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Impossible to involve a sufficient number of centers in the study.
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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Region Örebro County | OTHER |
| Pauls Stradins Clinical University Hospital | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Active Comparator | Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion. |
|
| Coronary artery bypass grafting (CABG) | Experimental | Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery bypass grafting (CABG) | Procedure | Revascularization of LAD lesion by CABG |
|
| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Leif Thuesen, MD | Department of Cardiology, Aalborg University Hospital | Principal Investigator |
| Jan Jesper Andreasen, Prof | Department of Cardiothoracic Surgery, Aalborg University Hospital | Principal Investigator |
| Peter Sogaard, Prof | Department of Cardiology, aaalborg University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9100 | Denmark |
After publication of the trial, data will be made available for metaanalyses on request, and after accept by the steering committee.
Study protocol and statistical analysis plan available by now.
At clinicaltrial.gov
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1:1 randomized clinical trial
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The clinical outcomes will be assessed by an independent event committee with no knowledge of treatment allocation.
| Percutaneous coronary intervention (PCI) | Procedure | Revascularization of LAD lesion by PCI |
|
| 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 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D057510 | Endovascular Procedures |
| D019060 | Minimally Invasive Surgical Procedures |
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