Coronary (Artery); Disease Clinical Trial
Official title:
"Long-term Follow-up of Patients With Multivessel Coronary Artery Disease Undergoing CABG - Comparison Between Functional, Anatomical, or Medical Only-Based Evaluation to Prevent Cardiovascular Events - The FAMOUS Trial"
The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. The primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.
Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually
associated with impairment in quality of life, and with a high risk for cardiovascular
events including myocardial infarction and cardiovascular death. Because of the anatomical
and/or functional extension of the disease, combined with high-risk clinical features (left
ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients
must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG
surgeries are performed annually.
Although the benefits of CABG for those high-risk patients have been well established in the
long-term, the best follow-up strategy after surgery is still controversial. Current
guidelines generally recommend that the follow-up of patients after CABG should be based on
the same strategies proposed for patients with stable angina. The investigators hypothesized
that the early identification of myocardial ischemia or progression of coronary
atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone
for the prevention of cardiovascular events.
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