Stable Angina Clinical Trial
Official title:
FUnctional Testing Underlying Coronary REvascularisation.
The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2
therapeutic strategies, one based on coronary angiography guidance and the other based on
coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery
disease patients.
The trial is a prospective, multicenter, French, randomized clinical trial including men and
women ≥ 18 years presenting with significant multivessel disease defined by coronary
angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic
vessels. The patients who give their informed consent will be randomly assigned to a
therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the
FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this
multivessel evaluation (angiography or FFR), the investigator will choose the best
therapeutic strategy to his discretion (medical optimal treatment, coronary stenting,
coronary artery bypass graft surgery). The aim of revascularization procedures will be to
obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be
treated.
The primary end point of the trial is a composite of major cardiovascular events including
death from any cause, myocardial infarction, any hospitalization for coronary
revascularization performed in addition to initial treatment and stroke at 1 year of
follow-up.
Secondary end points will include adverse events, individual major cardiovascular events,
stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's
quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.
n/a
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