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

September 11, 2006 updated by: Ministry of Science and Higher Education, Poland

Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-147
        • Jagiellonian University
    • Silesia
      • Katowice, Silesia, Poland, 40-635
        • Silesian Medical School 1-st Department of Cardiosurgery
      • Katowice, Silesia, Poland, 40-635
        • Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit
  • United States
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia
    • Texas
      • San Antonio, Texas, United States, 78248
        • San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6 P05B 132 21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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