Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)

Study Overview
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Brief Summary
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The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the real world daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).

Detailed Description
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This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.

Official Title
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Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Xience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients received XIENCE stents The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: Patients with a mixture of other DESs Terminal illness with life expectancy <1 year. Patients with cardiogenic shock

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xience stent<br>Real world patients treated with XIENCE stents | Device: Xience<br>* Patients with Xience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR) | composite of death, nonfatal myocardial infarction (MI), or ischemic driven Target Vessel Revascularization (TVR). Individual events are to be assessed as secondary. | at 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Cardiac death | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| MI | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Composite of death or MI | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Composite of cardiac death or MI | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| TVR | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Target-lesion revascularization (TLR) | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Stent thrombosis (ARC criteria) | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 1month ,6 month and 12 months,2year,3year,4 year and 5year | 
| Procedural success | defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization | at discharge |