Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Percutaneous coronary intervention (PCI)Procedure: Coronary artery bypass grafting (CABG)
- Registration Number
- NCT03538886
- Lead Sponsor
- Aalborg University Hospital
- 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
- 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:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Percutaneous coronary intervention (PCI) 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. Coronary artery bypass grafting (CABG) 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Aalborg University Hospital
🇩🇰Aalborg, Denmark