Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial
Year: 2024
Type: article
Study design: Study Protocol
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).
Authors: Josep Gómez-Lara, Ramón López-Palop, Eva Rúmiz, Alfonso Jurado-Román, Antonio Gómez-Menchero, José Valencia, Estefanía Fernández, Luis Renier Goncalves Ramírez, Salvatore Brugaletta, Raúl Millán, Carlos Cortés, Paula Tejedor, Alejando Gutiérrez-Barrios, Xacobe Flores, Ana Belén Cid-Álvarez, Sergio García-Blas, Tamara García-Camarero, José Antonio Linares Vicente, Beatriz Vaquerizo, Juan Gabriel Córdoba Soriano, Juan Caballero, Rosa María Cardenal Piris, Guillermo Sánchez-Elvira, Loreto Oyarzabal, Alberto Pernigotti, Adrià Tramullas, Paula Antuña, Oriol Rodríguez-Leor, Soledad Ojeda, Xavier Rossello, Javier Bermejo, Héctor M. García-García, Armando Pérez de Prado, and Enrique Gutiérrez-Ibañes
Institutions: Bellvitge University Hospital, Institut d'Investigació Biomédica de Bellvitge, Centro de Investigación en Red en Enfermedades Cardiovasculares, Centro de Investigación Biomédica en Red, Hospital Universitario Virgen de la Arrixaca, Hospital General Universitario De Valencia, Hospital Universitario La Paz, Hospital Juan Ramón Jiménez, Hospital General Universitario de Alicante Doctor Balmis, Hospital de Sant Pau, Hospital Universitario de León, Complejo Asistencial Universitario de León, Hospital Clínic de Barcelona, Health Research Institute of the Balearic Islands, Hospital Universitario Son Espases, Hospital Clínico Universitario de Valladolid, Hospital General Universitario de Elche, Hospital Universitario Puerta del Mar, Complexo Hospitalario Universitario A Coruña, Complejo Hospitalario Universitario de Santiago, Hospital Clínico Universitario de Valencia, Marqués de Valdecilla University Hospital, Hospital Clínico Universitario Lozano Blesa, Hospital Del Mar, Hospital General Universitario de Albacete, Complejo Hospitalario Universitario de Albacete, Hospital Universitario Virgen del Rocío, Hospital Universitari de Girona Doctor Josep Trueta, Hospital Universitari Joan XXIII de Tarragona, Donostiako Unibertsitate Ospitalea, Hospital Universitario Central de Asturias, Hospital Universitari Germans Trias i Pujol, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, University of Córdoba, Universidad Complutense de Madrid, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, MedStar Washington Hospital Center
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4403690765