angina pectoris coronary artery disease
Conditions
Interventions
Two treatment strategies:
Group 1: Cardiac surgery (bypass grafting of the left anterior descending [LAD]
coronary artery) and percutaneous coronary intervention of any other severe
stenosis of the
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Stable coronary artery disease OR Hemodynamically stable patients with a Non-STE Acute Coronary Syndrome AND Hemodynamically significant LAD disease, as assessed by fractional flow reserve (FFR, 90% lesion; OR 0.8). Please be aware that in the case of a diffusely diseased LAD and randomisation for the percutaneous arm, optimal medical therapy is seen as LAD-revascularization. The local Heart Team must conclude that: The LAD, irrespective of focal or diffuse disease, is suitable for both LIMA-LAD grafting and PCI (in the case of focal LAD disease). Focally diseased LADs are suitable for PCI. In the case of multivessel disease (2VD or 3VD) CABG not better than one of the study related treatments (for a medical reason e.g. porcelain aorta, poor conduits, comorbidities, frailty etc.). All NON-LAD lesions and coronary arteries must be suitable for FFR guided percutaneous coronary intervention. Age >= 18 and
Exclusion criteria
Exclusion criteria: Previous CABG Any target lesion with in-stent restenosis within 1 year Significant Left Main involvement Significant valvular heart disease Prior anterior myocardial infarction with clear evidence of residual akinesia and/or dyskinesia Extremely calcified or tortuous vessels precluding LAD FFR measurement or OCT of the LAD. Planned major surgery within the next 12 months Extra-cardiac illness that is expected to limit survival to less than 1 years Allergy or hypersensitivity to any of the study related drugs or devices (e.g. metals, antithrombotic agent etc.) Active participation in another randomized trial Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator Pregnant at the time of screening or unwilling to use effective birth control measures while dual antiplatelet therapy is required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: MACE: cardiovascular mortality, myocardial infarction (MI), stroke, unplanned revascularisation after the index procedure, or hospitalisation (>24 hours) due to cardiac ischaemia after the index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Angina status, physical limitations and quality of life (measured by the SAQ summary score). | — |
Countries
Netherlands
Outcome results
None listed