- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00375063
Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study)
Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Malopolskie
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Krakow, Malopolskie, Polen, 31-147
- Jagiellonian University
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Silesia
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Katowice, Silesia, Polen, 40-635
- Silesian Medical School 1-st Department of Cardiosurgery
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Katowice, Silesia, Polen, 40-635
- Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit
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Pennsylvania
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Bryn Mawr, Pennsylvania, Vereinigte Staaten, 19010
- Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78248
- San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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LV function assessed by 2D echocardiography
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exercise tolerance measured with ECG treadmill stress testing
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angina severity according to CCS classification 12 months after the index intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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Dauer des Krankenhausaufenthaltes
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30 day and one year major adverse events (MAE)
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30 day and one year major acute cardiovascular events (MACE)
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one year and total survival and freedom from MACE
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one year target vessel failure (TVF).
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Pawel E Buszman, Prof, Silesian Medical School, Poland
- Hauptermittler: Stefan R Kiesz, Prof, 2San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio, Tx, USA,
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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. doi: 10.1038/ncpcardio0272.
- 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. doi: 10.1161/01.CIR.0000155256.88940.F8. Epub 2005 Feb 7.
- 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. doi: 10.1016/j.jacc.2004.10.039.
- 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. doi: 10.1161/01.CIR.0000158486.20865.8B.
- Peszek-Przybyla E, Buszman P, Bialkowska B, Zurakowski L, Banasiewicz-Szkrobka 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.
- Buszman PE, Kiesz SR, Bochenek A, Peszek-Przybyla E, Szkrobka I, Debinski M, Bialkowska B, Dudek D, Gruszka A, Zurakowski A, Milewski K, Wilczynski M, Rzeszutko L, Buszman P, Szymszal J, Martin JL, Tendera M. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol. 2008 Feb 5;51(5):538-45. doi: 10.1016/j.jacc.2007.09.054.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 6 P05B 132 21
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