Estrategia invasiva frente a conservadora en pacientes frágiles con IAMSEST. Diseño del ensayo clínico MOSCA-FRAIL / Invasive versus conservative strategy in frail patients with NSTEMI: the MOSCA-FRAIL clinical trial study design

Introducción y objetivos: Aunque las guías de práctica clínica recomiendan una estrategia invasiva para el infarto agudo de miocardio sin elevación del segmento ST (IAMSEST), en la práctica clínica esta estrategia se infrautiliza en ancianos frágiles. Además estos enfermos habitualmente quedan excluidos de los ensayos clínicos, por lo que la evidencia es escasa. Nuestra hipótesis es que una estrategia invasiva para el anciano con fragilidad y IAMSEST mejorará el pronóstico. Métodos: Se trata de un estudio prospectivo, multicéntrico y aleatorizado que compara una estrategia invasiva frente a una conservadora en ancianos frágiles con IAMSEST. Los criterios de inclusión son: IAMSEST, edad ≥ 70 años y fragilidad definida por al menos 4 criterios de la escala Clinical Frailty Scale. Se aleatorizará a los participantes a una estrategia invasiva (coronariografía y revascularización si se considera anatómicamente indicada) o conservadora (tratamiento médico y coronariografía solo en caso de inestabilidad clínica persistente). El objetivo principal será el número de días vivo fuera del hospital durante el primer año. El objetivo coprincipal será el tiempo hasta la presentación de muerte cardiovascular, reinfarto agudo de miocardio o revascularización tras el alta. El tamaño de la muestra estimado es de 178 pacientes (89 por grupo), asumiendo un incremento del 20% en la proporción de días vivo fuera del hospital con la estrategia invasiva. Resultados: Los resultados del estudio aportarán información novedosa para el tratamiento del anciano frágil con IAMSEST. Conclusiones: Nuestra hipótesis es que una estrategia invasiva mejorará el pronóstico de los pacientes ancianos frágiles con IAMSEST. Si esta hipótesis se confirmara, la situación de fragilidad no debería disuadir al cardiólogo de indicar un tratamiento invasivo. Ensayo registrado en ClinicalTrials.gov (Identificador: NCT03208153)

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

Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design.

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.