Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair (EVAR_DAPT_SAPT)

A Target Trial Emulation for Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair

This study was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included.

Study Overview

• Status: Completed
• Conditions: Endovascular Aneurysm Repair (EVAR); Abdominal Aortic Aneurysms (AAA)

Detailed Description

Among these patients, any patients who were prescribed SAPT or DAPT at the date of discharge from the index hospitalization for standard EVAR were defined as being in the SAPT group (N=4,162) and the DAPT group (N=4,163), respectively.

• Study Type: Observational
• Enrollment (Actual): 8325

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent EVAR for AAA and were successfully discharged and prescribe any antiplatelet therapy.

Description

Inclusion Criteria:

• All patients who underwent EVAR for AAA and were successfully discharged

Exclusion Criteria:

• Patients who had experienced a myocardial infarction
• Patients who had experienced a stroke
• Patients who had experienced percutaneous coronary intervention
• Patients who had history of peripheral disease
• Patients who had major bleeding event within 1 year of admission
• Those prescribed non-vitamin K antagonist oral anticoagulant or warfarin
• Patients who did not prescribe any antiplatelet therapy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Dual antiplatelet therapy; Patients who were prescribed dual antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR
Single antiplatelet therapy; Patients who were prescribed single antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)	composite of all-cause death, myocardial infarction (MI), or ischemic stroke	1 year after EVAR
Major or clinically relevant non-major bleeding	Diagnostic codes in the primary or secondary position and transfusion receipt	1 year after EVAR
Re-intervention or surgery for AAAs	Re-intervention or surgery for AAAs	1 year after EVAR

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dual antiplatelet therapy; Endovascular Aneurysm Repair (EVAR); Single antiplatelet therapy; Abdominal Aortic Aneurysms (AAA)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: Antiplatelet After EVAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No