Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Stenosis
• Interventions: Drug: Antiplatelet Agents

• Registration Number: NCT06281041
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4657

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiplatelet agents	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
Major bleeding	at 5 years from index procedure	Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion.
Intracranial hemorrhage	at 5 years from index procedure	Intracranial hemorrhage

Trial Locations

Locations (1)

Chonnam National University Medical School; 🇰🇷 Gwangju, Korea, Republic of