Elsevier

American Heart Journal

Volume 192, October 2017, Pages 98-104
American Heart Journal

Trial Design
The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale

https://doi.org/10.1016/j.ahj.2017.02.010Get rights and content

Background

It has been hypothesized that the outcome post-PCI could be improved by the detection and subsequent treatment of vulnerable patients and lipid-rich vulnerable coronary plaques (LRP). A near-infrared spectroscopy (NIRS) catheter capable of detecting LRP is being evaluated in The Lipid-Rich Plaque Study.

Study design

The LRP Study is an international, multicenter, prospective cohort study conducted in patients with suspected coronary artery disease (CAD) who underwent cardiac catheterization with possible ad hoc PCI for an index event. Patient level and plaque level events were detected by follow-up in the subsequent 2 years.

Enrollment began in February 2014 and was completed in March 2016; a total of 1,562 patients were enrolled. Adjudication of new coronary event occurrence and de novo culprit lesion location during the 2-year follow-up is performed by an independent clinical end-points committee (CEC) blinded to NIRS-IVUS findings.

The first analysis of the results will be performed when at least 20 de novo events have occurred for which follow-up angiographic data and baseline NIRS-IVUS measurements are available. It is expected that results of the study will be announced in 2018.

Summary

The LRP Study will test the hypotheses that NIRS-IVUS imaging to detect LRP in patients can identify vulnerable patients and vulnerable plaques. Identification of vulnerable patients will assist future studies of novel systemic therapies; identification of localized vulnerable plaques would enhance future studies of possible preventive measures.

Section snippets

Cross-sectional observations of NIRS-IVUS imaging

NIRS has been rigorously validated against autopsy specimens and is the only technology to carry an FDA label claim for the detection of lipid core.15., 16. Studies of the combined NIRS-IVUS system have consistently demonstrated its utility as compared to IVUS alone or NIRS alone.17

NIRS-IVUS imaging in patients who have already experienced a coronary event has detected a high incidence of lipid and large plaque burden at culprit lesion sites.18., 19. Madder et al. demonstrated that large

Prospective utility of NIRS-IVUS imaging

In aggregate, there are multiple lines of evidence suggesting that NIRS-IVUS imaging has the potential to provide a measure of vulnerable coronary plaque that is of value for more precise categorization of coronary patients. Given this array of promising NIRS-IVUS data, the decision was made in 2014 to launch the prospective, multicenter Lipid-Rich Plaque (LRP) outcomes study (NCT02033694). The study was designed to test the hypotheses in a cohort of over 1,500 patients undergoing cardiac

Design of the LRP study

The aim of the LRP study is to evaluate the correlation between the presence of non-flow-limiting, non-intervened lipid-rich plaques detected by NIRS-IVUS imaging in two or more coronary arteries and the development of a major adverse cardiac event (MACE) caused by a de novo culprit lesion within the 24 months post-imaging. Inclusion criteria are listed in Table I. MACE is defined as the composite incidence of cardiac death, cardiac arrest, myocardial infarction, revascularization, acute

Summary

The LRP study will test the hypotheses that NIRS-IVUS imaging to detect LRP in patients who have undergone a cardiac catheterization can identify vulnerable patients and vulnerable plaques. Identification of vulnerable patients will assist future studies of novel systemic therapies; identification of vulnerable plaques will lead to studies that can evaluate local plus systemic treatment of the plaques likely to cause future events.

References (24)

  • P. Libby et al.

    Effects of statins in reducing thrombotic risk and modulating plaque vulnerability

    Clin Cardiol

    (2003)
    G.W. Stone et al.

    A prospective natural-history study of coronary atherosclerosis

    N Engl J Med

    (2011)
  • C.J. Schultz et al.

    First-in-man clinical use of combined near-infrared spectroscopy and intravascular ultrasound: a potential key to predict distal embolization and no-reflow?

    J Am Coll Cardiol

    (2010)
  • Cited by (0)

    RCT# NCT02033694

    Relationship with industry:

    • Ron Waksman, MD, Consultant: Abbott Vascular, Biotronik, Boston Scientific, Medtronic, St. Jude Medical; Speakers Bureau: AstraZeneca, Boston Scientific, Merck; Grant Support: Infraredx, AstraZeneca, Biotronik, and Boston Scientific

    • Sean Madden, PhD, Employee, Infraredx, Inc.

    • Priti Shah, MS, Employee, Infraredx, Inc.

    • James Muller, MD, Consultant, Infraredx, Inc.

    Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT02033694.

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