NOBLE-LAD: Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.
Study Details
Study Description
Brief Summary
The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.
According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.
The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG
The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.
Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.
Substantiated expectations:
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PCI is superior to bypass operation concerning short-term quality of life.
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Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
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Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
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Outcome may be dependent on lesion complexity, diabetes and gender.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Percutaneous coronary intervention (PCI) Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion. |
Procedure: Percutaneous coronary intervention (PCI)
Revascularization of LAD lesion by PCI
|
| Experimental: Coronary artery bypass grafting (CABG) Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion. |
Procedure: Coronary artery bypass grafting (CABG)
Revascularization of LAD lesion by CABG
|
Outcome Measures
Primary Outcome Measures
- All-cause mortality [10 years]
Death of any cause
- Quality of life [1 year]
By SF 12 and Seatle Angina Questionaire
- MACCE [1 year]
Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)
Secondary Outcome Measures
- All-cause death [1, 2, 3, 5 and 10 years]
Death of any cause
- Cardiac death [1, 2, 3, 5 and 10 years]
Death of cardiac disease
- Spontaneous myocardial infarction [1, 2, 3, 5 and 10 years]
Type 1 myocardial infarction
- Procedure related myocardial infarction [1, 2, 3, 5 and 10 years]
Myocardial infarction related to PCI or CABG
- Major stroke, minor stroke and al stroke [1, 2, 3, 5 and 10 years]
Stroke by VARC definition
- Angina [1, 2, 3, 5 and 10 years]
CCS angina class
- Heart failure [1, 2, 3, 5 and 10 years]
NYHA class
- Stent thrombosis [1, 2, 3, 5 and 10 years]
ARC-define stent thrombosis
Eligibility Criteria
Criteria
Inclusion Criteria:
Heart Team decision on treatment
1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (>90% by visual assessment or FFR <80% The lesion may be treated by both PCI and surgery
Exclusion Criteria:
ST-elevation myocardial infarction within 24 hours. Expected survival <1 year, because of high age or severe cardiac or non-cardiac disease.
Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age < 18 years. Study required information and consent suboptimal or impossible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Denmark | 9100 |
Sponsors and Collaborators
- Aalborg University Hospital
- Oulu University Hospital
- Region Örebro County
- Pauls Stradins Clinical University Hospital
Investigators
- Principal Investigator: Leif Thuesen, MD, Department of Cardiology, Aalborg University Hospital
- Principal Investigator: Jan Jesper Andreasen, Prof, Department of Cardiothoracic Surgery, Aalborg University Hospital
- Study Chair: Peter Sogaard, Prof, Department of Cardiology, aaalborg University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NOBLE-LAD_Protocol version 3