Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis - Full Text View

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)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Coronary Artery Bypass Surgery

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
Primary Completion Date:	January 2015 (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: PCI PTCA
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

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:

PCI
PTCA

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

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Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496651

Locations


Denmark
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200

Sponsors and Collaborators

Evald Hoej Christiansen

Investigators


Principal Investigator:	Evald H Christiansen, MD	Aarhus University Hospital Skejby

More Information


Responsible Party:	Evald Hoej Christiansen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:	NCT01496651 History of Changes
Other Study ID Numbers:	LeftMain/NOBLE
Study First Received:	December 19, 2011
Last Updated:	January 30, 2015
Health Authority:	Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:


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 September 29, 2016

Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis (LeftMain/NOBLE)