Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study

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  • David Erlinge, Department of Nephrology in Lund, Clinical Sciences Lund, Skåne University Hospital and Lund University, Lund, Sweden.
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  • Akiko Maehara, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
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  • Ori Ben-Yehuda, Department of Dermatology, University of California, San Diego, California; Department of Pediatrics, University of California, San Diego, California; Rady Children's Hospital, San Diego, California.
  • ,
  • Hans Erik Bøtker
  • Michael Maeng
  • Lars Kjøller-Hansen, Innovational Counsil, Zealand University Hospital, Region Zealand
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  • Thomas Engstrøm, 1Copenhagen University Hospital, Copenhagen, Denmark. 2Aarhus University Hospital, Aarhus, Denmark. 3University of Copenhagen, Copenhagen, Denmark. 4Odense University Hospital, Odense, Denmark.
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  • Mitsuaki Matsumura, Cardiovascular Research Foundation
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  • Aaron Crowley, Cardiovascular Research Foundation
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  • Ovidiu Dressler, Cardiovascular Research Foundation
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  • Gary S Mintz, Cardiovascular Research Foundation
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  • Ole Fröbert, Department of Cardiology, Örebro University Hospital, Örebro
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  • Jonas Persson, Karolinska Univ Hosp, Karolinska University Hospital, Karolinska Institutet, Dept Neurosurg
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  • Rune Wiseth, University Hospital Trondheim, Trondheim, Norway.
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  • Alf Inge Larsen, University of Bergen, Stavanger University Hospital, Stavanger
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  • Lisette Okkels Jensen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
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  • Jan Erik Nordrehaug, Department of Biology, University of Bergen, Bergen, Norway; Sars International Centre, Uni Research, University of Bergen, Bergen, Norway.
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  • Øyvind Bleie, Haukeland Hosp, University of Bergen, Haukeland University Hospital, Dept Radiol
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  • Elmir Omerovic, Univ Gothenburg, Sahlgrenska University Hospital, University of Gothenburg, Sahlgrenska Acad, Sahlgrenska Univ Hosp, Dept Orthopaed
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  • Claes Held, Uppsala University and Uppsala Clinical Research Center, Uppsala University, Sweden.
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  • Stefan K James, Uppsala University and Uppsala Clinical Research Center, Uppsala University, Sweden.
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  • Ziad A Ali, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
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  • James E Muller, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA; Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA, USA.
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  • Gregg W Stone, The Zena and Michael A. Wiener Cardiovascular Institute, USA.
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  • PROSPECT II Investigators

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.

OriginalsprogEngelsk
TidsskriftLancet
Vol/bind397
Nummer10278
Sider (fra-til)985-995
Antal sider11
ISSN0140-6736
DOI
StatusUdgivet - mar. 2021

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