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

This study has been completed.
Sponsor:
Information provided by:
Ministry of Science and Higher Education, Poland
ClinicalTrials.gov Identifier:
NCT00375063
First received: September 11, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Artery Stenosis
Myocardial Revascularization
Myocardial Ischemia
Procedure: Percutaneous Coronary Intervention
Procedure: Coronary Artery Bypass Grafting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Ministry of Science and Higher Education, Poland:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 130
Study Start Date: January 2001
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375063

Locations
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
Poland
Jagiellonian University
Krakow, Malopolskie, Poland, 31-147
Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit
Katowice, Silesia, Poland, 40-635
Silesian Medical School 1-st Department of Cardiosurgery
Katowice, Silesia, Poland, 40-635
Sponsors and Collaborators
Ministry of Science and Higher Education, Poland
Investigators
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,
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00375063     History of Changes
Other Study ID Numbers: 6 P05B 132 21
Study First Received: September 11, 2006
Last Updated: September 11, 2006
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Ministry of Science and Higher Education, Poland:
left main stenosis
Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting

Additional relevant MeSH terms:
Constriction, Pathologic
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Coronary Stenosis
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014