News | January 21, 2011

PROSPECT: IVUS Assesses Risk of Future Vulnerable Plaque Ruptures

A comparison showing the same lesions imaged with grayscale IVUS (left), and color-coded virtual histology that characterizes the plaque.

Intravascular ultrasound (IVUS) enabled physicians to more accurately assess the risk of individual blockages than the use of the current standard of angiographic imaging alone, according to a new study. The results from the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study were published this week in The New England Journal of Medicine.

Investigators used grayscale IVUS and Volcano Corporation’s Virtual Histology (VH)-IVUS tissue characterization software to evaluate suspected vulnerable plaques in the coronary arteries.

“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,” said Gregg W. Stone, M.D., the study’s principal investigator 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. “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 (ACS). The study followed 700 U.S. and European patients with ACS 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.

“The need to improve patient care and reduce cost has led to more personalized medicine,” Scott Huennekens, Volcano’s president and CEO. “For personalized 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 percent 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 percent out to three years. These lesions were termed “protective” by the investigators.

For more information: www.nejm.org

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init