Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.

Study Overview
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Brief Summary
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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

Detailed Description
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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: PCI is superior to bypass operation concerning short-term quality of life. Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality. Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies. Outcome may be dependent on lesion complexity, diabetes and gender.

Official Title
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The Nordic-Baltic Heart Team Initiative for Improved Long-term Coronary Artery Revascularization Outcome in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. NOBLE LAD

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting (CABG)
* Procedure: Percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous coronary intervention (PCI)<br>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)<br>* Revascularization of LAD lesion by PCI<br>|
| Experimental: Coronary artery bypass grafting (CABG)<br>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)<br>* Revascularization of LAD lesion by CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death of any cause | 10 years | 
| Quality of life | By SF 12 and Seatle Angina Questionaire | 1 year | 
| MACCE | Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Death of any cause | 1, 2, 3, 5 and 10 years | 
| Cardiac death | Death of cardiac disease | 1, 2, 3, 5 and 10 years | 
| Spontaneous myocardial infarction | Type 1 myocardial infarction | 1, 2, 3, 5 and 10 years | 
| Procedure related myocardial infarction | Myocardial infarction related to PCI or CABG | 1, 2, 3, 5 and 10 years | 
| Major stroke, minor stroke and al stroke | Stroke by VARC definition | 1, 2, 3, 5 and 10 years | 
| Angina | CCS angina class | 1, 2, 3, 5 and 10 years | 
| Heart failure | NYHA class | 1, 2, 3, 5 and 10 years | 
| Stent thrombosis | ARC-define stent thrombosis | 1, 2, 3, 5 and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary revascularization