Coronary Artery Disease
Conditions
Keywords
Coronary revascularization
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.
Interventions
Revascularization of LAD lesion by CABG
PROCEDUREPercutaneous coronary intervention (PCI)
Revascularization of LAD lesion by PCI
Sponsors
Oulu University Hospital
Region Örebro County
Pauls Stradins Clinical University Hospital
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical outcomes will be assessed by an independent event committee with no knowledge of treatment allocation.
Intervention model description
1:1 randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| All-cause death | 1, 2, 3, 5 and 10 years | Death of any cause |
| Heart failure | 1, 2, 3, 5 and 10 years | NYHA class |
| Stent thrombosis | 1, 2, 3, 5 and 10 years | ARC-define stent thrombosis |
| Angina | 1, 2, 3, 5 and 10 years | CCS angina class |
| 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 |
Countries
Denmark
Outcome results
None listed