Infraredx has announced the first patient enrolled in PROSPECT II, a multicentre, prospective study designed to assess the ability of intravascular imaging to identify non-flow obstructing vulnerable plaques.
Lipid core plaque, which is suspected to be vulnerable plaque, is a type of fatty coronary artery plaque implicated in most heart attacks, and will be identified using the Infraredx TVC Imaging System, a first-in-class dual modality intravascular imaging system. The study’s first patient was enrolled by David Erlinge, one of the study’s principal investigators, from Lund University in Sweden.
The TVC Imaging System is the only device approved by the FDA to detect the presence of lipid core plaque. The technology integrates near-infrared spectroscopy (NIRS) to detect lipid core plaque, with enhanced intravascular ultrasound (IVUS) to visualise the vessel structure, and is used to guide percutaneous coronary interventions (PCI).
“There is mounting clinical evidence pointing to the role of lipid-rich plaque as the main cause of heart attacks,” says Erlinge. “The PROSPECT II study will allow us to test our hypotheses that NIRS-IVUS imaging can identify the vulnerable plaques that cause heart attacks, and that pre-emptive treatment of the most dangerous plaques with percutaneous coronary interventions can prevent the development of further narrowing of the coronary arteries, as well as plaque erosion and rupture.”
Infraredx will provide the primary funding for the study, with additional support from The Medicines Company and Abbott Vascular.
In 2011, the New England Journal of Medicine published results from the original PROSPECT study, which was the first to prospectively demonstrate that vulnerable plaques can be identified through imaging techniques months to years before adverse events occur. The PROSPECT II study, which will enroll 900 patients at 16 leading cardiac catherisation laboratories across Scandinavia, will use the TVC Imaging System to identify vulnerable plaques in the three major coronary arteries and follow patients for at least three years to detect the occurrence of coronary events. In addition, 300 patients with “bulky” plaques (detected by intravascular ultrasound), which have been shown to be at high risk for causing future adverse events in the first PROSPECT study, will be randomly assigned to treatment with Abbott’s Absorb Bioresorbable Vascular Scaffold (BVS) or optimal medical therapy.
Absorb is a first-of-its-kind device which is under investigation in the USA, and received CE mark approval in 2011. Absorb functions similarly to a stent and is designed to open a blocked vessel and restore blood flow, but because it is made from bioresorbable materials similar to dissolving stitches, it dissolves completely over time. Absorb is called a scaffold to indicate its temporary nature. In data from international studies, regression of plaque has been observed at the site where Absorb has been implanted, a unique effect not typically seen with permanent metallic stents. Data from this sub-study, termed PROSPECT-ABSORB, will be analysed in patients with and without a cholesterol signal at the site of the large plaque, making this the first large-scale study of the identification and preventive treatment of vulnerable plaques.
“We are proud to partner with global leaders in cardiovascular medicine and business to sponsor the PROSPECT II Absorb study,” says Donald Southard, president and chief executive officer of Infraredx. “This study, along with other outcomes studies Infraredx is sponsoring, is designed to prove that vulnerable plaques exist and can be detected in a highly specific manner with the TVC Imaging System. We believe that positive outcomes of these studies will establish our proprietary TVC Imaging NIRS-IVUS technology as the standard of care for guiding the 3 million PCIs performed worldwide each year, and position Infraredx as a leader in what we believe will become a multi-billion dollar intravascular imaging market. Most importantly, successfully treating these vulnerable plaques will improve the quality of life for our patients and result in significant cost savings to healthcare systems worldwide.”
The PROSPECT II study was prompted by promising new data on the ability of the TVC Imaging System to detect large vulnerable plaques precisely at the coronary artery sites at which an ST-segment elevation myocardial infarction (STEMI) occurred causing a dangerous type of heart attack.