MedicalResearch.com Interview with:
Nick West MA MD FRCP FESC FACC
Chief Medical Officer
MedicalResearch.com: What is the background for the Liquid Biopsy System and this study?
Response: Despite huge advances in the diagnosis and treatment of coronary artery disease, this form of cardiovascular disease remains as the world’s number one cause of death. Although interventions such as coronary angioplasty and cholesterol lowering with statins have improved morbidity, patients still experience high rates of recurrent cardiovascular events. Various technologies have been applied to predict future patient events with limited success, such as ‘virtual histology’ intravascular ultrasound (VH-IVUS) in the PROSPECT study (Stone GW et al. N Engl J Med 2011; 364: 226-235). Many experts acknowledge that imaging alone may be insufficient to gauge risk, and that the utility of a more biological endpoint may be more appropriate. This supposition is supported by recent data that added endothelial shear stress estimation to the PROSPECT data and significantly improved subsequent event prediction (Stone PH et al. JACC Cardiovascular Imaging 2017; Sep 18 epub ahead of print).
Coronary artery disease has long been recognised to be underpinned by an inflammatory pathogenesis, and it is bioactive molecules (growth factors, cytokines etc) within the vasculature that affect plaque growth, transformation and vulnerability to rupture, resulting in myocardial infarction. Measuring these biomolecules in situ is challenging owing to an inability to reliably sample from the ‘boundary layer’ – a slower-moving circumferential stratum of blood adjacent to the endothelial surface that does not mix with the general bulk flow.
The PlaqueTec Liquid Biopsy System™ (LBS) was designed specifically to sample from the boundary layer at four sites simultaneously within the coronary artery, where biomolecules released from plaques are likely to be most concentrated. With the LBS, we can also detect small gradients of released molecules by simultaneously collecting blood both upstream and downstream of individual plaques.
The LBS has demonstrated safety and feasibility in preclinical and preliminary clinical studies, and was awarded a CE mark in Europe as a dedicated coronary blood sampling device in 2014. Continue reading