Everolimus Stent in Patients With Coronary Artery Disease (CAD)

Study Overview
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Brief Summary
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Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Detailed Description
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Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.

Official Title
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Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease, Coronary Atherosclerosis

Intervention / Treatment
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* Device: coronary stent
* Device: stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI) Exclusion Criteria: Contraindication to dual antiplatelet therapy for 12 months Known allergy to sirolimus or everolimus Major surgical procedure planned within 1 month History, symptoms, or findings suggestive of aortic dissection. Participation in other trials Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EES Group<br>Patients who received an everolimus eluting stent | Device: coronary stent<br>* coronary angioplasty with stent implantation<br>* Other names: XIENCE V drug eluting stent; Abbot Vascular USA;|
| Active Comparator: SES Gruop<br>Patients who received a sirolimus eluting stent | Device: stent<br>* coronary angioplasty with stent implantation<br>* Other names: CYPHER drug eluting stent; Johnson & Johnson USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Revascularization | Incidence of clinically driven target vessel revascularization at 2 year follow up | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death | incidence of death for cardiac causes at 2 year | 2 year | 
| non fatal myocardial infarction | incidence of non fatal Q or non Q wave reinfarction at 2 year | 2 year | 
| stent thrombosis | incidence of definite, probable or possible stent thrombosis at 2 year | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty