Evolving Routine Standards in Invasive Hemodynamic Assessment of Coronary Stenosis: The Nationwide Italian SICI-GISE Cross-Sectional ERIS Study

Abstract

Objectives: The aims of the ERIS (Evolving Routine Standards of FFR Use) study are to describe the current use of invasive coronary physiology assessment and discern the reasons for its nonuse in daily practice.

Background: Adoption of coronary physiology guidance in the catheterization laboratory varies among countries, centers, and operators.

Methods: ERIS is an investigator-driven, nationwide, prospective, cross-sectional study involving 76 Italian catheterization laboratories. Each center had a 60-day window to include consecutive cases that fulfilled the inclusion and exclusion criteria. Two pre-specified groups were enrolled: 1) patients who had operators apply fractional flow reserve or instantaneous wave-free ratio assessment (physiology assessment group); and 2) patients who had operators decide not to perform fractional flow reserve or instantaneous wave-free ratio assessment, although the patients met the inclusion and exclusion criteria (visual estimation group).

Results: Overall, 1,858 cases were included (physiology assessment group, n = 1,177; visual estimation group, n = 681). Physiology-based guidance was used in 7% and 13% of the total volume of angiographic and percutaneous coronary interventions, respectively. Its use was in line with European and American guidelines in 48% of the cases (n = 569). Physiology guidance was used in a consistent number of patients with acute coronary syndromes (n = 529 [45%]). The main reason for not using physiology guidance was the operator's confidence that clinical and angiographic data alone were sufficient.

Conclusions: Use of coronary physiology assessment in daily practice meets the current guideline indications in approximately 50% of cases. The major limiting factor for the adoption of physiology guidance was the operator's confidence in visual assessment alone. (Evolving Routine Standards of FFR Use [ERIS]; NCT03082989).

Keywords: acute coronary syndrome(s); fractional flow reserve; instantaneous wave-free ratio; percutaneous coronary intervention; stable coronary artery disease.