Trial Outcomes & Findings for The Lipid-Rich Plaque Study (NCT NCT02033694)

NCT ID: NCT02033694

Last Updated: 2020-05-19

Results Overview

Association of maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) as a continuous value in 100 unit increments in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of: * cardiac death * cardiac arrest * non-fatal myocardial infarction (MI) * acute coronary syndrome * revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI) * rehospitalization for progressive angina, related to a non-index culprit lesion

Recruitment status

COMPLETED

Target enrollment

1563 participants

Primary outcome timeframe

2 years

Results posted on

2020-05-19

Participant Flow

Enrolled patients with a large LRP (Maximum Lipid Core Burden Index\>250 in 4 mm or maxLCBI4mm\>=250) were assigned to 2 year follow up to determine if a new coronary event had occurred. A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm\<250) had 2 year follow up.

A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm\<250) did not have 2 year follow up and were not included in the primary analyses. This reduced the total number of patients followed for two years to 1271 patients.

Participant milestones

Participant milestones
Measure	Participants With 2 Year Follow up Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Overall Study STARTED	1271
Overall Study COMPLETED	1271
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Lipid-Rich Plaque Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With 2 Year Follow up n=1271 Participants Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Age, Continuous	64 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	388 Participants n=5 Participants
Sex: Female, Male Male	883 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	942 Participants n=5 Participants
Race/Ethnicity, Customized African American	158 Participants n=5 Participants
Race/Ethnicity, Customized Asian Pacific	44 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	128 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	101 Participants n=5 Participants
Region of Enrollment Netherlands	187 Participants n=5 Participants
Region of Enrollment Latvia	10 Participants n=5 Participants
Region of Enrollment United States	1001 Participants n=5 Participants
Region of Enrollment United Kingdom	46 Participants n=5 Participants
Region of Enrollment Italy	10 Participants n=5 Participants
Region of Enrollment Slovakia	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Patients assigned to 2 year follow up were analyzed, at the patient and plaque level, to test the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE).

Outcome measures

Outcome measures
Measure	Participants With 2 Year Follow up n=1271 Participants Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable Participants with No NC-MACE	1167 Participants
Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable Participants with NC-MACE	104 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Patients assigned to 2 year follow up were analyzed, at the patient and plaque level to test the association between maximum 4mm Lipid Core Burden index (maxLCBI4mm) \>400 and Non-Index Culprit Lesion related Major Cardiac Events (NC-MACE)

Association of maxLCBI4mm more than and less than a threshold of 400 in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of: * cardiac death * cardiac arrest * non-fatal myocardial infarction (MI) * acute coronary syndrome * revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI) * rehospitalization for progressive angina, related to a non-index culprit lesion

Outcome measures

Outcome measures
Measure	Participants With 2 Year Follow up n=1271 Participants Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 Participants with NC-MACE	104 Participants
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 Participants with No NC-MACE	1167 Participants

Adverse Events

All Patients With Baseline NIRS-IVUS Imaging

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients With Baseline NIRS-IVUS Imaging n=1563 participants at risk Participants with NIRS-IVUS imaging at baseline
Cardiac disorders Dissection	0.26% 4/1563 • Number of events 4 • 2 years The device has been approved as safe for imaging of coronary arteries by the FDA. Experience in greater than 5,000 patients has shown that the device safety profile does not differ from that of a conventional IVUS catheter. Serious adverse events associated with the device in the additional, non-culprit vessels were collected because this was the additional requirement for the study outside of routine medical care.
Cardiac disorders Bradycardia	0.06% 1/1563 • Number of events 1 • 2 years The device has been approved as safe for imaging of coronary arteries by the FDA. Experience in greater than 5,000 patients has shown that the device safety profile does not differ from that of a conventional IVUS catheter. Serious adverse events associated with the device in the additional, non-culprit vessels were collected because this was the additional requirement for the study outside of routine medical care.
Cardiac disorders Thrombus with Chest Pain	0.06% 1/1563 • Number of events 1 • 2 years The device has been approved as safe for imaging of coronary arteries by the FDA. Experience in greater than 5,000 patients has shown that the device safety profile does not differ from that of a conventional IVUS catheter. Serious adverse events associated with the device in the additional, non-culprit vessels were collected because this was the additional requirement for the study outside of routine medical care.

Other adverse events

Adverse event data not reported

Additional Information

Priti Shah

Infraredx, A Nipro Company

Phone: 781-345-9646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place