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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4
Revascularization of LAD lesion by CABG
Revascularization of LAD lesion by PCI
Aalborg University Hospital
Aalborg, Denmark
All-cause mortality
Death of any cause
Time frame: 10 years
Quality of life
By SF 12 and Seatle Angina Questionaire
Time frame: 1 year
MACCE
Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)
Time frame: 1 year
All-cause death
Death of any cause
Time frame: 1, 2, 3, 5 and 10 years
Cardiac death
Death of cardiac disease
Time frame: 1, 2, 3, 5 and 10 years
Spontaneous myocardial infarction
Type 1 myocardial infarction
Time frame: 1, 2, 3, 5 and 10 years
Procedure related myocardial infarction
Myocardial infarction related to PCI or CABG
Time frame: 1, 2, 3, 5 and 10 years
Major stroke, minor stroke and al stroke
Stroke by VARC definition
Time frame: 1, 2, 3, 5 and 10 years
Angina
CCS angina class
Time frame: 1, 2, 3, 5 and 10 years
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Heart failure
NYHA class
Time frame: 1, 2, 3, 5 and 10 years
Stent thrombosis
ARC-define stent thrombosis
Time frame: 1, 2, 3, 5 and 10 years