SAN FRANCISCO, Sept. 24 /PRNewswire-FirstCall/ -- Volcano Corporation , a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, announced today imaging results from PROSPECT, the landmark 700 patient natural history study sponsored by Abbott and co-funded by Volcano. These data demonstrate the progression of cardiovascular disease via precise, intravascular imaging, and the ability of Volcano's proprietary VH(R) IVUS technology to be used to classify lesions by plaque "type" per the PROSPECT protocol and to assess the risk of each plaque type to cause an event, or to remain stable out to three years. PROSPECT results presented today include the landmark finding that angiographically mild lesions with certain morphologic features on grayscale and VH IVUS present with a 3 year cardiac event rate of 17%, versus other morphologies (indistinguishable by conventional angiograms) with three year event risks of less than 1%.
"For years, interventional cardiologists have been focused on using angiography to identify blockages and to restore flow. PROSPECT teaches us that looking at the angiographic severity of the blockage is not enough, and we must understand the type of disease present in the vessel wall," said Gregg Stone, MD, of Columbia University Medical Center and Principal Investigator of PROSPECT. "With VH(R) IVUS we can clearly see two things: one, that "mild" lesions on angiography are capable of progressing quickly into events for the patient: and two, events also take place in locations of severe disease that are often missed by angiography. Understanding the risk of each lesion type is paramount to minimizing the occurrence of these future events. Current practice using angiography guidance alone is insufficient in that regard."
"Angiography alone is not enough and more and more clinical data continues to support that conclusion," said Scott Huennekens, President and CEO of Volcano. "PROSPECT has shown that not all coronary disease is the same. We cannot predict a patient's risk of having future cardiac events by looking at a 2-D, black-and-white image of the arterial lumen. Available tools like IVUS and VH(R) IVUS that look at the quantity, location and type of disease and not just the narrowing of the vessel improve our ability to determine the likelihood of a particular lesion type to cause an event. PROSPECT has shown the ability to use VH and grayscale IVUS to classify different lesion types per the PROSPECT definitions. This trial highlights not only the potential of Volcano's VH(R) IVUS, but just as important, the limitations of using angiography alone."
PROSPECT Results
The PROSPECT event data presented today demonstrates that the measurements made using grayscale and VH(R) IVUS did have a statistically significant impact in determining the likelihood of a particular lesion type to cause an event. The highest risk PROSPECT plaque type being VH Thin Cap Fibroatheromas with a minimum lumen area of less than or equal to 4mm(2) and a plaque burden greater than or equal to 70%. All three of these important parameters (each an independent predictor) when combined showed that the particular lesion imaged at baseline had a 17.2% chance of causing an event within three years. It is important to note that current practice of using angiography alone cannot measure plaque burden or the presence of VH-TCFAs, which were the two most significant predictors of lesion risk in the study. These measures can only be collected using Volcano's proprietary Eagle Eye Gold IVUS catheter not only visualizes and measures plaque burden but also collects signals for VH imaging allowing display of four plaque components.
It is widely believed that a hazard ratio of greater than 2.0 is a clinically meaningful predictor of an event. You can see from the chart below that the hazard ratio for a PROSPECT defined VH-TCFA is 3.8 with a p-value of < 0.0001 indicating a positive predictive value of causing an event that is statistically significant. The converse is true for PIT lesions which have a hazard ratio of only 0.2, indicating low likelihood of causing an event, which is also statistically significant.
Evening Symposium
To explore the imaging data in greater detail, Volcano will host an evening symposium entitled, "Imaging Matters! Identifying high risk patients and optimizing PCI." The symposium will include late breaking results from PROSPECT, FAME and other clinical studies. The first session of the symposium, entitled, "Can imaging help identify at-risk vulnerable plaques and patients before catastrophe (or those not at risk)," will feature presentations from Patrick W. Serruys, M.D., Gary S. Mintz, M.D., Gregg W. Stone, M.D. and Alexandra Lansky, M.D. The second session, entitled, "Ischemia, FFR and Optimal Revascularization," will include presentations by Gregg W. Stone, M.D., Bernard de Bruyne, M.D., PhD, Bill Fearon, M.D. and Mort Kern, M.D. The event will be held at the Hilton San Francisco in the Imperial Room on Thursday, September 24. A reception will be held from 7:00 PM - 8:00 PM, followed by the symposium from 8:00 PM - 10:00 PM.
Abbott's PROSPECT trial is the first prospective natural history study to examine the role of vulnerable plaque and how it might progress to a cardiac event. PROSPECT used novel intravascular imaging technology to correlate plaque characteristics, patient risk factors and biomarker measurements with subsequent heart attacks and other cardiac events, potentially paving the way for physicians to identify and treat at-risk patients before a heart attack occurs.
About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH(R)) IVUS tissue characterization and ChromaFlo(R). Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) and Forward-Looking IVUS systems and catheters. Currently, more than 4,400 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Through its wholly-owned subsidiary, Axsun Technologies, Volcano also develops and manufactures optical monitors, lasers and optical engines used in telecommunications, spectroscopy and other industrial applications. These products are sold to a variety of customers, including Nokia Siemens, Ericsson, Alcatel-Lucent and HuaWei Technologies. For more information, visit the company's website at http://www.volcanocorp.com.
SOURCE Volcano Corporation
CONTACT: Joe Burnett, Vice President of Volcano Corporation,
+1-916-337-8352
Web site: http://www.volcanocorp.com/
