Final ADVISE II Results Presented for Volcano's iFR Modality

October 30, 2013—Volcano Corporation (San Diego, CA) announced final results from the ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation II) trial. ADVISE II is a prospective, double-blind, global, multicenter registry designed to investigate the diagnostic utility of the Volcano's instant wave-Free Ratio (iFR) modality in assessing the severity of coronary stenosis. The data were presented in a late-breaking trials session at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

The company stated that these final results replicate earlier findings and show that the hybrid iFR/fractional flow reserve (FFR) approach correctly matched an FFR-only approach in 94.2% of coronary stenoses and successfully avoided use of adenosine in 65.1% of patients.

In the company's press release, ADVISE II's Coprincipal Investigator Amir Lerman, MD, commented, “I believe that the more physiology we can use to guide our patient therapy, the better. Study data has suggested that FFR is associated with improved patient outcomes when used to help decide whether coronary vessels with stenosis require revascularization 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.”

Dr. Lerman, who is professor of medicine at the Mayo Clinic in Rochester, Minnesota, added, “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 underutilization 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.”

According to the company, the hybrid iFR/FFR approach with the Volcano system allows both measurements to be taken on the same pressure guidewire. 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, and in markets that recognize European CE-Mark approval. In the United States, iFR is not commercially available and US Food and Drug Administration 510(k) clearance is pending.

The company noted that proper documentation and appropriate use criteria are helping to standardize treatment patterns in clinical practice but that interpretation of angiographic images is inherently subjective. Tools such as iFR and FFR provide an objective measure. The ADVISE II results show that the retrospective performance of the iFR algorithm has been confirmed in a controlled, prospective manner at 40 global centers with many different users.