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

Myocardial Ischemia Clinical Trial

Official title:

Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375063
• Other study ID #: 6 P05B 132 21
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2006
• Last updated: September 11, 2006
• Start date: January 2001
• Est. completion date: December 2005

Study information

• Verified date: September 2006
• Source: Ministry of Science and Higher Education, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis
• Myocardial Ischemia
• Myocardial Revascularization

Intervention

Procedure:
• Percutaneous Coronary Intervention

• Coronary Artery Bypass Grafting

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Higher Education, Poland

Countries where clinical trial is conducted

United States,  Poland, 

References & Publications (5)

Chieffo A, Colombo A. Treatment of unprotected left main coronary artery disease with drug-eluting stents: is it time for a randomized trial? Nat Clin Pract Cardiovasc Med. 2005 Aug;2(8):396-400. Review. — View Citation

Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano M, Airoldi F, Michev I, Sangiorgi MG, Carlino M, Vitrella G, Colombo A. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Circulation. 2005 Feb 15;111(6):791-5. Epub 2005 Feb 7. — View Citation

Park SJ, Kim YH, Lee BK, Lee SW, Lee CW, Hong MK, Kim JJ, Mintz GS, Park SW. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol. 2005 Feb 1;45(3):351-6. — View Citation

Peszek-Przybyla E, Buszman P, Bialkowska B, Zurakowski L, Banasiewicz-Szkróbka I, Debinski M, Tendera M. Stent implantation for the unprotected left main coronary artery. The long-term outcome of 62 patients. Kardiol Pol. 2006 Jan;64(1):1-6; discussion 7. — View Citation

Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation. 2005 Mar 22;111(11):1383-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV function assessed by 2D echocardiography
Primary	exercise tolerance measured with ECG treadmill stress testing
Primary	angina severity according to CCS classification 12 months after the index intervention
Secondary	30 day and one year major adverse events (MAE)
Secondary	30 day and one year major acute cardiovascular events (MACE)
Secondary	length of hospitalization
Secondary	one year and total survival and freedom from MACE
Secondary	one year target vessel failure (TVF).