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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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ClinicalTrials.gov Identifier: NCT01496651
Recruitment Status : Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Percutaneous coronary intervention Procedure: Coronary artery bypass graft operation Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nordic-Baltic-British Left Main Revascularization Study (NOBLE)
Study Start Date : November 2008
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : December 2018

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG) [ Time Frame: After 2 years ]

Secondary Outcome Measures :
  1. Combined endpoint of death, stroke and non-index treatment related MI [ Time Frame: After 1 month and 1, 2, 3, 4 and 5 years ]
  2. 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 ]
  3. New revascularization by CABG or PCI [ Time Frame: After 1, 2 ,3 ,4 and 5 years ]
  4. Death [ Time Frame: After 10 years ]
  5. Definite stent thrombosis/symptomatic graft occlusion [ Time Frame: Index to 5 years ]
  6. CCS angina score [ Time Frame: Index to 5 years ]
  7. NYHA functional class [ Time Frame: Index to 5 years ]
  8. Duration of admission for index treatment [ Time Frame: Index and 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum in: Lancet. 2016 Dec 3;388(10061):2742.

Responsible Party: Evald Hoej Christiansen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01496651     History of Changes
Other Study ID Numbers: LeftMain/NOBLE
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by Evald Hoej Christiansen, 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