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. 2024 Jul 4;6(4):278-286.
doi: 10.24875/RECIC.M24000468. eCollection 2024 Oct-Dec.

[Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial]

[Article in Spanish]
Josep Gómez-Lara  1   2 , Ramón López-Palop  3 , Eva Rúmiz  2   4 , Alfonso Jurado-Román  5 , Antonio Gómez-Menchero  6 , José Valencia  7 , Estefanía Fernández  8 , Luis Renier Gonçalves Ramírez  2   9 , Salvatore Brugaletta  10 , Raúl Millán  2   11 , Carlos Cortés  12 , Paula Tejedor  2   13 , Alejando Gutiérrez-Barrios  14 , Xacobe Flores  15 , Ana Belén Cid-Álvarez  2   16 , Sergio García-Blas  17 , Tamara García-Camarero  2   18 , José Antonio Linares Vicente  19 , Beatriz Vaquerizo  20 , Juan Gabriel Córdoba Soriano  21 , Juan Caballero  22 , Rosa María Cardenal Piris  23 , Guillermo Sánchez-Elvira  24 , Loreto Oyarzabal  25 , Alberto Pernigotti  2   26 , Adrià Tramullas  27 , Paula Antuña  28 , Oriol Rodríguez-Leor  29 , Soledad Ojeda  2   30 , Xavier Rossello  10 , Joan-Antoni Gómez-Hospital  1 , Javier Bermejo  2   31 , Héctor M García-García  32 , Armando Pérez de Prado  9 , Enrique Gutiérrez-Ibañes  31   2
Affiliations

[Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial]

[Article in Spanish]
Josep Gómez-Lara et al. REC Interv Cardiol. .

Abstract

Introduction and objectives:: The optimal treatment of nonculprit angiographic intermediate lesions (diameter stenosis 40%-69%) in patients with ST-segment elevation myocardial infarction (STEMI) is still unknown. Lesions with fractional flow reserve (FFR) ≤ 0.80 are indicative of ischemia and benefit from revascularization. However, lesions with FFR > 0.80 and optical coherence tomography (OCT) findings of vulnerability have been hypothesized to cause adverse events during follow-up. The study aims to compare the efficacy of a preventive treatment with stent implantation plus optimal medical therapy vs optimal medical therapy alone for nonculprit intermediate lesions with FFR > 0.80 and OCT findings of plaque vulnerability in STEMI patients at 4 years of follow-up.

Methods:: This parallel-group, multicenter, controlled, single-blind, and 1:1 randomized trial will enroll a total of 600 STEMI patients with ≥ 1 intermediate nonculprit lesions with FFR > 0.80 and OCT findings of plaque vulnerability. The primary endpoint is target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. The study will include a parallel registry of patients with FFR > 0.80 but without OCT findings of vulnerability. Vulnerable plaques are defined as lipid-rich fibroathermas with plaque burden ≥ 70% and a thin fibrous cap (≤ 80 mm).

Results:: The VULNERABLE trial will reveal the role of preventive treatment with stent implantation for nonculprit and functionally nonsignificant vulnerable plaques in STEMI patients.

Conclusions:: This is the first randomized trial of OCT-guided treatment of vulnerables plaques. Registered at ClinicalTrials.gov (NCT05599061).

Keywords: Fractional flow reserve; Optical coherence tomography; ST-segment elevation myocardial infarction; Vulnerable plaque.

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Conflict of interest statement

CONFLICTO DE INTERESES: J. Gómez-Lara y E. Gutiérrez-Ibañes han recibido una beca de Abbott Vascular para la realización de este estudio. A. Jurado- Román ha recibido honorarios de Abbott, Boston y Shockwave. E. Fernández ha recibido honorarios de Abbott y Hexacath. C. Cortés ha recibido un Contrato Río Hortega del Instituto de Salud Carlos III. S. Brugaletta ha recibido honorarios de Abbott, Microport y General Electric. T. García-Camarero ha recibido honorarios de Medtronic y Boston. J.A. Linares Vicente ha recibido honorarios de Abbott Vascular, Braun, AstraZeneca, Bayer y IZASA. O. Rodríguez-Leor ha recibido honorarios de Shockwave, WorlsMedica y Medtronic. S. Ojeda ha recibido honorarios de Abbott, Boston, WorldMedica y Biosensors. A. Pérez de Prado ha recibido becas y honorarios de Abbot, Boston, iVascular y Terumo. H.M. García-García ha recibido honorarios de ACIST, Boston Scientific, Medis, Biotronik, InfraRedx/Nipro, Chiesi y Cordis. S. Ojeda y A. Pérez de Prado son editores asociados de REC: Interventional Cardiology; se ha seguido el procedimiento editorial establecido en la revista para garantizar la gestión imparcial del manuscrito. El resto de los autores no presentan conflictos de intereses.

Figures

Figure 1
Figure 1. Study diagram. FFR, fractional flow reserve; OCT, optical coherence tomography; OMT, optimal medical treatment; PCI, percutaneous coronary intervention; STEMI, ST-segment elevation myocardial infarction.
Figure 2
Figure 2. Vulnerable plaque criteria by optical coherence tomography. EEM, external elastic membrane; minimal lumen area.
Figure 3
Figure 3. Distinction between vulnerable plaques and other findings by optical coherence tomography (OCT). A: plaque with superficial calcium (hypointense core with well-defined margins that do not attenuate the passage of light; arrow) and a thin fibrous cap. B: calcified nodule (arrow) protruding into the lumen and attenuating the signal, despite being composed of calcium. C: tangential signal loss (arrow) due to insufficient light beams caused by the peripheral, noncentral position of the OCT probe. D: superficial accumulation of macrophages (arrow) with a hyperintense appearance relative to the adjacent intima, with signal attenuation behind. E: presence of blood in the lumen due to inadequate flushing (arrow) during image acquisition, which distorts the arterial wall image, creating the appearance of hypointense regions. F: presence of blood between the probe and the OCT catheter (arrow) due to inadequate flushing, which distorts the arterial wall image and mimics hypointense regions.
Figure 4
Figure 4. Plaque burden assessment by optical coherence tomography. A: cross-section of the minimal lumen area. B: cross-section where the external elastic membrane (EEM) was measured. Since the EEM cannot usually be assessed in the cross-section corresponding to the MLA, an approximate estimation is made by measuring the EEM within 10 mm proximal or distal to the MLA (preferably distal) in the absence of side branches. The EEM will be assessed in the first cross-section where 60% of the EEM perimeter can be evaluated.
Figura 1
Figura 1. Diagrama del estudio. IAMCEST: infarto agudo de miocardio con elevación del segmento ST; ICP: intervencionismo coronario percutáneo; OCT: tomografía de coherencia óptica; RFF: reserva fraccional de flujo; TMO: tratamiento médico óptimo.
Figura 2
Figura 2. Criterios de placa vulnerable por tomografía de coherencia óptica. ALM: área luminal mínima; MEE: membrana elástica externa.
Figura 3
Figura 3. Diferenciación entre placas vulnerables y otros hallazgos por tomografía de coherencia óptica (OCT). A: placa con calcio superficial (núcleo hipointenso de bordes bien definidos que no atenúa el paso de luz; flecha) con una capa fibrosa fina. B: nódulo calcificado (flecha) con protrusión dentro del lumen y atenuación de la señal a pesar de tratarse de calcio. C: pérdida de señal tangencial (flecha) por falta de haces de luz por una posición periférica, no central, de la sonda de OCT. D: acúmulo superficial de macrófagos (flecha) con imagen hiperintensa, respecto a la íntima adyacente, con atenuación de la señal detrás. E: presencia de sangre en el lumen debido a un mal lavado (flecha) durante la adquisición que distorsiona la imagen de la pared arterial simulando regiones hipointensas. F: presencia de sangre entre la sonda y el catéter de OCT (flecha) debido a un mal purgado que distorsiona la imagen de la pared arterial simulando regiones hipointensas.
Figura 4
Figura 4. Valoración de la carga de placa por tomografía de coherencia óptica. A: sección del área luminal mínima (ALM). B: sección donde se ha medido la membrana elástica externa (MEE). Dado que la MEE no se puede valorar habitualmente en la sección transversal correspondiente al ALM, se hace una estimación aproximada midiendo la MEE dentro de los 10 mm proximales o distales al ALM (preferiblemente distales en ausencia de ramas laterales). Se valorará la MEE en la primera sección transversal donde se pueda evaluar un 60% del perímetro de la MEE.
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