Evolving Routine Standards in Intracoronary Physiology (ERIS)

University Hospital of Ferrara

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Other: fractional flow reserve not performed; Device: fractional flow reserve performed

Study type: Observational

Funder types: Other

Identifiers

NCT03082989

110109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,858 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,858 participants in 2 patient groups

fractional flow reserve performed

Description:

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

Treatment:

Device: fractional flow reserve performed

fractional flow reserve not performed

Description:

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

Treatment:

Other: fractional flow reserve not performed