The following content is from the 2018 Transcatheter Cardiovascular Therapeutics (TCT) presentation.

The Lipid-Rich Plaque Study Overview

Assessment of Coronary Near Infrared Spectroscopy Imaging to Detect Vulnerable Patients and Vulnerable Plaques

Ron Waksman, MD
Principal Investigator, LRP Study
MedStar Washington Hospital Center

We still see many patients that come to the cath lab for one event and have a subsequent event despite being treated with medical therapy. Some of these patients are optimally treated and still have events. The unmet need was to find an imaging technology able to detect vulnerable patients and vulnerable plaques. Doing that could be a good predictorfor subsequent coronary events.

Study Summary

The landmark Lipid-Rich Plaque (LRP) study was designed to demonstrate that intravascular NIRS imaging can identify patients and plaques at risk for subsequent non-culprit major adverse cardiovascular events (NC-MACE) during a 24-month period. The results were presented by Dr. Ron Waksman at TCT 2018 in San Diego.

The study successfully met both its co-primary endpoints as well as its key secondary endpoints, providing clinical evidence that intravascular NIRS imaging can accurately identify both vulnerable patients and vulnerable plaques that are at significantly higher risk for subsequent NC-MACE.

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Study Co-Primary Endpoints

Vulnerable Patient:

Association between maxLCBI4mm in all imaged arteries and future patient-level nonculprit MACE*

Vulnerable Plaque:

Association between maxLCBI4mm in a segment and incidence of future NC-MACE* in same segment

Study Secondary Endpoints

Vulnerable Patient:

A threshold of maxLCBI4mm>400 will identify patients and plaques at increased risk of a NC-MACE*

*Non-culprit MACE (independently adjudicated by CEC blinded to NIRS)

Key Findings

Vulnerable Patient Risk of NC-MACE

Firmly established that LCBI adversely correlates to MACE risk and should be managed.

Vulnerable Plaque Risk of NC-MACE

Firmly established that LCBI adversely correlates to MACE risk and should be managed

87%

increased risk

for patients with overall maxLCBI4mm>400

18%

increased risk

for each 100 units increase in overall maxLCBI4mm

300%

increased risk

for each 30mm Ware segment with maxLCBI4mm>400

45%

increased risk

for each 100 units increase in maxLCBI4mm for each Ware segment

Example Case

The following example represents a typical case study of a patient enrolled in the LRP study and the subsequent observations of that patient.

A 44-year-old male with a past medical history of coronary artery disease, diabetes mellitus, hypertension and hyperlipidemia, presented with chest and right leg pain was imaged and scanned on April 30, 2014. The angiogram showed some non-obstructive plaque; the chemogram indicated that maxLCBI4mm was greater than 400, an indication of risk for subsequent NC-MACE. Twenty-two months later, the patient presented with unstable angina, which required percutaneous coronary intervention (PCI). New NIRS imaging showed that the new culprit lesion was located within the Ware segment previously identified on the chemogram.

LRP Case Study Example

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The Makoto™ Intravascular Imaging System is the only FDA-cleared imaging system indicated for the detection of plaque and patients at higher risk of MACE.

To request more information on how to obtain the Makoto™ system or its accompanying Dualpro™ IVUS+NIRS Catheter, or to see a demo, CLICK HERE

View the LRP study results as presented by PI Ron Waksman at TCT 2018 in San Diego

View results

Review the TCT MD slides

Review slides

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