Clinical trial NCT06272643: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Official title: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Disease
Keywords: Left main coronary artery
Percutaneous coronary intervention
Intravascular ultrasound
Optical coherence tomography
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory)

Brief summary: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Detailed description: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. It is a particularly important site, since it supplies up to 75% of myocardial blood supply, and damage at this level thus implies a large amount of left ventricular myocardium at risk, with a mortality rate close to 40% at 3 years, if revascularisation is not performed.

Anatomically, it has a number of particularities compared to the rest of the coronary arteries, such as its larger diameter (5±0.5 mm) and variable length (10.5±5.3 mm), a composition, particularly at the aorto-ostial level, more similar to the aorta than to the coronary arteries, and in up to 20-30% of the population there is also a division between the anterior descending artery (LAD) and the circumflex artery (LCx) of a third branch called the ramus intermedius or bisector branch.

Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (ICUS or IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location.

Several ICUV studies have attempted to find a minimum luminal area (MLA) as the cut-off point, ranging from 4.5-7.5 mm2, to decide whether to perform revascularisation or not. However, the most commonly used cut-off value is 6 mm2 for various reasons. First, it is correlated with functionally significant values using pressure guidewire. Second, the linear law is applied (assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches). Finally, it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up. Other studies in Asian population have proposed lower cut-off values (4.5 mm2). However, this population has different body size and therefore smaller LMCA size, the study has lower sensitivity (1/4 of patients with area \>4.5 mm2 had positive pressure guidewire), and clinical validation is not presented unlike the LITRE study.

In addition to its value in diagnosis, use of ICUSE allows for optimisation of percutaneous coronary intervention (PCI) if necessary, with decreased events as compared to angiography. Therefore, current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B. In turn, it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions. Thus, in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide.

Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from ICUS. It is an expanding technique. However, its usefulness in LMCA is somewhat more limited, mainly due to the difficult technique of complete filling with contrast and the native area of the ostial segments. Another disadvantage of its use in LMCA is its limited penetration depth (2-3 mm) compared to ICUS (4-8 mm), and since the LMCA usually has diameters of 3.5-4.5 mm, inadequate assessment may occur. In addition, no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. On the other hand, because of the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. There are, however, some correlation studies between ICUS and OCT, both in vivo and in vitro, but not specifically in LMCA. In all these studies, it has been shown that ICUS consistently overestimates OCT measurement by ≈10%, the latter being the closest to the real value. The underuse of this technique in the LCMA is justified by the potential technical problems already mentioned and the lack of a validated MLA cut-off point at this level. The potential prognostic implication of finding, even in patients with functionally nonsignificant lesions, vulnerable plaques or thin-cap fibroatheromas (TCFAs) in OCT has recently been highlighted. The objective is to compare the minimal luminal area by ICUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Patients with intermediate lesion in the LMCA (Left Main Coronary Artery) (25-60% angiographic stenosis by visual estimation) in whom a study with intracoronary imaging technique is considered (at least one pullback with IVUS (Intravascular ultrasound) and OCT (OPTICAL COHERENCE TOMOGRAPHY) from one of the main branches is mandatory).
* Patients able to give informed consent form.

Exclusion Criteria:

* Patients with indication for coronary surgery regardless of significance of LMCA lesion.
* Patients with LMCA lesion showing ulceration, dissection or thrombus.
* Patients with lesion in a previous functioning arterial or venous graft in the territory supplied by the LMCA (protected LMCA).
* Patients with acute coronary syndrome with potentially culpable injury in LMCA.
* Patients unable to give informed consent.
* Patients with ostial LMCA lesion.

Primary outcomes:
measure: To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions
timeFrame: During intervention
Secondary outcomes:
measure: Cardiac Death
timeFrame: 12 months
measure: Cardiovascular Death
timeFrame: 12 months
measure: Acute myocardial infarction of treated/functionally assessed lesion
timeFrame: 12 months
measure: Acute myocardial infarction of any lesion
timeFrame: 12 months
measure: Need for revascularisation of lesion treated/functionally assessed
timeFrame: 12 months
measure: Need for revascularisation of any lesion
timeFrame: 12 months
measure: Secondary efficacy endpoint: Clear Image Length
timeFrame: During intervention
measure: Extend of detectable EEL in LM
timeFrame: During intervention
measure: Correlation between contrast volume used and results, as well as the average contrast volume used in the study.
timeFrame: 30 days after intervention
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitari Dr Balmis
city: Aravaca
country: Spain
facility: Hospital Clinico San Carlos
city: Barcelona
country: Spain
facility: Hospital Universitari Vall Hebron
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de La Frontera
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
Study officials:
References:
citation: Neumann FJ, Sousa-Uva M. 'Ten commandments' for the 2018 ESC/EACTS Guidelines on Myocardial Revascularization. Eur Heart J. 2019 Jan 7;40(2):79-80. doi: 10.1093/eurheartj/ehy855. No abstract available.
citation: 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 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.
citation: Wang Y, Mintz GS, Gu Z, Qi Y, Wang Y, Liu M, Wu X. Meta-analysis and systematic review of intravascular ultrasound versus angiography-guided drug eluting stent implantation in left main coronary disease in 4592 patients. BMC Cardiovasc Disord. 2018 Jun 14;18(1):115. doi: 10.1186/s12872-018-0843-z.
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citation: Kedhi E, Berta B, Roleder T, Hermanides RS, Fabris E, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Al Nooryani A, Rivero F, Malinowski K, De Luca G, Garcia Garcia H, Granada JF, Wojakowski W. Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial. Eur Heart J. 2021 Dec 1;42(45):4671-4679. doi: 10.1093/eurheartj/ehab433.