Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study

LRP Investigators

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. Methods: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (<250 maxLCBI4mm) were followed up for 24 months. This study is registered with ClinicalTrials.gov, NCT02033694. Findings: Between Feb 21, 2014, and March 30, 2016, 1563 patients were enrolled. NIRS-intravascular ultrasound device-related events were seen in six (0·4%) patients. 1271 patients (mean age 64 years, SD 10, 883 [69%] men, 388 [31%]women) with analysable maxLCBI4mm were allocated to follow-up. The 2-year cumulative incidence of NC-MACE was 9% (n=103). Both hierarchical primary hypotheses were met. On a patient level, the unadjusted hazard ratio (HR) for NC-MACE was 1·21 (95% CI 1·09–1·35; p=0·0004) for each 100-unit increase maxLCBI4mm) and adjusted HR 1·18 (1·05–1·32; p=0·0043). In patients with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 2·18 (1·48–3·22; p<0·0001) and adjusted HR was 1·89 (1·26–2·83; p=0·0021). At the plaque level, the unadjusted HR was 1·45 (1·30–1·60; p<0·0001) for each 100-unit increase in maxLCBI4mm. For segments with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 4·22 (2·39–7·45; p<0·0001) and adjusted HR was 3·39 (1·85–6·20; p<0·0001). Interpretation: NIRS imaging of non-obstructive territories in patients undergoing cardiac catheterisation and possible percutaneous coronary intervention was safe and can aid in identifying patients and segments at higher risk for subsequent NC-MACE. NIRS-intravascular ultrasound imaging adds to the armamentarium as the first diagnostic tool able to detect vulnerable patients and plaques in clinical practice. Funding: Infraredx.

Original languageEnglish (US)
Pages (from-to)1629-1637
Number of pages9
JournalThe Lancet
Volume394
Issue number10209
DOIs
StatePublished - Nov 2 2019
Externally publishedYes

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Near-Infrared Spectroscopy
Ultrasonography
Cohort Studies
Prospective Studies
Lipids
Percutaneous Coronary Intervention
Cardiac Catheterization
Latvia
Slovakia
Acute Coronary Syndrome
Netherlands
Italy
Coronary Artery Disease

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging : a prospective, cohort study. / LRP Investigators.

In: The Lancet, Vol. 394, No. 10209, 02.11.2019, p. 1629-1637.

Research output: Contribution to journalArticle

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title = "Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study",
abstract = "Background: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. Methods: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (<250 maxLCBI4mm) were followed up for 24 months. This study is registered with ClinicalTrials.gov, NCT02033694. Findings: Between Feb 21, 2014, and March 30, 2016, 1563 patients were enrolled. NIRS-intravascular ultrasound device-related events were seen in six (0·4{\%}) patients. 1271 patients (mean age 64 years, SD 10, 883 [69{\%}] men, 388 [31{\%}]women) with analysable maxLCBI4mm were allocated to follow-up. The 2-year cumulative incidence of NC-MACE was 9{\%} (n=103). Both hierarchical primary hypotheses were met. On a patient level, the unadjusted hazard ratio (HR) for NC-MACE was 1·21 (95{\%} CI 1·09–1·35; p=0·0004) for each 100-unit increase maxLCBI4mm) and adjusted HR 1·18 (1·05–1·32; p=0·0043). In patients with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 2·18 (1·48–3·22; p<0·0001) and adjusted HR was 1·89 (1·26–2·83; p=0·0021). At the plaque level, the unadjusted HR was 1·45 (1·30–1·60; p<0·0001) for each 100-unit increase in maxLCBI4mm. For segments with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 4·22 (2·39–7·45; p<0·0001) and adjusted HR was 3·39 (1·85–6·20; p<0·0001). Interpretation: NIRS imaging of non-obstructive territories in patients undergoing cardiac catheterisation and possible percutaneous coronary intervention was safe and can aid in identifying patients and segments at higher risk for subsequent NC-MACE. NIRS-intravascular ultrasound imaging adds to the armamentarium as the first diagnostic tool able to detect vulnerable patients and plaques in clinical practice. Funding: Infraredx.",
author = "{LRP Investigators} and Ron Waksman and {Di Mario}, Carlo and Rebecca Torguson and Ali, {Ziad A.} and Varinder Singh and Skinner, {William H.} and Artis, {Andre K.} and Cate, {Tim Ten} and Eric Powers and Christopher Kim and Evelyn Regar and Wong, {S. Chiu} and Stephen Lewis and Joanna Wykrzykowska and Sandeep Dube and Samer Kazziha and {van der Ent}, Martin and Priti Shah and Craig, {Paige E.} and Quan Zou and Paul Kolm and Brewer, {H. Bryan} and Garcia-Garcia, {Hector M.} and Habib Samady and Jonathan Tobis and Mark Zainea and Wayne Leimbach and Daniel Lee and Thomas Lalonde and William Skinner and Augusto Villa and Henry Liberman and George Younis and {de Silva}, Ranil and Miguel Diaz and Luis Tami and John Hodgson and Ganesh Raveendran and Nilesh Goswami and Jose Arias and Lawrence Lovitz and Robert Carida and Srinivasa Potluri and Francesco Prati and Andrejs Erglis and Andrei Pop and Margaret McEntegart and Martin Hudec and Umamahesh Rangasetty and David Newby",
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TY - JOUR

T1 - Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging

T2 - a prospective, cohort study

AU - LRP Investigators

AU - Waksman, Ron

AU - Di Mario, Carlo

AU - Torguson, Rebecca

AU - Ali, Ziad A.

AU - Singh, Varinder

AU - Skinner, William H.

AU - Artis, Andre K.

AU - Cate, Tim Ten

AU - Powers, Eric

AU - Kim, Christopher

AU - Regar, Evelyn

AU - Wong, S. Chiu

AU - Lewis, Stephen

AU - Wykrzykowska, Joanna

AU - Dube, Sandeep

AU - Kazziha, Samer

AU - van der Ent, Martin

AU - Shah, Priti

AU - Craig, Paige E.

AU - Zou, Quan

AU - Kolm, Paul

AU - Brewer, H. Bryan

AU - Garcia-Garcia, Hector M.

AU - Samady, Habib

AU - Tobis, Jonathan

AU - Zainea, Mark

AU - Leimbach, Wayne

AU - Lee, Daniel

AU - Lalonde, Thomas

AU - Skinner, William

AU - Villa, Augusto

AU - Liberman, Henry

AU - Younis, George

AU - de Silva, Ranil

AU - Diaz, Miguel

AU - Tami, Luis

AU - Hodgson, John

AU - Raveendran, Ganesh

AU - Goswami, Nilesh

AU - Arias, Jose

AU - Lovitz, Lawrence

AU - Carida, Robert

AU - Potluri, Srinivasa

AU - Prati, Francesco

AU - Erglis, Andrejs

AU - Pop, Andrei

AU - McEntegart, Margaret

AU - Hudec, Martin

AU - Rangasetty, Umamahesh

AU - Newby, David

PY - 2019/11/2

Y1 - 2019/11/2

N2 - Background: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. Methods: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (<250 maxLCBI4mm) were followed up for 24 months. This study is registered with ClinicalTrials.gov, NCT02033694. Findings: Between Feb 21, 2014, and March 30, 2016, 1563 patients were enrolled. NIRS-intravascular ultrasound device-related events were seen in six (0·4%) patients. 1271 patients (mean age 64 years, SD 10, 883 [69%] men, 388 [31%]women) with analysable maxLCBI4mm were allocated to follow-up. The 2-year cumulative incidence of NC-MACE was 9% (n=103). Both hierarchical primary hypotheses were met. On a patient level, the unadjusted hazard ratio (HR) for NC-MACE was 1·21 (95% CI 1·09–1·35; p=0·0004) for each 100-unit increase maxLCBI4mm) and adjusted HR 1·18 (1·05–1·32; p=0·0043). In patients with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 2·18 (1·48–3·22; p<0·0001) and adjusted HR was 1·89 (1·26–2·83; p=0·0021). At the plaque level, the unadjusted HR was 1·45 (1·30–1·60; p<0·0001) for each 100-unit increase in maxLCBI4mm. For segments with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 4·22 (2·39–7·45; p<0·0001) and adjusted HR was 3·39 (1·85–6·20; p<0·0001). Interpretation: NIRS imaging of non-obstructive territories in patients undergoing cardiac catheterisation and possible percutaneous coronary intervention was safe and can aid in identifying patients and segments at higher risk for subsequent NC-MACE. NIRS-intravascular ultrasound imaging adds to the armamentarium as the first diagnostic tool able to detect vulnerable patients and plaques in clinical practice. Funding: Infraredx.

AB - Background: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. Methods: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (<250 maxLCBI4mm) were followed up for 24 months. This study is registered with ClinicalTrials.gov, NCT02033694. Findings: Between Feb 21, 2014, and March 30, 2016, 1563 patients were enrolled. NIRS-intravascular ultrasound device-related events were seen in six (0·4%) patients. 1271 patients (mean age 64 years, SD 10, 883 [69%] men, 388 [31%]women) with analysable maxLCBI4mm were allocated to follow-up. The 2-year cumulative incidence of NC-MACE was 9% (n=103). Both hierarchical primary hypotheses were met. On a patient level, the unadjusted hazard ratio (HR) for NC-MACE was 1·21 (95% CI 1·09–1·35; p=0·0004) for each 100-unit increase maxLCBI4mm) and adjusted HR 1·18 (1·05–1·32; p=0·0043). In patients with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 2·18 (1·48–3·22; p<0·0001) and adjusted HR was 1·89 (1·26–2·83; p=0·0021). At the plaque level, the unadjusted HR was 1·45 (1·30–1·60; p<0·0001) for each 100-unit increase in maxLCBI4mm. For segments with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 4·22 (2·39–7·45; p<0·0001) and adjusted HR was 3·39 (1·85–6·20; p<0·0001). Interpretation: NIRS imaging of non-obstructive territories in patients undergoing cardiac catheterisation and possible percutaneous coronary intervention was safe and can aid in identifying patients and segments at higher risk for subsequent NC-MACE. NIRS-intravascular ultrasound imaging adds to the armamentarium as the first diagnostic tool able to detect vulnerable patients and plaques in clinical practice. Funding: Infraredx.

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UR - http://www.scopus.com/inward/citedby.url?scp=85074173506&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(19)31794-5

DO - 10.1016/S0140-6736(19)31794-5

M3 - Article

C2 - 31570255

AN - SCOPUS:85074173506

VL - 394

SP - 1629

EP - 1637

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10209

ER -