Feature | November 07, 2013

PROSPECT II Clinical Trial to Examine Preemptive Bioresorbable Stenting of Vulnerable Plaques

stents bioresorbable cath lab intravascular imaging clinical trial study abbott
November 7, 2013 — The Cardiovascular Research Foundation (CRF) and the Uppsala Clinical Research Center (UCR) of Uppsala, Sweden announced the initiation of the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT II) trial and the PROSPECT ABSORB sub study. PROSPECT II is an investigator-initiated multicenter, prospective registry study that will assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques that subsequently lead to coronary events. PROSPECT ABSORB is an investigator-initiated multicenter, randomized trial that will, for the first time, evaluate the ability of a bioresorbable scaffold to safely increase luminal dimensions of vulnerable plaque.
The PROSPECT II study will enroll 900 patients with acute coronary syndrome (ACS) and will be led by Gregg Stone M.D., professor of medicine, College of Physicians and Surgeons, Columbia University, New York, director, Cardiovascular Research and Education, Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital/Columbia University Medical Center and co-director, Medical Research and Education Division, CRF and David Erlinge, M.D, Ph.D., director, department of cardiology, Lund University, Skane University Hospital, Lund, Sweden. Patient enrollment 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 percent), will be randomized to treatment with Abbott Vascular’s Absorb Bioresorbable Vascular Scaffold (BVS) plus guideline directed medical therapy (GDMT) or GDMT 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 program is being funded by grants from InfraReDx, The Medicines Company and Abbott. Uppsala Clinical Research Center (UCR) will have the operational responsibility and be the sponsor of the study. The study will be conducted in academic partnership with the CRF Clinical Trials Center (CTC).
Data from the original PROSPECT trial demonstrated for the first time prospectively that vulnerable plaques that are most likely to cause sudden unexpected adverse cardiac events can be identified through imaging techniques months to years before the adverse events occur. These study findings were published in the Jan. 20, 2011 issue of the New England Journal of Medicine.
“Using the NIRS imaging technology to detect lipid rich plaque (LRP) has been an eye-opener for us. We can see in vivo that close to all patients with a ST-elevation myocardial infarction (STEMI) exhibit a LRP at the culprit site. In PROSPECT II we will determine the importance of LRP prospectively so that in the future, we can hopefully identify and treat the vulnerable plaque before the infarction happens,” said Erlinge.
“Findings from the original PROSPECT study have helped physicians identify those lesions that are at especially high risk of causing future adverse cardiovascular events using a combination of imaging modalities based on IVUS,” said Stone.
“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.”
For more information: www.crf.org, www.ucr.uu.se

Related Content

coherex Wave Crest LAA Occluder

Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

News | November 24, 2015
November 24, 2015 — Biosense Webster announced it has acquired Coherex Medical Inc., a privately held medical device
Feature | Cath Lab| November 24, 2015
November 24, 2015 — The U.S.
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

Image courtesy of Boston Scientific

News | Left Atrial Appendage (LAA) Occluders| November 20, 2015
Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device
protein reprogramming, Stem Cells Translational Medicine, cardiac progenitor cells, CPCs, regenerative therapies
News | Stem Cell Therapies| November 13, 2015
A new study appearing in STEM CELLS Translational Medicine (SCTM) describes a highly efficient, protein-based method...
angina, abnormal heart blood flow, female-pattern heart disease, Cedars-Sinai Heart Institute study, AHA Scientific Sessions
News | Cardiac Diagnostics| November 13, 2015
Chest pain in female-pattern heart disease is linked with abnormal heart blood flow, a new Cedars-Sinai Heart Institute...
News | Antiplatelet and Anticoagulation Therapies| November 12, 2015
Preventing blood clots with drugs such as heparin has become a common practice for fighting some heart and lung...
pharmacist-physician collaboration, high blood pressure control, minority and low-income populations
News | Hypertension| November 12, 2015
November 12, 2015 — A pharmacist-physician collaborative effort to control blood pressure among a diverse group of pa
obese kids, eight years old, heart disease, MRI, Linyuan Jing
News | Cardiac Diagnostics| November 11, 2015
Imaging tests of obese children — some as young as 8 years old — showed signs of significant heart disease and heart...
Overlay Init