SYNERGY™ & SYNERGY MEGATRON™

EES PtCr Coronary Stent System

SYNERGY in Short DAPT Trials1-6

Synergy in Short DAPT trials

Boston Scientific is continuing to invest in the science to address a significant clinical unmet need with shortened DAPT.

SYNTAX II High Bleeding Risk Other Clinical Studies Clinical Program Overview
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SYNERGY BP-DES was intentionally designed to enable short DAPT

Hear more from Dr. Aloke Finn talking to Dr. Robert Yeh at TCT 2019
Webcast Aloke
Video courtesy of TCTMD
 

EVOLVE Short DAPT

 Investing in addressing a significant healthcare challenge

Purpose

To define the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with the SYNERGY Stent System.

Design

Prospective, multicenter, single-arm study.
Required clinical follow-up: 3 months, 6 months, 12 months and 15 months post-index procedure.

Endpoints

Co-Primary Endpoints: ARC definite/probable ST and Death/MI between 3-15 months.
Secondary Endpoint: Bleeding Academic Research Consortium (BARC) bleeding Type 2, Type 3, and Type 5 between 3-15 months (patients not on chronic anticoagulation).

Progress to Date

Primary endpoint data presented at TCT 2019.
EVOLVE Short DAPT Trial

SENIOR

Purpose

To study 1- month DAPT in stable elderly patients and 6-month DAPT in unstable
elderly patients undergoing PCI with the SYNERGY™ BP-DES or REBEL™ BMS.

Design

Randomized, prospective, multicenter, single-blind
Required clinical follow-up:  1 month, 6 months, 1 year and 2-years post index procedure.

Endpoints

Primary Endpoints: The rate of MACE defined as death from any cause, MI, ischemia-driven target vessel revascularization (TVR) or stroke
Secondary Endpoint: ARC def/prob ST, BARC - Type 2, Type 3, and Type 5

Progress to Date

No. of patients: 1200
12 month primary endpoint data was released at TCT 2017; Data specific to 1-month DAPT cohort was released at EuroPCR 2018. 2-year results were presented at TCT 2018.
       

ASET

0-Month DAPT In Patients With Chronic Stable Angina

Purpose

Acetyl Salicylic Elimination Trial. To evaluate the feasibility and safety of a single antiplatelet therapy with prasugrel, starting immediately after successful PCI with SYNERGY™ BP Stent (i.e. no DAPT; aspirin-free monotherapy).

Design

Prospective, multicenter, single arm, proof-of-concept, open-label study
N=200 chronic stable angina patients in Brazil
Required clinical follow-up: 1 month, 3 months and 4 months post-index procedure

Endpoints

Primary Ischemic Endpoint: Composite of cardiac death, target-vessel MI (spontaneous >48 hours) or definite stent thrombosis at 3 months
Primary Bleeding Endpoint: BARC Type 3, Type 5 bleeding at 3 months

Progress to Date

3-month primary endpoint results presented at TCT 2019.
       

IDEAL LM

SYNERGY ™ BP Stent vs. XIENCE™ Stent in Left Main PCI

Purpose

Improved Drug Eluting Stent for Percutaneous Coronary Intervention of the Left Main Artery in a Real World All-comers Population.
Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the SYNERGY BP Stent or to the Xience stent. Dual antiplatelet therapy (DAPT) will be stopped at 4 months in the SYNERGY BP Stent arm whereas in the control arm DAPT will be continued for 12 months.

Design

Prospective, randomized, multicenter study
N=818 patients randomized 1:1 to LM PCI with either the SYNERGY BP Stent or the Xience Stent
Required clinical follow-up: 6,12 and 24 months

Endpoints

Primary Endpoint: Rate of MACE defined as death from any cause or MI or ischemia-driven TVR at 2 years post-procedure
Secondary Endpoints: Individual components of the primary endpoint; DOCE (cardiac death, MI not clearly attributable to a non-target vessel, and clinically-indicated TLR at 1m, 6m and annually through 3y); ARC Definite/Probable ST; Composite of BARC 3 or 5 bleeding at 24 months

Progress to Date

2-year primary endpoint results presented at TCT 2019
       

POEM

Bioabsorbable Polymer-Coated EES in Patients at HBR Undergoing PCI Followed by 1-Month DAPT

Purpose

To evaluate the safety of bioabsorbable polymer-coated everolimus-eluting SYNERGY™ BP Stent followed by 1-month DAPT in coronary artery disease patients at high risk for bleeding who qualify for PCI

Design

Prospective, single-arm, multicenter trial, powered for non-inferiority with respect to objective performance criteria (OPC); n=1,023 across 10 centers in Italy

Endpoints

Primary Endpoint: The rate of MACE (composite of cardiac death, MI and definite/probable ST) at 1 year
Secondary Endpoints: Components of primary endpoint, as well as all-cause death, TVR, TLR, major bleeding (BARC 3/5), cerebrovascular event and TLF, at 30 days and 1 year; patient-oriented composite endpoint (composite of any death, any MI, and revascularization) at 30 days and 1 year

Progress to Date

Enrollment in progress.
       

SYNIVUS-DAPT

SYNERGY BP Stent and IVUS with 1-Month DAPT in HBR Patients

Purpose

To investigate if 1-month DAPT combined with the placement of the SYNERGY™ BP Stent with IVUS is safe for patients who are at high risk of bleeding

Design

Prospective, multicenter, single-arm, open label trial
n=100 (U.S.)

Endpoints

Co-Primary Endpoint: Rate of cardiac death at 1 to 13 months (in the “as treated” (eligible for 30 days DAPT cessation) population); Rate of myocardial infarction 1 to 13 months (in the overall enrolled “intent-to-treat” patent population)
Secondary Endpoints: Rate of ARC definite/probable ST, rate of major bleeding, ischemia-driven TLR, ischemia-driven TVR, TLF, TVF, all-cause death and all-cause MI at 1 to 13 months

Progress to Date

Enrollment in progress.
       
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Optimal Healing

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Real-World Studies

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