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 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
500
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).
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
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.
Time frame: 4 years
Target lesion revascularization
Need for repeat PCI within the target lesion
Time frame: 4 years
Periprocedural creatine kinase-MB
peak level of in-hospital CK-MB post-PCI
Time frame: 4 years
Cardiac death
Any death due to a cardiovascular cause
Time frame: 4 years
Stent thrombosis
Probable or definite stent thrombosis occurring in the target vessel.
Time frame: 4 years
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