Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design
Por:
Sanchis, J, Ariza-Sole, A, Abu-Assi, E, Alegre, O, Alfonso, F, Barrabes, JA, Baz, JA, Carol, A, Villanueva, PD, del Blanco, BG, Elizaga, J, Fernandez, E, del Egido, AG, Picard, JG, Blazquez, IG, Hospital, JAG, Hernandez-Antolin, R, Llibre, C, Marin, F, Sanchez, DM, Martin, R, Selles, MM, Minana, G, Gallardo, MJM, Nunez, J, de Prado, AP, Pinar, E, Sanmartin, M, Sionis, A, Villa, A, Marrugat, J, Bueno, H
Publicada:
1 feb 2019
Resumen:
Introduction and objectives: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI.
Methods: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age >= 70 years, and frailty defined by a category >= 4 in the Clinical Frailty Scale. Participants will be randomized to an invasive (coronary angiogram and revascularization if anatomically amenable) or conservative (medical treatment and coronary angiogram only if persistent clinical instability) strategy. The primary endpoint will be the number of days alive out of hospital during the first year. The coprimary endpoint will be the time until the first cardiac event (cardiac death, reinfarction or postdischarge revascularization). We estimate a sample size of 178 patients (89 per arm), considering an increase of 20% in the proportion of days alive out of hospital with the invasive management.
Results: The results of this study will add important knowledge to inform the management of frail elderly patients hospitalized with NSTEMI.
Conclusions: We hypothesize that the invasive strategy will improve outcomes in frail elderly patients with NSTEMI. If this is confirmed, frailty status should not dissuade physicians from implementing an invasive management strategy. (C) 2018 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.
Filiaciones:
Sanchis, J:
Univ Valencia, CIBERCV, INCLIVA, Serv Cardiol,Hosp Clin Univ Valencia, Valencia, Spain
Ariza-Sole, A:
Hosp Bellvitge Princeps Espanya, Serv Cardiol, Barcelona, Spain
Abu-Assi, E:
Hosp Alvaro Cunqueiro, Serv Cardiol, Vigo, Pontevedra, Spain
Alegre, O:
Hosp Bellvitge Princeps Espanya, Serv Cardiol, Barcelona, Spain
Alfonso, F:
Hosp Univ La Princesa, Serv Cardiol, Madrid, Spain
Barrabes, JA:
Hosp Univ Vall dHebron, CIBERCV, Serv Cardiol, Barcelona, Spain
Baz, JA:
Hosp Alvaro Cunqueiro, Serv Cardiol, Vigo, Pontevedra, Spain
Carol, A:
Hosp Moises Broggi, Serv Cardiol, Barcelona, Spain
Villanueva, PD:
Hosp Univ La Princesa, Serv Cardiol, Madrid, Spain
del Blanco, BG:
Hosp Univ Vall dHebron, CIBERCV, Serv Cardiol, Barcelona, Spain
Elizaga, J:
Univ Europea, Univ Complutense, Serv Cardiol, Hosp Univ Gregorio Maranon,CIBERCV, Madrid, Spain
Fernandez, E:
Hosp Badalona Germans Trias & Pujol, CIBERCV, Serv Cardiol, Barcelona, Spain
del Egido, AG:
Hosp Leon, CIBERCV, Leon, Spain
Picard, JG:
Hosp Santa Creu & Sant Pau, CIBERCV, Serv Cardiol, Barcelona, Spain
Blazquez, IG:
Hosp 12 Octubre, Serv Cardiol, Madrid, Spain
Hospital, JAG:
Hosp Bellvitge Princeps Espanya, Serv Cardiol, Barcelona, Spain
Hernandez-Antolin, R:
Hosp Ramon & Cajal, Serv Cardiol, CIBERCV, Madrid, Spain
Llibre, C:
Hosp Badalona Germans Trias & Pujol, CIBERCV, Serv Cardiol, Barcelona, Spain
Marin, F:
Hosp Virgen Arrixaca, Serv Cardiol, CIBERCV, Murcia, Spain
Sanchez, DM:
Hosp Cent Def, Serv Cardiol, Madrid, Spain
Martin, R:
Hosp 12 Octubre, Serv Cardiol, Madrid, Spain
Selles, MM:
Univ Europea, Univ Complutense, Serv Cardiol, Hosp Univ Gregorio Maranon,CIBERCV, Madrid, Spain
Minana, G:
Univ Valencia, CIBERCV, INCLIVA, Serv Cardiol,Hosp Clin Univ Valencia, Valencia, Spain
Gallardo, MJM:
Hosp Cent Def, Serv Cardiol, Madrid, Spain
Nunez, J:
Univ Valencia, CIBERCV, INCLIVA, Serv Cardiol,Hosp Clin Univ Valencia, Valencia, Spain
de Prado, AP:
Hosp Leon, CIBERCV, Leon, Spain
Pinar, E:
Hosp Virgen Arrixaca, Serv Cardiol, CIBERCV, Murcia, Spain
Sanmartin, M:
Hosp Ramon & Cajal, Serv Cardiol, CIBERCV, Madrid, Spain
Sionis, A:
Hosp Santa Creu & Sant Pau, CIBERCV, Serv Cardiol, Barcelona, Spain
Villa, A:
Hosp Univ Sureste, Serv Cardiol, Madrid, Spain
Marrugat, J:
Inst Hosp Mar Invest Med IMIM, CIBERCV, Grp Epidemiol & Genet Cardiovasc, Barcelona, Spain
Bueno, H:
Hosp 12 Octubre, Serv Cardiol, Madrid, Spain
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