Veiligheid en effectiviteit van PCI optimalisatie door het gebruik van hoge resolutie IVUS vergeleken met de standaard behandeling bij patiënten met een lage FFR na de procedure

Fractional flow reserve (FFR) after a percutaneous coronary intervention (PCI) proved to be a strong and independent predictor of Major Adverse Cardiac Events (MACE). A number of factors can cause a post PCI pressure drop over a treated segment which can be revealed by intravascular ultrasound (IVUS). It is currently unknown if optimization of impaired post PCI FFR with IVUS might improve patient outcome.

The objective of the FFR-REACT trial is to assess if FFR guided PCI optimization directed by High Definition (HD)-IVUS in patients with a post-PCI FFR below 0.90 will improve target vessel failure. In this prospective trial 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or IVUS-directed optimization to a FFR ≥ 0.90 (treatment arm). Assuming that 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Post PCI FFR measurements will be performed in all patients. The total follow-up period for all patients will be 3 years.

The primary study end point is defined as target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven TVR at 1 year.

This study will provide novel insights for a potentially new patient group where post PCI FFR is followed by IVUS to optimize therapy.

Patients will be followed-up at 6 months, 1, 2 and 3 years post PCI

FFR-guided optimization directed by the ACIST HDi® IVUS System using the Kodama® IVUS catheter will be performed in the treatment arm. Patients will be followed for up to 3 years.