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

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

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.

Study Overview

• Status: Completed
• Conditions: Incidence of Major Adverse Cardiac Events
• Intervention / Treatment: Other: PCI with Synergy Stent

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a single-center, observational, 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).

The 500 patients that underwent PCI with a Synergy stent will then be compared to a propensity matched Xience V cohort eligible for similar time points of follow up following the PCI.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Synergy Stent Cohort; 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).	Other: PCI with Synergy Stent; 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).
Xience V Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events (MACE)	major adverse cardiac events (MACE), defined as the composite of: 1. All-cause death; 2. Q-wave myocardial infarction (QwMI): appearance of new pathologic Q waves in the coronary distribution of the target vessel with an increase of creatine kinase-MB to ≥2 times the reference values (if available); 3. Target vessel revascularization (TVR): need for repeat PCI within the target vessel.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization	Need for repeat PCI within the target lesion	4 years
Periprocedural creatine kinase-MB	peak level of in-hospital CK-MB post-PCI	4 years
Cardiac death	Any death due to a cardiovascular cause	4 years
Stent thrombosis	Probable or definite stent thrombosis occurring in the target vessel.	4 years

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimated): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REWARDS-Synergy