Juan Sanchis1, Albert Ariza-Solé2, Emad Abu-Assi3, Oriol Alegre2, Fernando Alfonso4, José Antonio Barrabés5, José Antonio Baz3, Antonio Carol6, Pablo Díez Villanueva4, Bruno García Del Blanco5, Jaime Elízaga7, Eduard Fernandez8, Abel García Del Egido9, Joan García Picard10, Iván Gómez Blázquez11, Joan Antoni Gómez Hospital2, Rosana Hernández-Antolín12, Cinta Llibre8, Francisco Marín13, David Martí Sánchez14, Roberto Martín11, Manuel Martínez Sellés7, Gema Miñana15, María José Morales Gallardo14, Julio Núñez15, Armando Pérez de Prado9, Eduardo Pinar13, Marcelo Sanmartín12, Alessandro Sionis10, Adolfo Villa16, Jaume Marrugat17, Héctor Bueno11. 1. Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain. Electronic address: sanchis_juafor@gva.es. 2. Servicio de Cardiología, Hospital Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. 3. Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain. 4. Servicio de Cardiología, Hospital Universitario La Princesa, Madrid, Spain. 5. Servicio de Cardiología, Hospital Universitario Vall d'Hebron, CIBERCV, Barcelona, Spain. 6. Servicio de Cardiología, Hospital Moisès Broggi, Sant Joan Despí, Barcelona, Spain. 7. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Universidad Complutense, Universidad Europea, Madrid, Spain. 8. Servicio de Cardiología, Hospital Germans Trias i Pujol, CIBERCV, Badalona, Barcelona, Spain. 9. Servicio de Cardiología, Hospital de León, León, Spain. 10. Servicio de Cardiología, Hospital Sant Pau, CIBERCV, Barcelona, Spain. 11. Servicio de Cardiología, Hospital 12 de Octubre, Madrid, Spain. 12. Servicio de Cardiología, Hospital Ramon y Cajal, CIBERCV, Madrid, Spain. 13. Servicio de Cardiología, Hospital Virgen de la Arrixaca, CIBERCV, El Palmar, Murcia, Spain. 14. Servicio de Cardiología, Hospital Central de la Defensa, Madrid, Spain. 15. Servicio de Cardiología, Hospital Clínico Universitario de Valencia, INCLIVA, Universidad de Valencia, CIBERCV, Valencia, Spain. 16. Servicio de Cardiología, Hospital Universitario del Sureste, Arganda del Rey, Madrid, Spain. 17. Grupo de Epidemiología y Genética Cardiovascular, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), CIBERCV, Barcelona, Spain.
Abstract
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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.Identifier: NCT03208153.
RCT Entities:
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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.Identifier: NCT03208153.
Authors: Shouaib Qayyum; Jennifer Ann Rossington; Raj Chelliah; Joseph John; Benjamin J Davidson; Richard M Oliver; Dumbor Ngaage; Mahmoud Loubani; Miriam J Johnson; Angela Hoye Journal: Open Heart Date: 2020-09