Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Issue 10278 (13th March 2021)

• Record Type: Journal Article
• Authors: Erlinge, David; Maehara, Akiko; Ben-Yehuda, Ori; Bøtker, Hans Erik; Maeng, Michael; Kjøller-Hansen, Lars; Engstrøm, Thomas; Matsumura, Mitsuaki; Crowley, Aaron; Dressler, Ovidiu; Mintz, Gary S; Fröbert, Ole; Persson, Jonas; Wiseth, Rune; Larsen, Alf Inge; Okkels Jensen, Lisette; Nordrehaug, Jan Erik; Bleie, Øyvind; Omerovic, Elmir; Held, Claes; James, Stefan K; Ali, Ziad A; Muller, James E; Stone, Gregg W; Ahlehoff, Ole; Amin, Azad; Angerås, Oskar; Appikonda, Praveen; Balachandran, Saranya; Barvik, Ståle; Bendix, Kristoffer; Bertilsson, Maria; Boden, Ulrika; Bogale, Nigussie; Bonarjee, Vernon; Calais, Fredrik; Carlsson, Jörg; Carstensen, Steen; Christersson, Christina; Christiansen, Evald Høj; Corral, Maria; De Backer, Ole; Dhaha, Usama; Dworeck, Christian; Eggers, Kai; Elfström, Charlotta; Ellert, Julia; Eriksen, Erlend; Fallesen, Christian; Forsman, Margareta; Fransson, Helena; Gaballa, Mohsen; Gacki, Marek; Götberg, Matthias; Hagström, Lars; Hallberg, Theresa; Hambraeus, Kristina; Haraldsson, Inger; Harnek, Jan; Havndrup, Ole; Hegbom, Knut; Heigert, Matthias; Helqvist, Steffen; Herstad, Jon; Hijazi, Ziad; Holmvang, Lene; Ioanes, Dan; Iqbal, Amjid; Iversen, Allan; Jacobson, Jaclyn; Jakobsen, Lars; Jankovic, Ivana; Jensen, Ulf; Jensevik, Karin; Johnston, Nina; Jonasson, Torfi Fjalar; Jørgensen, Erik; Joshi, Francis; Kajermo, Ulf; Kåver, Frida; Kelbæk, Henning; Kellerth, Thomas; Kish, Mitra; Koenig, Wolfgang; Koul, Sasha; Lagerqvist, Bo; Larsson, Bertil; Lassen, Jens Flensted; Leiren, Olav; Li, Zhe; Lidell, Christer; Linder, Rikard; Lindstaedt, Michael; Lindström, Gunilla; Liu, Shen; Løland, Kjetil Halvorsen; Lønborg, Jacob; Márton, László; Mir-Akbari, Habib; Mohamed, Shameema; Odenstedt, Jacob; Ogne, Christer; Oldgren, Jonas; Olivecrona, Göran; Östlund-Papadogeorgos, Nikolas; Ottesen, Michael; Packer, Erik; Palmquist, Åsa Michelgård; Paracha, Quratulain; Pedersen, Frans; Petursson, Petur; Råmunddal, Truls; Rotevatn, Svein; Sanchez, Raquel; Sarno, Giovanna; Saunamäki, Kari I; Scherstén, Fredrik; Serruys, Patrick W; Sjögren, Iwar; Sørensen, Rikke; Srdanovic, Iva; Subhani, Zuka; Svensson, Eva; Thuesen, Anne; Tijssen, Jan; Tilsted, Hans-Henrik; Tödt, Tim; Trovik, Thor; Våga, Bjørn Inge; Varenhorst, Christoph; Veien, Karsten; Vestman, Emma; Völz, Sebastian; Wallentin, Lars; Wykrzykowska, Joanna; Zagozdzon, Leszek; Zamfir, Manuela; Zedigh, Crister; Zhong, Hang; Zhou, Zhipeng;
• Is Part Of: Lancet. Volume 397:Issue 10278(2021)
• Page Start: 985
• Page End: 995
• Publication Date: 2021-03-13
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Medicine; Electronic journals; Periodicals; 610.5
• DOI: 10.1016/S0140-6736(21)00249-X
• Languages: English
• ISSNs: 0140-6736

Abstract

Summary: 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.