Study in The Lancet successfully demonstrated endpoints of identifying both vulnerable patients & plaques at a significantly higher risk for subsequent MACE. View now View Now

Study Design & Methodology

Hypothesis

Intravascular NIRS imaging can identify patients and plaques at risk for NC-MACE during a 24-month period.

 

Methodology

A total of 1,271 patients were imaged at baseline and followed for 24 months for future NC-MACE.

Statistical Methodology

The co-primary endpoints assessed maxLCBI4mm as a continuous variable using time-to-event Cox proportional hazard models. The key secondary endpoints were assessed with the maxLCBI4mm dichotomized at 400.

Ware segments
The analysis unit for both index procedure analysis and event adjudication was defined by paired standardized 30 mm segments (Proximal, Mid, Distal, and Far Distal).

Vulnerable Patient-Level Analysis

MaxLCBI4mm was computed from all eligible non-culprit scanned area NC-MACE evaluated at a patient level

Vulnerable Plaque-Level Analysis

Evaluation was conditional on the Patient-Level being met
MaxLCBI4mm was computed in each eligible Ware segments
NC-MACE evaluated only in corresponding segments where imaging occurred

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