Evolving Routine Standards in Intracoronary Physiology

University Hospital of Ferrara1,858 enrolled

Overview

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.

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

1,858

Conditions

Myocardial Ischemia

Interventions

fractional flow reserve performedDEVICE

assessing fractional flow reserve to drive revascularization

fractional flow reserve not performedOTHER

description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Ferrara

Cona, Ferrara, Italy

Outcomes

Primary Outcomes

agreement with current guidelines

percentage of patients receiving a FFR assessment in agreement with current guidelines

Time frame: intra-procedure

Secondary Outcomes

reasons leading to FFR disuse

description of the main reasons leading operator to prefer not assessment of coronary

Time frame: intra-procedure

Data from ClinicalTrials.gov

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