Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome

October 20, 2022 updated by: Uppsala University

Prognostic Impact of Fractional Flow Reserve in Chronic Coronary Syndrome: Quasi-Experimental Findings Using a Regression Discontinuity Design

The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.[1] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention (PCI) in chronic coronary syndrome patients is confirmed in a real-life scenario. This study will implement a regression discontinuity design (RDD). RDD is a quasi-experimental study design able to provide robust findings on causality using observational data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients in this study were included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), a sub-registry of SWEDEHEART. [2] Data regarding FFR assessments are documented in SCAAR in terms of FFR values and coronary segments investigated with FFR. The use of FFR during PCI is left at the discretion of the operator. Since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy RDD design will be used in the analyses. Moreover, FFR values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. Local linear regression estimates with Kernel triangulation and asymmetric bandwidth selection will be used in the analysis. Bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.[3] Estimates from RDD will be presented as risk differences [RD] complemented by 95% robust confidence intervals.[4]

Study Type

Observational

Enrollment (Actual)

5000

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic coronary syndrome undergoing coronary angiography and FFR measurement in Sweden.

Description

Inclusion Criteria:

  • Chronic coronary syndrome undergoing coronary angiography and FFR measurement
  • Swedish personal identification number

Exclusion Criteria:

  • previous coronary artery bypass grafting
  • left main disease or undergoing FFR/PCI of left main
  • IVUS/OCT use
  • diffuse disease (≥ 2 segments treated in a same vessel investigated with FFR, ≥ 2 segments investigated with FFR in a same vessel)
  • PCI in a distal segment with respect to FFR measurements

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FFR below 0.80
Patients with significant coronary hyperemic gradient
Procedure: Coronary revascularization
Coronary revascularization performed by PCI in a vessel investigated with FFR or indication for surgery
FFR above 0.80
Patients without significant coronary hyperemic gradient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI
Time Frame: Up to one year following index FFR measurement
Up to one year following index FFR measurement

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction
Time Frame: Up to one year following index FFR measurement
Up to one year following index FFR measurement
Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction
Time Frame: Up to one year following index FFR measurement
Up to one year following index FFR measurement
Risk differences (%) for the individual components of the composite outcome measures
Time Frame: Up to one year following index FFR measurement
Up to one year following index FFR measurement

Collaborators and Investigators

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

Sponsor

Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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