Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI with Synergy Stent | Other | 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). |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | United States |
Not provided
Not provided
Not provided
Not provided
|
| 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 |