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

Completed

• Conditions: Incidence of Major Adverse Cardiac Events
• Interventions: Other: PCI with Synergy Stent

• Registration Number: NCT02823730
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Status Verified: 2023-05
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Synergy Stent Cohort	PCI with Synergy Stent	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).

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	4 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States