Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy

MedStar Health

Status: Completed

Conditions: Incidence of Major Adverse Cardiac Events

Treatments: Other: PCI with Synergy Stent

Study type: Observational

Funder types: Other

Identifiers

NCT02823730

REWARDS-Synergy

Details and patient eligibility

About

To compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer.

Full description

The primary objective of this observational, real-world single-center registry is to compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer. The investigators hypothesize that the long-term incidence (each year following implantation, up to 4 years) of major adverse cardiovascular events, after propensity matching for stent type, will be similar between Synergy and Xience V.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject >18 years of age
2. Underwent PCI with Synergy (alone) DES

Exclusion criteria

1. Underwent PCI with a non-Synergy DES (or scaffold) during the same index procedure
2. Patients not taking, or unable to take, dual antiplatelet therapy (DAPT) at the time of screening for the study (patients that discontinue DAPT after enrollment will be included)

Trial design

500 participants in 2 patient groups

Synergy Stent Cohort

Description:

Retrospective registry of 500 patients who have received the Synergy stent. Data will be mined from the DES registry database for the identified Synergy patients at the following time points, in-hospital and then at 1 year, 2 years, 3 years, and 4 years after percutaneous coronary intervention (PCI).

Treatment:

Other: PCI with Synergy Stent

Xience V Cohort

Description:

500 patients that are propensity matched to the 500 patients that underwent PCI with a Synergy stent, eligible for similar time points of follow-up following the PCI.