The primary objective of this study is to determine whether among symptomatic and asymptomatic carotid artery stenosis (CAS) patients with no known coronary artery disease (CAD) who had undergone carotid artery revascularization (endarterectomy of stenting) a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.
Inform consent obtained before any study-related activities;
Age above or equal to 50 years with symptomatic or asymptomatic critical carotid stenosis (symptomatic patients with at least Rankin III) which has been successfully revascularized by carotid endarterectomy or stenting within the past 14 days;
Willing and able to undergo coronary CTA scan within 14 days of randomization and agrees to submission of CTA data set for HeartFlow FFRct analysis with results made available to treating physician.
Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
Patient underwent coronary angiography or coronary CTA before the randomization;
Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
Patients with symptomatic or asymptomatic carotid artery stenosis (CAS) (symptomatic to asymptomatic in 1:1 ratio) and no prior cardiac history, no myocardial infarction, no coronary angiography or coronary CTA, and no coronary revascularization (PCI or CABG) who have undergone successful carotid artery revascularization with planned post-operative best medical therapy.
Cohort
Prospective
Coronary CT angiography and FFRct analysis
Diagnostic testA new non-invasive cardiac diagnostic test, coronary CT-derived fractional flow reserve (FFRCT) provides a unified anatomic and functional assessment of coronary artery disease which can reliably identify ischemia-producing coronary lesions. FFRCT accurately reflects invasively measured FFR and can help guide patient management and coronary revascularization decisions.
Major Adverse Cardiac Events
A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization
Major Adverse Cardiac Events and survival
Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularization, all-cause death
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