June 14, 2013 — Preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial confirm prior retrospective publications and demonstrate the clinical usefulness of an iFR/fractional flow reserve (FFR) hybrid approach to simplify lesion assessment and to save the use of hyperemic drugs in a significant number of patients. It was also announced that this hybrid iFR/FFR strategy, along with intravascular ultrasound (IVUS) guidance, will be used in the multi-center SYNTAX2 trial in Europe starting later this year.
The ADVISE II findings replicated prior 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 percent of patients participating in the trial, while saving more than 50 percent of such patients from hyperemic drug administration. In fact, the preliminary analysis showed 91.5 percent agreement with FFR and 71.5 percent hyperemic drug savings on a per lesion basis. Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe, and all analysis was performed with operators blinded from the iFR values which were calculated offline at an independent core lab in Rotterdam, Netherlands.
Results from the first 392 real-time cases performed live in the cath lab from more than 20 centers in Europe, Japan and South Africa that are now equipped with the iFR software confirmed the prior results and those of the preliminary ADVISE II findings.
“After using iFR in real world clinical practice, it’s simplicity is clearly its strength. In a busy cath lab, saving time is important and the results in my early experience have been consistent and clinically useful,” commented Andrew Sharp, M.D., interventional cardiologist at Royal Devon and Exeter Hospital, Exeter, United Kingdom. “Once real-world operators have the opportunity to use both of these complementary technologies, I think they will be impressed.”
Volcano and Boston Scientific Corp. will also co-sponsor the investigator-led SYNTAX2 clinical study. SYNTAX2 is designed to test precision guided percutaneous coronary intervention (PCI), 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 are treated. Boston Scientific 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.
For more information: www.volcanocorp.com