Clinical trial NCT06281041: Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention
Official title: Antiplatelet Agents in Patients With Intermediate Coronary Artery Stenosis and Negative Fractional Flow Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Keywords: Coronary artery stenosis
Antiplatelet agent
Fractional flow reserve
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Chonnam National University
First posted: 2024-02-28
Enrollment: 4657
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events
timeFrame: at 5 years from index procedure
measure: Gastrointestinal bleeding
timeFrame: at 5 years from index procedure
Secondary outcomes:
measure: All-cause death
timeFrame: at 5 years from index procedure
measure: Myocardial infarction
timeFrame: at 5 years from index procedure
measure: Unplanned revascularization
timeFrame: at 5 years from index procedure
measure: Stroke
timeFrame: at 5 years from index procedure
measure: Major bleeding
timeFrame: at 5 years from index procedure
measure: Gastrointestinal bleeding necessitated hospitalization without documented transfusion
timeFrame: at 5 years from index procedure
measure: Intracranial hemorrhage
timeFrame: at 5 years from index procedure
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Medical School
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Danbee Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References: