Justificación y diseño del estudio Concordancia entre RFF e iFR en lesiones del tronco común.Estudio iLITRO-EPIC-07

1. Oriol Rodríguez-Leor ¹
2. José M. de la Torre Hernández ²
3. Tamara García-Camarero ²
4. Ramón López Palop ³
5. Bruno García del Blanco ⁴
6. Xavier Carrillo ¹
7. Juan Jose Portero Portaz ⁵
8. Marcelo Jiménez Kockar ⁶
9. Josep Gómez Lara ⁷
10. Soledad Ojeda ⁸
11. Fernando Alfonso ⁹
12. Salvatore Brugaletta ¹⁰
13. Ana M. Planas del Viejo ¹¹
14. Jose Antonio Linares Vicente ¹²
15. Agustín Fernández Cisnal ¹³
16. Beatriz Vaquerizo Montilla ¹⁴
17. Francisco Fernández-Salinas ¹⁵
18. José Francisco Díaz Fernández ¹⁶
19. Juan Carlos Rama Merchán ¹⁷
20. Eduardo Molina Navarro ¹⁸
21. Erika Muñoz García ¹⁹
22. Francisco José Morales Ponce ²⁰
23. R. Trillo Nouche ²¹
24. Miren Telleria Arrieta ²²
25. Juan Rondán ²³
26. Pablo Avanzas Fernández ²⁴
27. José Moreu ²⁵
28. José A. Baz Alonso ²⁶
29. Felipe Hernández Hernández ²⁷
30. Javier Escaned ²⁸
31. J.M. Sanchís García ¹³
32. Fernando Lozano ²⁹
33. Beatriz Toledano ³⁰
34. Puigfel ³¹
35. Mario Sadaba ³²
36. Armando Pérez de Prado ³³
37. Mostrar todos os autores +

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DOI: 10.24875/RECIC.M21000223 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

Outras publicacións en: REC: Interventional Cardiology

Resumo

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).

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