Volcano Announces Preliminary Results From the ADVISE II Study

May 23, 2013—Volcano Corporation (San Diego, CA) announced preliminary results from the ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation II) trial during the late-breaking clinical trials session at EuroPCR 2013 in Paris, France.

According to Volcano, these prospective results confirm previous retrospective publications and demonstrate the clinical usefulness of a hybrid approach with Volcano's Instant Wave-Free Ratio (iFR) software and fractional flow reserve (FFR) to simplify lesion assessment and to reduce the use of hyperemic drugs in a significant number of patients. The company also announced that this hybrid iFR/FFR strategy— along with intravascular ultrasound (IVUS) guidance—will be used in the multicenter SYNTAX2 trial starting later this year in Europe.

The ADVISE II findings replicated previous iFR retrospective publications, which demonstrated that use of a hybrid iFR/FFR workflow delivered an overall classification agreement with an FFR in more than 90% of patients participating in the trial, while preventing more than 50% of such patients from undergoing hyperemic drug administration. The preliminary analysis showed 91.5% agreement with FFR and 71.5% hyperemic drug savings on a per lesion basis, noted the company.

Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe. All analyses were performed with operators blinded from the iFR values, which were calculated offline at an independent core lab in Rotterdam, The Netherlands.

“An important step in the validation of any new technology is to identify a hypothesis based on observations and to then prospectively test the hypothesis in a large number of centers to see if the observations translate to real-world practice,” commented Javier Escaned, MD, in Volcano's press release. Dr. Escaned, who is an interventional cardiologist at Hospital Clínico San Carlos in Madrid, Spain, continued, “The ADVISE II study is the first prospective test of the true iFR algorithm that is analyzed through an independent physiology core lab—Cardialysis, Rotterdam, Netherlands. These preliminary results show that the prior observations can be replicated prospectively and that a hybrid iFR/FFR approach can provide a > 90% agreement with FFR while saving the use of hyperemic agent in more than half of patients.”

Also at EuroPCR 2013, Volcano announced the investigator-led SYNTAX2 trial, which will be cosponsored by Volcano and Boston Scientific Corporation (Natick, MA). SYNTAX2 is designed to test precision-guided percutaneous coronary intervention, using a clinical SYNTAX score as derived at Cardialysis in Rotterdam along with live iFR/FFR hybrid measurements of the vessel to determine which patients and lesions to treat. Boston Scientific's Synergy drug-eluting stents will then be placed with IVUS guidance, using both Volcano and Boston Scientific IVUS devices, to provide more accurate stent placement than has been demonstrated with angiography alone.