Incidence of Major Adverse Cardiac Events
Conditions
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.
Interventions
OTHERPCI 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).
Sponsors
Medstar Health Research Institute
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cardiac death | 4 years | Any death due to a cardiovascular cause |
| Stent thrombosis | 4 years | Probable or definite stent thrombosis occurring in the target vessel. |
Countries
United States
Outcome results
None listed