OPTICO-LM: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Patient with left-main stenosis Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT |
Diagnostic Test: 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
|
Outcome Measures
Primary Outcome Measures
- OCT vs. FFR [Measurement at Procedure/ Baseline Visit]
- The area under the curve of OCT-derived MLA for FFR≤0.8
- OCT vs. FFR [Measurement at Procedure/ Baseline Visit]
-The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8
- FFRCT vs. FFR [Measurement at Procedure/ Baseline Visit]
Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8
Secondary Outcome Measures
- OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR [Measurement at Procedure/ Baseline Visit]
- The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
- OCT vs. FFR, RFR, resting Pd/Pa, FFRCT [Measurement at Procedure/ Baseline Visit]
- Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
- OCT vs. FFR, RFR, resting Pd/Pa, FFRCT [Measurement at Procedure/ Baseline Visit]
- Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR
- OCT vs. CTA [Measurement at Procedure/ Baseline Visit]
- Correlation between luminal diameter stenosis of CTA and OCT-derived MLA
- OCT vs. CTA [Measurement at Procedure/ Baseline Visit]
- Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.
- Clinical endpoint at 1 year [12 Month]
Death
- Clinical endpoint at 1 year [12 Month]
Myocardial infarction
- Clinical endpoint at 1 year [12 Month]
Target vessel myocardial infarction
- Clinical endpoint at 1 year [12 Month]
Target lesion revascularization
- Clinical endpoint at 1 year [12 Month]
Target vessel revascularization
- Clinical endpoint at 1 year [12 Month]
Any revascularization
- Clinical endpoint at 1 year [12 Month]
Stent thrombosis
- Clinical endpoint at 1 year [12 Month]
Stroke and transient ischemic attack
- Clinical endpoint at 1 year [12 Month]
Acute renal failure
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Age ≥18 years.
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Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.
Exclusion Criteria:
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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])
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Ostial LM disease.
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Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
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LM In-stent restenosis.
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Previous coronary stenting of the left coronary system.
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Chronic total occlusion.
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Previous coronary artery bypass graft.
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Previous MI related to the left coronary artery.
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Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
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The presence of hemodynamic instability.
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Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
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Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
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Life expectancy less than 1 year.
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Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
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Body mass index >35kg/m2.
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Complex congenital heart disease other than anomalous coronary origins alone.
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Ventricular septal defect.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | France | 63000 | |
| 2 | Institute Mutualiste Montsouris | Paris | France | 75014 | |
| 3 | Centre Cardiologique du Nord | Saint-Denis | France | 75014 | |
| 4 | Universitätsklinikum Giessen Justus-Liebig Universität | Gießen | Hesse | Germany | 35392 |
| 5 | Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie | Erlangen | Germany | 91054 | |
| 6 | Ageo Central General Hospital | Ageo | Japan | 362-8588 | |
| 7 | Gifu heart center | Gifu | Japan | 500-8384 | |
| 8 | Department of Cardiovascular Medicine Shinshu University School of Medicine | Nagano | Japan | 390-8621 | |
| 9 | Kansai Medical University, | Osaka | Japan | 573-1010 | |
| 10 | Medical Corporation Ouyuukai Tokorozawa Heart Center | Saitama | Japan | 359-1142 | |
| 11 | Sapporo Higashi Tokushukai Hospital | Sapporo | Japan | 065-0033 | |
| 12 | Inselspital | Bern | Switzerland | 3010 | |
| 13 | CHUV | Lausanne | Switzerland | 1011 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Lorenz Raeber, Prof. MD PhD, Inselspital
Study Documents (Full-Text)
None provided.More Information
Publications
- de la Torre Hernandez JM, Hernández 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 main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.
- 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. Epub 2004 Oct 18.
- Mäkikallio 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, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum in: Lancet. 2016 Dec 3;388(10061):2742.
- Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni 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/eurheartj/ehy394. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096.
- Nørgaard 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, Bøtker 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 trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.
- OPTICO-LM