Skip to content

Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05592535
Enrollment
5000
Registered
2022-10-24
Start date
2015-06-01
Completion date
2020-06-01
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome

Keywords

Percutaneous Coronary Intervention, Fractional Flow Reserve

Brief summary

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.

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.\[4\]

Interventions

Coronary revascularization performed by PCI in a vessel investigated with FFR or indication for surgery

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCIUp to one year following index FFR measurement

Secondary

MeasureTime frame
Risk differences (%) for the individual components of the composite outcome measuresUp to one year following index FFR measurement
Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarctionUp to one year following index FFR measurement
Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarctionUp to one year following index FFR measurement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026