Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome

NCT05592535 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Coronary Syndrome

Keywords

Percutaneous Coronary Intervention; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI

  Up to one year following index FFR measurement

Secondary Outcomes (3)

• Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction

  Up to one year following index FFR measurement

• Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction

  Up to one year following index FFR measurement

• Risk differences (%) for the individual components of the composite outcome measures

  Up to one year following index FFR measurement

Study Arms (2)

FFR below 0.80

Patients with significant coronary hyperemic gradient

Procedure: Coronary revascularization

FFR above 0.80

Patients without significant coronary hyperemic gradient

Interventions

Coronary revascularization PROCEDURE

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

FFR below 0.80

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Related Publications (4)

• De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

  PMID: 22924638 BACKGROUND

• Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27.

  PMID: 20801780 BACKGROUND

• Calonico S, Cattaneo MD, Farrell MH. Optimal bandwidth choice for robust bias corrected inference in regression discontinuity designs. Econom J. 2020;23(2):192-210.

  BACKGROUND

• Calonico S, Cattaneo MD, Titiunik R. Robust nonparametric confidence intervals for regression-discontinuity designs. Econometrica. 2014;82(6):2295-2326.

  BACKGROUND

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 24, 2022
• Study Start: June 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share