Volcano announced the publication of results from the PROSPECT (Providing regional observations to study predictors of events in the coronary tree) study in The New England Journal of Medicine showing that grayscale intravascular ultrasound (IVUS) and Volcano’s proprietary VH IVUS tissue characterisation software enable physicians to more accurately assess the risk of individual blockages than the use of the current standard of care angiographic imaging alone.
Gregg W. Stone, principal investigator of the PROSPECT study and professor of Medicine at Columbia University College of Physicians and Surgeons, director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, said, “The landmark PROSPECT study has confirmed two key principles that will be relevant as we continue to innovate and improve our treatment of cardiovascular disease. First, angiographic guidance alone is not a good predictor of future events; grayscale intravascular ultrasound is much better than angiography at determining the severity of plaque, and which blockages are most likely to cause future events. Second, all coronary artery disease is not the same, and differences in underlying tissue type can in fact change the risk profile of a lesion. Some blockages are more active and can quickly progress to a clinical event. Other blockages are more stable, and when combined with proper medical therapy, have an extremely low risk of causing a future event. For the first time, we have been able to prospectively identify these lesions both by size and by tissue type using VH IVUS.”
The PROSPECT study, which was funded by Abbott and Volcano, is the first and only natural history study that tracked the clinical outcomes, hospital readmissions, and subsequent coronary events of patients with acute coronary syndrome. The study followed 700 US and European patients over three years. The investigators assessed these patients’ coronary arteries by taking very detailed measurements and interior images of all three arteries. The PROSPECT study showed that of the 55 imaging parameters measured, grayscale IVUS and VH IVUS identified the only individual parameters that could statistically predict lesion risk for future clinical events. When combined together, grayscale IVUS and VH IVUS uncovered lesion characteristics that PROSPECT showed predict the highest lesion risk for future clinical events.
Scott Huennekens, president and CEO commented, “The need to improve patient care and reduce cost has led to more personalised medicine. For personalised medicine to work, we must rely on better diagnostic tools to determine which patients will or will not benefit from therapy. PROSPECT shows us that we can go beyond the limitations of a two-dimensional X-ray and better separate these blockages into higher risk and lower risk.”
The investigators found that certain high-risk lesions, including those with a relatively small lumen area and a large amount of plaque, and a significant amount of dead tissue or necrosis near the lumen as identified by VH IVUS, had an almost 20% risk of a cardiac event within three years. These lesions were classified as ‘predictive’ by the investigators. Conversely, certain low-risk lesions where that same necrotic tissue was not present in the study had a significantly lower event rate of only 0.6% out to three years. The investigators termed these lesions as ‘protective’.
“Heart disease is the number one killer in the world,” said Pauliina Margolis, chief medical officer at Volcano. “The more we can understand about the disease we are treating, the further we can advance as a cardiology community. VH IVUS tissue characterisation has been studied in more than 10,000 patients globally. PROSPECT has provided an important step forward by showing that we can see a difference in lesions, supported by clinical evidence.”