Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy (REWARDS-Synergy)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Major adverse cardiac events (MACE)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject >18 years of age
- •Underwent PCI with Synergy (alone) DES
Exclusion Criteria
- •Underwent PCI with a non-Synergy DES (or scaffold) during the same index procedure
- •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)
Outcomes
Primary Outcomes
Major adverse cardiac events (MACE)
Time Frame: 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 Outcomes
- Target lesion revascularization(4 years)
- Periprocedural creatine kinase-MB(4 years)
- Stent thrombosis(4 years)
- Cardiac death(4 years)