Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study)

Study Overview
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Brief Summary
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Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery.

Detailed Description
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The natural history and the results of pharmacological treatment in patients with severe narrowing of left main coronary artery show very poor prognosis (5 year survival less than 50%). There is general agreement that surgical treatment improves 5 year survival in patients with left main coronary artery obstruction 3, however long term survival rate (15 year follow-up) is low in both groups (37% and 27% respectively in surgical and medical group). Median survival was longer in surgical group in general population (13.3 vs 6.6 years) , but there was no significant difference in patients with normal LV ejection fraction (14.7 vs 15 years). With the advent of coronary stenting encouraging results were reported by several authors. There was high success rate 98-100% for elective procedures and in these series the mortality (for protected and non-protected left main) ranged from 0 to 3.4 %, and 6 month event free survival rate was 70-80%. Restenosis rate in stented LM varied from 10-22% for proximal LM to 40% for distal LM. Final minimal luminal area >=7mm2 post procedure, assessed by IVUS, predicted low restenosis rate of 7%, while the area below <7mm2 was connected with restenosis of 50%. Our and other experience showed that left main in-stent restenosis can be treated successfully with another percutaneous intervention (including endarterectomy and balloon angioplasty) as well as by surgical revascularization. Six and 12-month survival rate depended on the LV function. Patients with LVEF>40% had in-hospital event free survival of 98% and 9-month event free survival of 86%, whereas patients with LVEF <40% had in-hospital and 9 month event-free survival of 67 and 22% respectively. Additionally, in patients presented with acute myocardial infarction or bail-out procedures, early and late results of LM stenting were not as good as for elective cases. Our previously presented promising results of left main stenting is mainly related to proper technique of LM stenting (short inflations within LM, careful guiding catheter manipulation, stent selection), as well as very cautiously designed follow-up (every month visit for first six month, routine coronary angiography within 3-6 months after procedure). This initial experience gives us the backgrounds for a larger prospective randomized trial comparing elective surgical revascularisation and percutaneous intervention in patients with LM coronary artery disease. It is our impression that design and the delivery system of the new generation stent is uniquely suited to safely treat this difficult subset of patients. At the present time we would limit the study to the discrete lesions in proximal (ostial and mid) left main with reference luminal diameter >=3 mm. Based on published results of stenting under IVUS examination for such a lesion we estimate the restenosis rate to be well below 10%. As we expect, the survival and complication rate within one year in both group will be similar. Therefore our main concern is weather both treatment strategies will offer the same prevention of LV function, as well as improvement of functional capacity and coronary reserve in both groups in a period of 2-3 years.

Official Title
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Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery

Conditions
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Coronary Artery Stenosis, Myocardial Revascularization, Myocardial Ischemia

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Procedure: Coronary Artery Bypass Grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients' age 18 to 80 Significant LM stenosis (>50%) The target vessel reference diameter 2.5mm. Concomitant multivessel disease suitable for PCI is allowed. The patient is an acceptable candidate for coronary artery bypass surgery. The patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram. The patient written informed consent. Exclusion Criteria: An allergy or contraindication to aspirin, ticlopidine or Clopidogrel. Presence of diffuse, significant (>++) calcifications in LM Left ventricular ejection fraction < 35% History of bleeding diathesis or coagulopathy. Any previous PCI or CABG surgery Acute MI within 48 hours, cardiogenic shock. Bail-out stenting of dissected LM during complicated PCI. The patient suffered a stroke or transient ischemic neurological attack (TIA) within 3 months. Chronic renal insufficiency. Positive pregnancy test. Any disease that may shorten the life expectancy of the patient. The patient is currently participating in another research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous Coronary Intervention|nan|
|Procedure: Coronary Artery Bypass Grafting|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV function assessed by 2D echocardiography |  |  | 
| exercise tolerance measured with ECG treadmill stress testing |  |  | 
| angina severity according to CCS classification 12 months after the index intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day and one year major adverse events (MAE) |  |  | 
| 30 day and one year major acute cardiovascular events (MACE) |  |  | 
| length of hospitalization |  |  | 
| one year and total survival and freedom from MACE |  |  | 
| one year target vessel failure (TVF). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left main stenosis, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting