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

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 μm). 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).

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Publication Details

Journal
REC interventional cardiology (English Edition)
Published
2024-10-23
DOI
https://doi.org/10.24875/recice.m24000468
Citations
3
Primary Topic
Coronary Interventions and Diagnostics
Type
article
Field-Weighted Citation Impact
1.72
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article

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

Soledad Ojeda, Rosa M. Cardenal Piris, Xacobe Flores‐Ríos, Ana Belén Cid-Álvarez et al.
3 citations
REC interventional cardiology (English Edition)
Coronary Interventions and Diagnostics
1.72
article

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

Soledad Ojeda, Rosa M. Cardenal Piris, Xacobe Flores‐Ríos, Ana Belén Cid-Álvarez, Oriol Rodríguez‐Leor, Estefanía Fernández, Josep Gómez-Lara, Eva Rúmiz, J. A. Caballero, José Valencia, Xavier Rosselló, Guillermo Sánchez-Elvira, Alfonso Jurado-Román, Juan Gabriel Córdoba Soriano, Beatriz Vaquerizo, Carlos Cortés, Loreto Oyarzabal, Ramón López‐Palop, Sergio García‐Blas, Salvatore Brugaletta, Tamara García Camarero, Héctor M. García‐García, Antonio Gómez‐Menchero, Javier Bermejo, Armando Pérez de Prado, Alberto Pernigotti, Paula Tejedor, Paula Antuña, Adrià Tramullas, Alejando Gutiérrez-Barrios, José Antonio Linares Vicente, Raúl Millán, Luis Renier Goncalves Ramírez, and Enrique Gutiérrez-Ibañes
article en
3 citations

Abstract

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 μm). 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).

REC interventional cardiology (English Edition)
Openalex Percentile: Top 15%
Coronary Interventions and Diagnostics
1.72
DOIOpen Access PDFOpenAlex
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