Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Официальное название

Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Обзор

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT. This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

Вмешательства

• Диагностический тест OCT, FFR, CTA and FFRCT
  Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT

Первичные конечные точки

• OCT vs. FFR [Срок оценки: Measurement at Procedure/ Baseline Visit]
• OCT vs. FFR [Срок оценки: Measurement at Procedure/ Baseline Visit]
• FFRCT vs. FFR [Срок оценки: Measurement at Procedure/ Baseline Visit]

Вторичные конечные точки (12)

• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR [Срок оценки: Measurement at Procedure/ Baseline Visit]
• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT [Срок оценки: Measurement at Procedure/ Baseline Visit]
• OCT vs. FFR, RFR, resting Pd/Pa, FFRCT [Срок оценки: Measurement at Procedure/ Baseline Visit]
• OCT vs. CTA [Срок оценки: Measurement at Procedure/ Baseline Visit]
• OCT vs. CTA [Срок оценки: Measurement at Procedure/ Baseline Visit]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]
• Clinical endpoint at 1 year [Срок оценки: 12 Month]

Критерии участия

Критерии включения

• Unprotected LM lesion \[midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)\] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
• Age ≥18 years.
• Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.

Критерии исключения

• Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery \[LAD\] or left circumflex artery \[LCX\], except for ostium of LAD or LCX or diseased side branch \[e.g. diagonal branch, obtuse marginal branch\])
• Ostial LM disease.
• Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
• LM In-stent restenosis.
• Previous coronary stenting of the left coronary system.
• Chronic total occlusion.
• Previous coronary artery bypass graft.
• Previous MI related to the left coronary artery.
• Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
• The presence of hemodynamic instability.
• Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
• Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
• Life expectancy less than 1 year.
• Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
• Body mass index >35kg/m2.
• Complex congenital heart disease other than anomalous coronary origins alone.
• Ventricular septal defect.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Япония · 6 центров

• Ageo Central General Hospital — Ageo
• Gifu heart center — Gifu
• Department of Cardiovascular Medicine Shinshu University School of Medicine — Nagano
• Kansai Medical University, — Osaka
• Medical Corporation Ouyuukai Tokorozawa Heart Center — Saitama
• Sapporo Higashi Tokushukai Hospital — Sapporo

Франция · 3 центра

• Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand
• Institute Mutualiste Montsouris — Paris
• Centre Cardiologique du Nord — Saint-Denis

Германия · 2 центра

• Universitätsklinikum Giessen Justus-Liebig Universität — Giessen
• Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie — Erlangen

Швейцария · 2 центра

• Inselspital — Bern
• CHUV — Lausanne

Публикации

• Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham PMID 27810312
• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurhear PMID 30165437
• Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18. PMID 15492302
• de la Torre Hernandez JM, Hernandez Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left ma PMID 21757111
• Norgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Botker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT PMID 24486266

Идентификаторы

NCT: NCT03820492 · OPTICO-LM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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