Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chonnam National University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiplatelet agents | Among patients with intermediate coronary artery stenosis (50-70% diameter stenosis by quantitative coronary angiography) but who did not undergo PCI based on negative FFR, those who were taking antiplatelet agents (aspirin or clopidogrel) are classified into this group. |
| |
| No antiplatelet agents | Among patients with intermediate coronary artery stenosis (50-70% diameter stenosis by quantitative coronary angiography) but who did not undergo PCI based on negative FFR, those who were not taking antiplatelet agents (aspirin or clopidogrel) are classified into this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiplatelet Agents | Drug | Aspirin or clopidogrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | Primaey efficacy ouotcome (MACCE, a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke) | at 5 years from index procedure |
| Gastrointestinal bleeding | Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion) | at 5 years from index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 5 years from index procedure |
| Myocardial infarction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
From 2013 to 2020, the use of FFR has been reimbursed by insurance criteria for patients with 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm in the absence of prior evidence of inducible myocardial ischemia by non-invasive tests. The current study included participants who underwent FFR but did not receive revascularization, meaning that they had 50-70% intermediate stenosis and revascularization was deferred based on negative FFR between 2013 and 2020.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joo Myung Lee, MD, MPH, PhD | Samsung Medical Center | Principal Investigator |
| Danbee Kang, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Medical School | Gwangju | South Korea |
This is National Helath Insurance Data Analysis. therefore, sharing the original patient-level data is not possible under regulation by Korean Govenment.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010975 | Platelet Aggregation Inhibitors |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization
| at 5 years from index procedure |
| Unplanned revascularization | Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index hospitalization | 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. | at 5 years from index procedure |
| Major bleeding | Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion. | at 5 years from index procedure |
| Gastrointestinal bleeding necessitated hospitalization without documented transfusion | Gastrointestinal bleeding necessitated hospitalization without documented transfusion | at 5 years from index procedure |
| Intracranial hemorrhage | Intracranial hemorrhage | at 5 years from index procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012459 |
| Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |