Justificación y diseño del estudio Concordancia entre RFF e iFR en lesiones del tronco común.Estudio iLITRO-EPIC-07
- Oriol Rodríguez-Leor 1
- José M. de la Torre Hernández 2
- Tamara García-Camarero 2
- Ramón López Palop 3
- Bruno García del Blanco 4
- Xavier Carrillo 5
- Juan Jose Portero Portaz 6
- Marcelo Jiménez Kockar 7
- Josep Gómez Lara 8
- Soledad Ojeda 9
- Fernando Alfonso 10
- Salvatore Brugaletta 11
- Ana M. Planas del Viejo 12
- Jose Antonio Linares Vicente 13
- Agustín Fernández Cisnal 14
- Beatriz Vaquerizo Montilla 15
- Francisco Fernández-Salinas 16
- José Francisco Díaz Fernández 17
- Juan Carlos Rama Merchán 18
- Eduardo Molina Navarro 19
- Erika Muñoz García 20
- Francisco José Morales Ponce 21
- R. Trillo Nouche 22
- Miren Telleria Arrieta 23
- Juan Rondán 24
- Pablo Avanzas Fernández 25
- José Moreu 26
- José A. Baz Alonso 27
- Felipe Hernández Hernández 28
- Javier Escaned 29
- J.M. Sanchís García 14
- Fernando Lozano 30
- Beatriz Toledano 31
- Puigfel 32
- Mario Sadaba 33
- Armando Pérez de Prado 34
- Erakutsi egile guztiak +
- 1 Institut del Cor-ICOR, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España
- 2 Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, España
- 3 Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, España
- 4 Servicio de Cardiología, Hospital Universitari Vall d’Hebron, Barcelona, España
- 5 nstitut del Cor-ICOR, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España
- 6 Servicio de Cardiología, Hospital General Universitario de Albacete, Albacete, España
- 7 Servei de Cardiologia, Hospital de la Santa Creu i Sant Pau, Barcelona, España
- 8 Servei de Cardiologia, Hospital Universitari de Bellvitge, IDIBELL, L’Hospitalet de Llobregat, Barcelona, España
- 9 Servicio de Cardiología, Hospital Reina Sofía, Córdoba, España
- 10 Servicio de Cardiología, Hospital de la Princesa, Madrid, España
- 11 Servei de Cardiologia, Hospital Clínic de Barcelona, Barcelona, España
- 12 Servicio de Cardiología, Hospital General Universitario de Castellón, Castellón de la Plana, Castellón, España
- 13 Servicio de Cardiología, Hospital Clínico Universitario Lozano Blesa, Zaragoza, España
- 14 Servicio de Cardiología, Hospital Clínic de València, Universitat de València, València, España
- 15 Servei de Cardiologia, Hospital del Mar, Barcelona, España
- 16 Servei de Cardiologia, Hospital Universitari Joan XXII, Tarragona, España
- 17 Servicio de Cardiología, Hospital General Juan Ramón Jiménez, Huelva, España
- 18 Servicio de Cardiología, Hospital de Mérida, Mérida, Badajoz, España
- 19 Servicio de Cardiología, Hospital Universitario Virgen de las Nieves, Granada, España
- 20 Servicio de Cardiología, Hospital Universitario Virgen de la Victoria, Málaga, España
- 21 Servicio de Cardiología, Hospital Universitario de Puerto Real, Puerto Real, Cádiz, España
- 22 Servicio de Cardiología, Hospital Clínico Universitario de Santiago, Santiago de Compostela, A Coruña, España
- 23 Servicio de Cardiología, Hospital Universitario de Donostia, Donostia, Gipuzkoa, España
- 24 Servicio de Cardiología, Hospital de Cabueñes, Gijón, Asturias, España
- 25 Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Asturias, España
- 26 Servicio de Cardiología, Hospital Virgen de la Salud, Toledo, España
- 27 Servicio de Cardiología, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, España
- 28 Servicio de Cardiología, Clínica Universitaria de Navarra, Madrid, España
- 29 Hospital Clínico San Carlos IDISSC, Universidad Complutense de Madrid, Madrid, España
- 30 Servicio de Cardiología, Hospital General de Ciudad Real, Ciudad Real, España
- 31 Servei de Cardiologia, Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
- 32 Servei de Cardiologia, Hospital Universitari de Girona Josep Trueta, Girona, España
- 33 Servicio de Cardiología, Hospital de Galdakao-Usansolo, Galdakao, Bizkaia, España
- 34 Servicio de Cardiología, Hospital de León, León, España
ISSN: 2604-7276, 2604-7306
Argitalpen urtea: 2022
Alea: 4
Zenbakia: 1
Orrialdeak: 19-26
Mota: Artikulua
Beste argitalpen batzuk: REC: Interventional Cardiology
Laburpena
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).
Erreferentzia bibliografikoak
- 1. Lindstaedt M, Spiecker M, Perings C, et al. How good are experienced interventional cardiologist at predicting the functional significance of intermediate or equivocal left main coronary stenosis? Int J Cardiol. 2007;120:254-261.
- 2. Windecker S, Kohl P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J. 2014;35:2541-2619.
- 3. Pijls NH, van Schaardenburgh P, Manoharan G, et al. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007;49:2105-2111.
- 4. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve vs. angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360:213-224.
- 5. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve-guided PCI vs. medical therapy in stable coronary disease. N Engl J Med. 2012;367:991-1001.
- 6. Hamilos M, Muller O, Cuisset T, et al. Long-term clinical outcome after fractional flow reserve-guided treatment in patients with angiographically equivocal left main coronary artery stenosis. Circulation. 2009;120:1505-1512.
- 7. Sen S, Escaned J, Malik IS, et al. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012;59:1392-1402.
- 8. Davies JE, Sen S, Dehbi HM, et al. Use of the instantaneous wave-free ratio or fractional flow reserve in PCI. N Engl J Med. 2017;376:1824-1834.
- 9. Götberg M, Christiansen EH, Gudmundsdottir IJ, et al. iFRSWEDEHEART Investigators. Instantaneous free-wave ratio versus fractional flow reserve to guide PCI. N Engl J Med. 2017;376:1813-1823.
- 10. Warisawa T, Cook CM, Rajkumar C, et al. Safety of Revascularization Deferral of Left Main Stenosis Based on Instantaneous Wave-Free Ratio Evaluation. JACC Cardiovasc Interv. 2020;13:1655-1664.
- 11. Kobayashi Y, Johnoson NP, Berry C, et al. The influence of lesion location on the diagnostic accuracy of adenosine-free coronary pressure wire measurements. J Am Coll Cardiol Interv. 2016;9:2390-2399.
- 12. de la Torre Hernandez JM, Hernandez F, Alfonso F, et al. Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011;58:351-358.
- 13. Nair PK, Marroquin OC, Mulukutla SR, et al. Clinical utility of regadenoson for assessing fractional flow reserve. JACC Cardiovasc Interv. 2011;1085-1092.
- 14. Ragosta M, Dee S, Sarembock IJ, et al. Prevalence of unfavorable angiographic characteristics for percutaneous intervention in patients with unprotected left main coronary artery disease. Catheter Cardiovasc Interv. 2006;68:357-362.
- 15. Cameron A, Kemp HG Jr, Fisher LD, et al. Left main coronary artery stenosis: angiographic determination. Circulation. 1983;68:484-489.
- 16. Fisher LD, Judkins MP, Lesperance J, et al. Reproducibility of coronary arteriographic reading in the coronary artery study (CASS). Catheter Cardiovasc Diagn. 1982;8:565-575.
- 17. Arnett EN, Isner JM, Redwood DR, et al. Coronary artery narrowing in coronary heart disease: comparison of cineangiographic and necropsy findings. Ann Intern Med. 1979;91:350-356.
- 18. Lenzen MJ, Boersma E, Bertrand ME, et al. Management and outcome of patients with established coronary artery disease: the Euro Heart Survey on coronary revascularization. Eur Heart J. 2005;26:1169-1179.
- 19. Kandzari DE, Colombo A, Park SJ, et al. Revascularization for unprotected left main disease: evolution of the evidence basis to redefine treatments standards. J Am Coll Cardiol. 2009;54:1576-1588.
- 20. Botman CJ, Schonberger J, Koolen S, et al. Does stenosis severity of native vessels influence bypass graft patency? A prospective FFR-guided study. Ann Thorac Surg. 2007;83:2093-2097.
- 21. Mallidi J, Atreya AR, Cook J, et al. Long term outcomes following fractional flow reserve guided treatment of angiographically ambiguous left main coronary artery disease: a meta-analysis of prospective cohort studies. Catheter Cardiovasc Interv. 2015;86:12-18.
- 22. Petraco R, van de Hoef TP, Nijjer S, et al. Baseline instantaneous wave-free ratio as a pressure-only estimation of underlying coronary flow reserve: results of the JUSTIFY-CFR Study (Joined Coronary Pressure and Flow Analysis to Determine Diagnostic Characteristics of Basal and Hyperemic Indices of Functional Lesion Severity Coronary Flow Reserve). Circ Cardiovasc Interv. 2014;7:492-502.
- 23. Nijjer SS, de Waard GA, Sen S, et al. Coronary pressure and flow relationships in humans: phasic analysis of normal and pathological vessels and the implications for stenosis assessment: a report from the Iberian-Dutch-English (IDEAL) collaborators. Eur Heart J. 2016;37:2069-2080.
- 24. Lee JM, Shin ES, Nam CW, et al. Clinical outcomes according to fractional flow reserve or instantaneous wave-free ratio in deferred lesions. JACC Cardiovasc Interv. 2017;10:2502-2510.