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05_recic_21_027_rodriguez_ao_uktrad.pdf (314.61 KB)

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2021-08-09

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cc by-nc-nd (c) Rodríguez Leor, Oriol et al., 2021
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/193132

Rationale and design of the Concordance study between FFR and iFR for the assessment of lesions in the left main coronary artery. The ILITRO-EPIC-07 Trial

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https://doi.org/10.24875/RECICE.M21000227

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Introduction and objectives: Patients with left main coronary artery (LMCA) stenosis have been excluded from the trials that support the non-inferiority of the instantaneous wave-free ratio (iFR) compared to the fractional flow reserve (FFR) in the decision-making process of coronary revascularization. This study proposes to prospectively assess the concordance between the two indices in LMCA lesions and to validate the iFR cut-off value of 0.89 for clinical use. Methods: National, prospective, and observational multicenter registry of 300 consecutive patients with intermediate lesions in the LMCA (angiographic stenosis, 25% to 60%. A pressure gudiewire study and determination of the RFF and the iFR will be performed: in the event of a negative concordant result (FFR > 0.80/iFR > 0.89), no treatment will be performed; in case of a positive concordant result (FFR <= 0.80/iFR <= 0.89), revascularization will be performed; In the event of a discordant result (FFR> 0.80/iFR <= 0.89 or FFR <= 0.80/iFR> 0.89), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm(2). The primary clinical endpoint will be a composite of cardiovascular death, LMCA lesion-related non-fatal infarction or need for revascularization of the LMCA lesion at 12 months. Conclusions: Confirm that an iFR-guided decision-making process in patients with intermediate LMCA stenosis is clinically safe and would have a significant clinical impact. Also, justify its systematic use when prescribing treatment in these potentially high-risk patients.

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Assaigs clínics, Artèries coronàries, Estenosi

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Clinical trials, Coronary arteries, Stenosis

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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RODRÍGUEZ LEOR, Oriol, TORRE HERNÁNDEZ, José maría de la, GARCÍA CAMARERO, Tamara, LÓPEZ PALOP, Ramón, GARCÍA DEL BLANCO, Bruno, CARRILLO, Xavier, PORTERO PORTAZ, Juan josé, JIMÉNEZ KOCKAR, Marcelo, GÓMEZ LARA, Josep, OJEDA, Soledad, ALFONSO, Fernando, BRUGALETTA, Salvatore, PLANAS DEL VIEJO, Ana, LINARES, José antonio, FERNÁNDEZ CISNAL, Agustín, VAQUERIZO, Beatriz, FERNÁNDEZ SALINAS, Francisco, DÍAZ FERNÁNDEZ, José francisco, RAMA MERCHÁN, Juan carlos, MOLINA, Eduardo, MUÑOZ GARCÍA, Érika, MORALES, Francisco, TRILLO, Ramiro, TELLERÍA, Miren, RONDÁN, Juan, AVANZAS, Pablo, MOREU, José, BAZ ALONSO, José antonio, HERNÁNDEZ, Felipe, ESCANED, Javier, SANCHIS, Juan, LOZANO, Fernando, TOLEDANO, Beatriz, PUIGFEL, Martí, SÁDABA, Mario, PÉREZ DE PRADO, Armando. Rationale and design of the Concordance study between FFR and iFR for the assessment of lesions in the left main coronary artery. The ILITRO-EPIC-07 Trial. _REC: interventional cardiology (English Edition)_. 2022. Vol. 4, núm. 1, pàgs. 19-26. [consulta: 25 de gener de 2026]. ISSN: 2604-7322. [Disponible a: https://hdl.handle.net/2445/193132]

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