Coronary Artery Disease, Coronary Artery Stenosis
Conditions
Keywords
Coronary artery stenosis, Antiplatelet agent, Fractional flow reserve, Prognosis
Brief summary
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).
Detailed description
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.
Interventions
Aspirin or clopidogrel
Sponsors
Chonnam National University
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm * Patients who underwent invasive coronary angiography and FFR measurement * Patients whose revascularization was deferred based on FFR\>0.80
Exclusion criteria
* Patients who underween FFR measurement after expansion of reimbursement criteria of FFR (since 2021) * Patients with history of any bleeding with blood transfusion * Patients with use of non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin * Patients with previous atherosclerotic cardiovascular disease * Patients with already on antiplatelet agents including dual antiplatelet agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | at 5 years from index procedure | Primaey efficacy ouotcome (MACCE, a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke) |
| Gastrointestinal bleeding | at 5 years from index procedure | Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned revascularization | at 5 years from index procedure | Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index hospitalization |
| Stroke | at 5 years from index procedure | 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. |
| All-cause death | at 5 years from index procedure | All-cause death which was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea. |
| Gastrointestinal bleeding necessitated hospitalization without documented transfusion | at 5 years from index procedure | Gastrointestinal bleeding necessitated hospitalization without documented transfusion |
| Intracranial hemorrhage | at 5 years from index procedure | Intracranial hemorrhage |
| Major bleeding | at 5 years from index procedure | Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion. |
| Myocardial infarction | at 5 years from index procedure | Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization |
Countries
South Korea
Outcome results
None listed