There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR). Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR\>0.80).
This study was nationwide cohort study conducted using Korean National Health Insurance Service database. From 2013 to 2020, reimbursement criteria of FFR were patients with no previous evidence of myocardial ischemia and intermediate coronary artery stenosis (50-70%). Patients who were evaluated by coronary angiography and FFR but did not undergo revascularization were selected and classified according to the use of antiplatelet agents after index procedure. Patients with previous history of atherosclerotic cardiovascular disease were excluded. Eligible patients were matched using propensity score in a 1:1 ratio. Primary efficacy outcome was major adverse cardiac and cerebrovascular events a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke at 5-year. Primary safety outcome was gastrointestinal bleeding, regardless of the need of transfusion.
Study Type
OBSERVATIONAL
Enrollment
4,657
Aspirin or clopidogrel
Chonnam National University Medical School
Gwangju, South Korea
Major adverse cardiac and cerebrovascular events
Primaey efficacy ouotcome (MACCE, a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke)
Time frame: at 5 years from index procedure
Gastrointestinal bleeding
Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion)
Time frame: at 5 years from index procedure
All-cause death
All-cause death which was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea.
Time frame: at 5 years from index procedure
Myocardial infarction
Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization
Time frame: at 5 years from index procedure
Unplanned revascularization
Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index hospitalization
Time frame: at 5 years from index procedure
Stroke
Stroke is defined as ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes of diagnostic brain imaging.
Time frame: at 5 years from index procedure
Major bleeding
Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion.
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Time frame: at 5 years from index procedure
Gastrointestinal bleeding necessitated hospitalization without documented transfusion
Gastrointestinal bleeding necessitated hospitalization without documented transfusion
Time frame: at 5 years from index procedure
Intracranial hemorrhage
Intracranial hemorrhage
Time frame: at 5 years from index procedure