Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis (LeftMain/NOBLE)
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Purpose
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis.
In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome parameters in patients with unprotected left main (LMCA) disease, treated with coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug eluting stents (DES).
DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate of death.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: Percutaneous coronary intervention Procedure: Coronary artery bypass graft operation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nordic-Baltic-British Left Main Revascularization Study (NOBLE) |
- Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG) [ Time Frame: After 2 years ] [ Designated as safety issue: Yes ]
- Combined endpoint of death, stroke and non-index treatment related MI [ Time Frame: After 1 month and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- Individual endpoints of death, stroke and non-index treatment related MI [ Time Frame: After 1 month and after 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
- New revascularization by CABG or PCI [ Time Frame: After 1, 2 ,3 ,4 and 5 years ] [ Designated as safety issue: Yes ]
- Death [ Time Frame: After 10 years ] [ Designated as safety issue: Yes ]
- Definite stent thrombosis/symptomatic graft occlusion [ Time Frame: Index to 5 years ] [ Designated as safety issue: Yes ]
- CCS angina score [ Time Frame: Index to 5 years ] [ Designated as safety issue: Yes ]
- NYHA functional class [ Time Frame: Index to 5 years ] [ Designated as safety issue: Yes ]
- Duration of admission for index treatment [ Time Frame: Index and 1 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Percutaneous coronary intervention
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis
|
Procedure: Percutaneous coronary intervention
PCI will be performed by the femoral or the transradial approach. In complex distal lesion anatomies, the use of 7-8F guiding catheters and the transfemoral approach may be recommended. Ostial and mid-shaft lesions will be treated with a single stent. For the treatment of distal bifurcation lesions crush, culotte, T-stenting, V-stenting or a single stent strategy may be used according the lesion morphology and the experience of the operator. However, based on the Nordic Bifurcation Studies the culotte technique seems to be associated with especially favorable angiographic and long-term clinical results in these large vessel size bifurcation lesions. There should be a low threshold for the use of high pressure post dilatation balloons. Generally, final kissing balloon dilatations are encouraged and mandatory when two-stent techniques are used. Intravascular ultrasound (IVUS) in mandatory pre and post stent placement. Other Names:
|
|
Active Comparator: Coronary artery bypass graft operation
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis
|
Procedure: Coronary artery bypass graft operation
Patients randomized to the CABG group for the treatment of LMCA stenosis are treated according to current clinical practice. Both off-pump and on-pump techniques can be used and the selection between the used methods is operator dependent. The left internal mammary artery will be used for the revascularization of the left anterior descending coronary artery, whenever feasible. For other lesion location, saphenous venous grafts, free arterial grafts or the right internal mammary artery may be used.
Other Name: CABG
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stable, unstable angina pectoris or ACS.
- Significant lesion* of LMCA ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex** PCI lesions.
- Patient eligible to be treated by CABG and by PCI
- Signed informed consent. *Visually assessed diameter stenosis >50% or fractional flow reserve <0.80. **Length <25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion.
Exclusion Criteria:
- ST-elevation infarction within 24 hours.
- CABG clearly better treatment option (LMCA stenosis and >3, or complex** additional coronary lesions)
- Patient is in too high risk for CABG.
- Expected survival <1 year.
- Allergy to aspirin, clopidogrel or ticlopidine.
- Allergy to Biolimus. **Length >25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion.
Contacts and Locations| Contact: Leif Thuesen, MD, DMSc | +45 7845 0000 ext 52015 | leif.thuesen@ki.au.dk |
| Contact: Per H Nielsen, MD | perhni@rm.dk |
| Denmark | |
| Aarhus University Hospital | Recruiting |
| Skejby, Aarhus N, Denmark, 8200 | |
| Principal Investigator: | Leif Thuesen, MD, DMSc | Aarhus University Hospital |
More Information
No publications provided
| Responsible Party: | Leif Thuesen, MD, Head of the cath. lab., MD, DMSc, Skejby Hospital |
| ClinicalTrials.gov Identifier: | NCT01496651 History of Changes |
| Other Study ID Numbers: | LeftMain/NOBLE |
| Study First Received: | December 19, 2011 |
| Last Updated: | December 22, 2012 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Skejby Hospital:
|
Percutaneous coronary intervention Coronary artery bypass graft operation Left Main |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013