Nordic-Baltic-British left main revascularisation study

Nordic-Baltic-British left main revascularisation study: coronary artery bypass grafting versus drug eluting stent percutaneous coronary angioplasty in the treatment of unprotected left main stenosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87206264

Enrollment

1200

Registered

2010-05-21

Start date

2009-01-19

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular

Interventions

1. Coronary artery bypass surgery 2. Percutaneous coronary angioplasty with drug eluting stent Follow up length: 60 months Study entry: single randomisation only Contact details for patient informat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stable, unstable angina pectoris or acute coronary syndrome (ACS) 2. Significant lesion* of left main coronary artery (LMCA) ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex** percutaneous coronary intervention (PCI) lesions 3. Patient eligible to be treated by coronary artery bypass graft (CABG) and by PCI 4. Signed informed consent *Visually assessed diameter stenosis greater than 50% or fractional flow reserve less than 0.80 **Length less than 25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion

Exclusion criteria

Exclusion criteria: 1. ST-elevation infarction within 24 hours 2. CABG clearly better treatment option (LMCA stenosis and greater than 3, or complex** additional coronary lesions) 3. Patient is in too high risk for CABG 4. Expected survival less than 1 year 5. Allergy to aspirin, clopidogrel or ticlopidine 6. Allergy to Biolimus **Length greater than 25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion

Design outcomes

Primary

Measure	Time frame
1. Combined endpoint of death, stroke, non-index treatment related myocardioal infarction (MI) and new revascularisation (PCI or CABG) after 2 years 2. Death after 5 years	—

Secondary

Measure	Time frame
1. Combined endpoint of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3 and 4 years 2. Individual endpoints of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3, 4 and 5 years 3. New revascularisation by CABG or PCI after 1, 2, 3, 4 and 5 years 4. Death after 10 years 5. Definite stent thrombosis/symptomatic graft occlusion 6. Canadian Cardiovascular Society (CCS) angina score 7. New York Heart Association (NYHA) functional class 8. Duration of admission for index treatment	—

Measure

Time frame

1. Combined endpoint of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3 and 4 years 2. Individual endpoints of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3, 4 and 5 years 3. New revascularisation by CABG or PCI after 1, 2, 3, 4 and 5 years 4. Death after 10 years 5. Definite stent thrombosis/symptomatic graft occlusion 6. Canadian Cardiovascular Society (CCS) angina score 7. New York Heart Association (NYHA) functional class 8. Duration of admission for index treatment

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Countries

Denmark, Finland, Norway, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026