Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05240768
• Lead Sponsor: Aga Khan University Hospital, Pakistan

Brief Summary

The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Detailed Description

Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration.

This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR.

Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Study Timeline

• Study Start: 2020-01-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-20
• Study First Submitted: 2021-11-03
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-13
• Last Update Submitted: 2022-02-13
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Patients who had intermediate to severe coronary lesions on coronary angiogram.
• Patients who had negative FFR >0.80 or iFR >0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.

Exclusion Criteria

• Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
• Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac death	29 months	Number of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock
Target vessel revascularization.	29 months	Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI
Non-fatal myocardial infarction	29 months	Number of patients suffering from Myocardial infarction but did not die.

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan