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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375063
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : September 12, 2006
Information provided by:
Ministry of Science and Higher Education, Poland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenosis Myocardial Revascularization Myocardial Ischemia Procedure: Percutaneous Coronary Intervention Procedure: Coronary Artery Bypass Grafting Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery
Study Start Date : January 2001
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. LV function assessed by 2D echocardiography
  2. exercise tolerance measured with ECG treadmill stress testing
  3. angina severity according to CCS classification 12 months after the index intervention

Secondary Outcome Measures :
  1. 30 day and one year major adverse events (MAE)
  2. 30 day and one year major acute cardiovascular events (MACE)
  3. length of hospitalization
  4. one year and total survival and freedom from MACE
  5. one year target vessel failure (TVF).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375063

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United States, Pennsylvania
Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia
Bryn Mawr, Pennsylvania, United States, 19010
United States, Texas
San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78248
Jagiellonian University
Krakow, Malopolskie, Poland, 31-147
Silesian Medical School 1-st Department of Cardiosurgery
Katowice, Silesia, Poland, 40-635
Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit
Katowice, Silesia, Poland, 40-635
Sponsors and Collaborators
Ministry of Science and Higher Education, Poland
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Principal Investigator: Pawel E Buszman, Prof Silesian Medical School, Poland
Principal Investigator: Stefan R Kiesz, Prof 2San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio, Tx, USA,
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00375063    
Other Study ID Numbers: 6 P05B 132 21
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: September 12, 2006
Last Verified: September 2006
Keywords provided by Ministry of Science and Higher Education, Poland:
left main stenosis
Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Stenosis
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease