Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.

Detailed Description
-----------------
Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.

Official Title
-----------------
Prospective Randomized Trial of Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease: ISAR-LEFT-MAIN-2

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: Everolimus-eluting stent (Xience)
* Device: Zotarolimus-eluting stent (Endeavor Resolute)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness. Pretreatment with a loading dose of 600 mg clopidogrel. Informed, written consent by the patients or her/his legally-authorized representative for participation in the study. Exclusion Criteria: Cardiogenic shock. ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset. In-stent restenosis. Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance. Prior coronary artery bypass surgery with revascularization of LAD and/or LCx. Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment. Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media. Pregnancy (present, suspected or planned). Patient's inability to fully cooperate with the study protocol.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EES<br>Everolimus-eluting stent (Xience) | Device: Everolimus-eluting stent (Xience)<br>* stent is implanted due to randomization<br>* Other names: Xience;|
| Experimental: ZES<br>Zotarolimus-eluting stent (Endeavor Resolute) | Device: Zotarolimus-eluting stent (Endeavor Resolute)<br>* stent is implanted due to randomization<br>* Other names: Endeavor Resolute;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization. |  | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic restenosis at follow-up coronary angiography. |  | 6-9 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug eluting stent, left main disease