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

Launched by MINISTRY OF SCIENCE AND HIGHER EDUCATION, POLAND · Sep 11, 2006

Keywords

ClinConnect Summary

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 wit...

Gender

ALL

Eligibility 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.