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
| Autor: | José M. de la Torre-Hernández, José Moreu, Agustín Fernández-Cisnal, Juan Carlos Rama-Merchán, Oriol Rodríguez-Leor, Ana Planas del Viejo, Josep Gómez-Lara, Miren Telleria, Tamara García-Camarero, José Francisco Díaz-Fernández, Juan J Portero-Portaz, Fernando Lozano, José Antonio Baz-Alonso, Jose A. Linares, Ramiro Trillo, Fernando Alfonso, Beatriz Vaquerizo, Xavier Carrillo, and Mario Sádaba, Francisco Fernández-Salinas, Bruno García del Blanco, Martí Puigfel, Francisco J. Morales, Soledad Ojeda, Marcelo Jimenez-Kockar, Javier Escaned, Armando Pérez de Prado, Juan Rondan, Salvatore Brugaletta, Pablo Avanzas, Juan Sanchis, Beatriz Toledano, Felipe Hernández, Ramón López-Palop, Eduardo Molina, Erika Muñoz-García |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Stenosis
medicine.medical_specialty business.industry Concordance iFR Left main coronary artery EPIC FFR Coronary arteries medicine.anatomical_structure Clinical trials Internal medicine Cardiology medicine Medicine Cardiology and Cardiovascular Medicine business Estenosi Artèries coronàries Artery Assaigs clínics |
| Zdroj: | REC: Interventional Cardiology (English Ed.), Vol 4, Iss 1, Pp 19-26 (2022) |
| ISSN: | 2604-7322 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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