TY - JOUR

T1 - Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II)

T2 - a prospective natural history study

AU - Erlinge, David

AU - Maehara, Akiko

AU - Ben-Yehuda, Ori

AU - Bøtker, Hans Erik

AU - Maeng, Michael

AU - Kjøller-Hansen, Lars

AU - Engstrøm, Thomas

AU - Matsumura, Mitsuaki

AU - Crowley, Aaron

AU - Dressler, Ovidiu

AU - Mintz, Gary S.

AU - Fröbert, Ole

AU - Persson, Jonas

AU - Wiseth, Rune

AU - Larsen, Alf Inge

AU - Okkels Jensen, Lisette

AU - Nordrehaug, Jan Erik

AU - Bleie, Øyvind

AU - Omerovic, Elmir

AU - Held, Claes

AU - James, Stefan K.

AU - Ali, Ziad A.

AU - Muller, James E.

AU - Stone, Gregg W.

AU - Ahlehoff, Ole

AU - Amin, Azad

AU - Angerås, Oskar

AU - Appikonda, Praveen

AU - Balachandran, Saranya

AU - Barvik, Ståle

AU - Bendix, Kristoffer

AU - Bertilsson, Maria

AU - Boden, Ulrika

AU - Bogale, Nigussie

AU - Bonarjee, Vernon

AU - Calais, Fredrik

AU - Carlsson, Jörg

AU - Carstensen, Steen

AU - Christersson, Christina

AU - Christiansen, Evald Høj

AU - Corral, Maria

AU - De Backer, Ole

AU - Helqvist, Steffen

AU - Holmvang, Lene

AU - Iversen, Allan

AU - Jørgensen, Erik

AU - Kelbæk, Henning

AU - Lønborg, Jacob

AU - Sørensen, Rikke

AU - Thuesen, Anne

AU - PROSPECT II Investigators

N1 - Funding Information: PROSPECT II was an investigator-sponsored study, was designed by DE and GWS, the principal investigators, and was sponsored and done by two academic research organisations with grant funding from Abbott Vascular, Infraredx, and The Medicines Company. DE tweets as @DavidErlinge and GWS tweets as @GreggWStone. Publisher Copyright: © 2021 Elsevier Ltd

PY - 2021/3/13

Y1 - 2021/3/13

N2 - Background: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). Methods: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. Findings: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55–70] years). Median follow-up was 3·7 (IQR 3·0–4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0–15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2–10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25–4·13) and non-culprit lesion-specific MACEs (7·83, 4·12–14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0–10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4–17·6). Interpretation: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. Funding: Abbott Vascular, Infraredx, and The Medicines Company.

AB - Background: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). Methods: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. Findings: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55–70] years). Median follow-up was 3·7 (IQR 3·0–4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0–15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2–10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25–4·13) and non-culprit lesion-specific MACEs (7·83, 4·12–14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0–10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4–17·6). Interpretation: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. Funding: Abbott Vascular, Infraredx, and The Medicines Company.

U2 - 10.1016/S0140-6736(21)00249-X

DO - 10.1016/S0140-6736(21)00249-X

M3 - Journal article

C2 - 33714389

AN - SCOPUS:85102286136

VL - 397

SP - 985

EP - 995

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10278

ER -