NCT06281041

Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

Antiplatelet Agents in Patients With Intermediate Coronary Artery Stenosis and Negative Fractional Flow Reserve

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,657 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis

Interventions

Type	Name	Description
DRUG	Antiplatelet Agents	Aspirin or clopidogrel

Timeline

• Start date: 2013-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-02-28
• Last updated: 2025-03-14

Locations

1 site across 1 country: South Korea