Volcano Corporation announced final results of ADVISE (Adenosine vasodilator independent stenosis evaluation) II, a prospective, double-blind, global, multicentre registry designed to investigate the diagnostic utility of the Instant Wave-Free Ratio (iFR) Modality in assessing the severity of coronary stenosis.
These final results replicate earlier findings and show that the hybrid iFR/FFR (Fractional Flow Reserve) approach correctly matched an FFR-only approach in 94.2% of coronary stenoses and successfully avoided use of adenosine in 65.1% of patients.
“I believe that the more physiology we can use to guide our patient therapy, the better,” says Amir Lerman, co-principal investigator of ADVISE II and professor of medicine at the Mayo Clinic in Rochester, USA. “Study data has suggested that FFR is associated with improved patient outcomes when used to help decide whether coronary vessels with stenosis require revascularisation with stents or other treatment strategies. However, its use in clinical practice remains low, partly due to the requirement for adenosine administration. For this reason, I believe that the development and potential availability of iFR as an adenosine-free partner to FFR can be a significant development in the field of coronary physiology.”
He adds, “ADVISE II is the first prospective study with scientifically rigorous methodology to investigate the diagnostic utility of iFR in assessing coronary stenosis relevance in patients who represent a real-world population, providing evidence for the clinical value of the hybrid iFR/FFR approach. These results may help solve what I perceive as the underutilisation of physiology in the cath lab. I believe that iFR is worth considering given that the ADVISE II data have shown a 94.2% match with FFR and removed the need for hyperemic drugs in 65.1% of cases.”
The hybrid iFR/FFR approach is possible with the Volcano system because both measurements take place on the same pressure guide wire. In the hybrid workflow, iFR measurement is generally made in seconds after positioning the standard Volcano pressure guidewire.
The iFR modality is currently approved for use in Japan, CE marked. iFR is not commercially available in the USA and is 510(k) pending.