVOLVE Short DAPT criteria.

 

SENIOR Trial: Studying 1-Month and 6-Month DAPT in Elderly Patients

The SYNERGY™ BP Stent continued to show superior ID-TLR and safety results versus REBEL™ BMS with short BMS-like DAPT regimen at 2-Years.

 

All patients

All patients chart

EVOLVE Short DAPT is a prospective, multicenter, single-arm trial defining the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with the SYNERGY BP Stent. Approximately 74% of patients enrolled discontinued DAPT at 3-months.

1-month DAPT discontinuation cohort§§ 

1-month DAPT discontinuation cohort

SENIOR Trial is a randomized, single-blind trial evaluating the SYNERGY BP Stent and the REBEL BMS in patients 75 years or older with a short duration of DAPT. Over 50% of patients enrolled received a 1-month DAPT regimen.

+ Bleeding Academic Research Consortium {BAR()
§In patients eligible forl-month DAPT in this study. Please review the SYNERGY DFU for full instructions on DAPT.
3. SENIOR Trial. Presented by OlivierVarenne, MD atTCT 2018.

ASET Trial

Studying 0-Month DAPT in Patients with Chronic Stable Angina. 

Safety Data at 3-Months4

Prasugrel monotherapy immediately after SYNERGY™ BP Stent implantation demonstrated encouraging safety in selected patients with low ischemic and bleeding risk.

Zero Definite ST

with the SYNERGY™ BP Stent in
selected patients with low risk stable CAD

ASET is a multicenter, single arm, proof-of-concept trial evauating the feasibility and safety of a single anti platelet therapy with prasugrel, starting immediately after successful PCI with the SYNERGY™ BP Stent (i.e. no DAPT; aspirin-free monotherapy).
 

Excellent Outcomes in Long Lesions

EVOLVE 48 Trial: 1-year results

Supports the safety and effectiveness of the SYNERGY™ 48 mm BP Stent for the treatment of long lesions.†††7

  • 100 patients
  • 15 sites across US, Europe, and New Zealand
  • 100% B2/C lesions
  • 27% diabetes mellitus
 

4.1%

Target lesion failure‡‡‡

 

0%

ARC def/prob ST

 

100%

Technical success

 

100%

Clinical procedure success

 

††† Clinical data conducted with SYNERGY 48 mm, SYNERGY XD’s predecessor device, which can be used to illustrate SYNERGY XD 48 mm clinical data.
‡‡‡ Defined as any ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death

 
 
Exceptional Deliverability

Exceptional Deliverability

Learn about the continued advancement in deliverability that SYNERGY™ offers.

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SYNERGY™ 48 mm

SYNERGY™ 48 mm

Discover the FIRST and ONLY 48 mm DES.

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Early Healing

Early Healing

Find out how synchronous drug elution and polymer absorption enables early healing.

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§ Cumulative adjusted ARC def ST estimated from Kaplan Meier Curve

17. SWEET Registry: Cook TCT 2015., Fribourg Experience: Arroyo CRT 2016. Belfast Experience: Noad TCT 2015., EVOLVE II: Kereiakes, et al. Circ Cardiovasc

Interv. 2015;8:e002372. doi:10.1161/CIRCINTERVENTIONS.114.002372.,EVOLVE FHU: Meredith et al. J Am Coll Cardiol. 2012;59(15):1362., EVOLVE II QCA: Meredith ACC 2015., SCAAR Registry: James TCT 2016 BIO-RESORT presented by Clemens von Birgelen, MD, PhD, TCT 2016. BIORESORT: , Marlies M. Kok et al. Euro Interv.:2018;14-online publish-ahead-of-print May 2018.

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