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

February 13, 2022 updated by: Jamshed Ali, Aga Khan University Hospital, Pakistan

Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population

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.

Study Overview

Status

Completed

Conditions

Coronary Artery Disease

Intervention / Treatment

Diagnostic test: Fractional flow reserve, instantaneous wave-free Ratio

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 Type

Observational

Enrollment (Actual)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Pakistan
- Sindh
  - Karachi, Sindh, Pakistan
    - Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mean age of study population was 62 ±11 years and majority (71%) of the population was male.76% (263) of the population was hypertensive, diabetes mellitus and dyslipidemia was present in 49%(169) and 53%(185) respectively. History of myocardial infarction (MI) was present in 12% (43) and one-fourth of population had history of revascularization, i.e PCI (19%) or coronary artery bypass grafting(CABG) 3%.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death Time Frame: 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	29 months
Non-fatal myocardial infarction Time Frame: 29 months	Number of patients suffering from Myocardial infarction but did not die.	29 months
Target vessel revascularization. Time Frame: 29 months	Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI	29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

August 20, 2021

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)