Royal Philips (NYSE:PHG) said today it has enrolled more than 5,000 patients in 3 clinical studies examining its Volcano proprietary instant wave-free ratio pressure measurement technology against conventional fractional flow reserve measurements.
Both FFR and iFR measure differences in blood pressure through partially blocked coronary arteries to assess whether blockage is caused by a shortage of oxygen to the heart muscle, Philips said.
Both methods are performed with a guide wire-based pressure sensor inserted into the artery through the patient’s leg, but FFR requires an injection of a hyperemic agent to dilate the artery, Philips said. The iFR method synchronizes pressure measurements to a “wave-free” period in the patient’s heartbeat, the company said.
Philips said the combined 3 studies represent “1 of the largest intra-coronary physiolgoic data sets ever collected,” more than 2 times the size of the combined enrollment of the Defer, Fame and Fame 2 studies.
“The combination of these studies adds to the wealth of already published prospective physiology outcome data and may help expand the adoption of iFR, which is already used in over 3,000 cath labs worldwide. Additionally, the nearly 2,000 patients with ACS significantly add to the evidence on physiologic assessment in this type of condition, and may be able to help physicians determine the most appropriate treatment and improve patient care,” image guided therapy devices segment leader Andrew Tochterman
Of the 3 studies, the Define-Flair and iFR Swedeheart aim to assess differences in patient outcomes at 1 year when guided by both iFR and FFR.
The last trial, the Syntax II, aims to evaluate the relative treatment outcomes of hybrid iFR/FFR strategies in addition to intravascular ultrasound guidance to compare the clinical utility of percutaneous coronary interventions against bypass surgeries for 3-vessel coronary disease.
“We are all really excited about completing enrollment for the Define-Flair, iFR Swedeheart and Syntax II studies. Together, these three major clinical outcome studies will more than double the randomized published physiology data, and have the potential to re-shape revascularization guidelines and help physicians perform PCI procedures more likely to benefit their patients,” Define-Flair study chair and Syntax II steering committee chair Patrick Serruys said in prepared remarks.