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Title: | 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 |
Author: | Rodríguez Leor, Oriol Torre Hernández, José M. 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 |
Keywords: | Assaigs clínics Artèries coronàries Estenosi Clinical trials Coronary arteries Stenosis |
Issue Date: | 9-Aug-2021 |
Publisher: | Publicidad Permanyer, SLU |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.24875/RECICE.M21000227 |
It is part of: | REC: interventional cardiology (English Edition), 2022, vol. 4, num. 1, p. 19-26 |
URI: | http://hdl.handle.net/2445/193132 |
Related resource: | https://doi.org/10.24875/RECICE.M21000227 |
ISSN: | 2604-7322 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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