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

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.

Official Title
-----------------
Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy (REWARDS-Synergy)

Conditions
-----------------
Incidence of Major Adverse Cardiac Events

Intervention / Treatment
-----------------
* Other: PCI with Synergy Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synergy Stent Cohort<br>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). | Other: PCI with Synergy Stent<br>* 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).<br>|
| Xience V Cohort<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |