The Cardiovascular Research Foundation (CRF), New York, USA, and the Uppsala Clinical Research Center (UCR), Uppsala, Sweden, have launched a study (PROSPECT II) and a substudy (PROSPECT ABSORB) to assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques.
PROSPECT II is an investigator initiated multicentre, prospective registry study while PROSPECT ABSORB is an investigator initiated multicentre, randomized trial that (for the first time) will evaluate the ability of a bioresorbable scaffold to safely increase luminal dimensions of vulnerable plaque.
The PROSPECT II study will enrol 900 patients with acute coronary syndrome and will be led by Gregg W Stone (professor of Medicine at Columbia University Medical Center in New York, USA) and David Erlinge (director of the Department of Cardiology, Lund University, Skane University Hospital in Lund, Sweden). Patient enrolment will begin in the first part of 2014 and be completed in approximately one year. The study will be conducted in approximately 16 sites in Scandinavia.
Each patient will be examined with intravascular ultrasound (IVUS) and NIRS in all three coronary arteries. In the PROSPECT ABSORB sub study, 300 patients with a plaque at high risk of causing future coronary events, as shown in the original PROSPECT study (plaque burden ≥70%), will be randomised to treatment with Absorb device (Abbott Vascular) plus guideline directed medical therapy or medical therapy alone, with each patient undergoing angiography and IVUS/NIRS after two years. All 900 patients will be measured at baseline and then followed in the registry for at least three years to detect the occurrence of coronary events. The integrated PROSPECT II and PROSPECT ABSORB study programme is being funded by grants from InfraReDx, The Medicines Company, and Abbott.
“NIRS has been extremely well validated for detecting lipid, which is at the core of most vulnerable plaques. PROSPECT II will determine the ability of NIRS to identify these high risk lesions in an adequately powered prospective study. And PROSPECT ABSORB will, for the first time, test the feasibility of an interventional approach in preventing future major adverse cardiovascular events arising from plaques which appear angiographically innocuous (and are thus not currently stented), but are in fact the source of future acute coronary syndromes. This is truly a groundbreaking investigation,” said Stone.