Rationale and design of the iCORONARY trial: improving the cost-effectiveness of coronary artery disease diagnosis

Area of Science:

• Cardiology
• Medical Imaging
• Interventional Cardiology

Background:

• Revascularization decisions in stable coronary artery disease (CAD) traditionally rely on invasive coronary angiography (ICA) visual stenosis grading.
• Invasive fractional flow reserve (FFR) is the gold standard for assessing the hemodynamic significance of coronary stenosis.
• Emerging non-invasive techniques like computed-tomography-derived FFR (FFR-CT) and angiography-derived FFR (QFR) integrate anatomical and functional data to calculate FFR.

Purpose of the Study:

• To evaluate the non-inferiority of FFR-CT and QFR-guided strategies compared to the standard of care for revascularization decisions in stable CAD patients.
• To assess the costs, effects, and outcomes of different diagnostic strategies in patients with stable angina pectoris undergoing coronary computed tomography angiography.
• To determine if FFR-CT and QFR are viable, less-invasive alternatives to current diagnostic pathways.

Main Methods:

• The iCORONARY trial is a prospective, multicenter, non-inferiority randomized controlled trial (RCT) with blinded endpoint evaluation.
• Patients with stable angina and intermediate coronary stenoses (CAD-RADS 3 or 4A) are randomized into three arms: FFR-CT-guided, QFR-guided, or standard of care (ICA with invasive pressure measurements).
• The primary endpoint is the occurrence of major adverse cardiac events (death, myocardial infarction, repeat revascularization) at one year.

Main Results:

• The study is registered under NCT04939207.
• Results are pending as the trial is ongoing.

Conclusions:

• The iCORONARY trial will determine if FFR-CT or QFR strategies are non-inferior to invasive angiography in guiding revascularization for stable CAD.
• Demonstrating non-inferiority would establish FFR-CT and QFR as attractive, less-invasive alternatives to current diagnostic methods.