Evolving Routine Standards in Intracoronary Physiology (ERIS)

Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Device: fractional flow reserve performed; Other: fractional flow reserve not performed

Detailed Description

Fractional flow reserve (FFR) has been validated as a reliable surrogate for inducible ischemia, supporting its use during invasive procedures for functional assessment of coronary lesions. Landmark randomized trials have demonstrated that deferral of nonsignificant lesions based on FFR is not only safe, but also that FFR-guided revascularization is associated with a better clinical outcome up to 2 years, when compared with standard angiography.

In spite of the overwhelming evidence of its potential clinical and economic benefits and strong guideline recommendation, the adoption of FFR in the real-world is perceived to vary significantly. Reasons for this disparity are several, but most operators still do rely the most on angiographic eye-balling to decide on the functional significance of coronary lesions and the need for revascularization.

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

• Study Type: Observational
• Enrollment (Actual): 1858

Contacts and Locations

Study Locations

• Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography

Description

Inclusion Criteria:

FRACTIONAL FLOW RESERVE PERFORMED GROUP

• age >18 years
• written consent
• assessment with FFR of at least one coronary lesion

FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP

• age >18 years
• written consent

• absence of assessment with FFR of at least one coronary lesion

  + at least one of the following criteria

  1. stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)
  2. stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)

  3. acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis)

     Exclusion Criteria:

• written consent denied

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fractional flow reserve performed; consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography where the operator decided to use fractional flow reserve to drive the revascularization	Device: fractional flow reserve performed; assessing fractional flow reserve to drive revascularization
fractional flow reserve not performed; consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography and satisfying prespecified criteria where the operator decided to not use fractional flow reserve to drive the revascularization	Other: fractional flow reserve not performed; description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
agreement with current guidelines	percentage of patients receiving a FFR assessment in agreement with current guidelines	intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reasons leading to FFR disuse	description of the main reasons leading operator to prefer not assessment of coronary	intra-procedure

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Collaborators: Società Italiana di Cardiologia Invasiva
• Investigators: Principal Investigator: Marco Luciano Rossi, MD, Humanitas, Rozzano (MI); Principal Investigator: Giulio Stefanino, MD, Humanitas, Rozzano (MI); Principal Investigator: Matteo Tebaldi, MD, AOU Ferrara; Principal Investigator: Gianluca Campo, MD, AOU Ferrara; Principal Investigator: Massimo Fineschi, MD, AOU Siena; Principal Investigator: Giuseppe Musumeci, MD, AOU Cuneo

Publications and helpful links

General Publications

• Tebaldi M, Biscaglia S, Fineschi M, Musumeci G, Marchese A, Leone AM, Rossi ML, Stefanini G, Maione A, Menozzi A, Tarantino F, Lodolini V, Gallo F, Barbato E, Tarantini G, Campo G. Evolving Routine Standards in Invasive Hemodynamic Assessment of Coronary Stenosis: The Nationwide Italian SICI-GISE Cross-Sectional ERIS Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1482-1491. doi: 10.1016/j.jcin.2018.04.037. Epub 2018 May 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 110109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No