Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention (NHIS)

Samsung Medical Center

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Treatments: Drug: Antiplatelet Agents

Study type: Observational

Funder types: Other

Identifiers

NCT06281041

NHIS20240220

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,657 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

4,657 participants in 2 patient groups

Antiplatelet agents

Description:

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.

Treatment:

Drug: Antiplatelet Agents

No antiplatelet agents

Description:

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.