Find in Library
Search millions of books, articles, and more
Indexed Open Access Databases
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
oleh: Oriol Rodríguez-Leor, José M. de la Torre-Hernández, Tamara García-Camarero, Ramón López-Palop, Bruno García del Blanco, Xavier Carrillo, Juan José Portero-Portaz, Marcelo Jiménez-Kockar, Josep Gómez-Lara, Soledad Ojeda, Fernando Alfonso, Salvatore Brugaletta, Ana Planas del Viejo, José Antonio Linares, Agustín Fernández-Cisnal, Beatriz Vaquerizo, Francisco Fernández-Salinas, José Francisco Díaz-Fernández, Juan Carlos Rama-Merchán, Eduardo Molina, Érika Muñoz-García, Francisco Morales, Ramiro Trillo, Miren Tellería, Juan Rondán, Pablo Avanzas, José Moreu, José Antonio Baz-Alonso, Felipe Hernández, Javier Escaned, Juan Sanchis, Fernando Lozano, Beatriz Toledano, Martí Puigfel, Mario Sádaba, Armando Pérez de Prado
Format: | Article |
---|---|
Diterbitkan: | Permanyer 2022-02-01 |
Deskripsi
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 mm2. 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. Registered at ClinicalTrials.gov ( Identifier: NCT03767621).