Original article
Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study DesignEstrategia invasiva frente a conservadora en pacientes frágiles con IAMSEST. Diseño del ensayo clínico MOSCA-FRAIL

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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.

Resumen

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 pacientes habitualmente quedan excluidos de los ensayos clínicos, por lo que la evidencia es escasa. La 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 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

La 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. Registro de ensayos cl-nicos: URL: http://www.clinicaltrials.gov.Identificador único: NCT03208153.

Section snippets

INTRODUCTION

Frailty is defined as a physiologic state of decreased resistance to stressors that results from decreased physiologic reserves of multiple systems and causes vulnerability to adverse outcomes.1 Acute coronary syndromes imply a major stressor for frail patients. Indeed, frailty predicts short- and long-term mortality after acute coronary syndrome.2, 3, 4, 5, 6, 7 Furthermore, among geriatric conditions (namely physical disability, instrumental disability, cognitive impairment, and

Study Design

This is an investigator-mediated, prospective, multicenter, randomized clinical trial comparing an invasive vs a noninvasive strategy in patients with NSTEMI, aged ≥ 70 years with frailty. Patients will be eligible for inclusion if they fulfill all 3 of the following inclusion criteria: a) NSTEMI, defined by acute chest pain, absence of persistent ST-segment elevation in the presence of interpretable repolarization and troponin elevation (according to the local laboratory troponin assay); b)

DISCUSSION

The prevalence of frailty in older patients admitted for acute coronary syndrome ranges between 27% and 34%.4, 19 Its presence is associated with mortality risk, both during admission and after discharge.2, 3, 4, 5, 6, 7 This might be partly due to the underuse of guideline-recommended therapies. Clinical guidelines recommend a routine invasive strategy in NSTEMI.20 Nevertheless, invasive management is underused in frail and comorbid patients.2, 21, 22, 23 This policy might derive from the

CONCLUSIONS

The optimal management strategy for frail patients with NSTEMI is unknown. No trial has been designed for this particular population so far. 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.

FUNDING

This work was supported by grants from Spain's Ministry of Economy and Competitiveness through the Carlos III Health Institute: FIS 17/01736, FIS 17/00899 and FIS 15/00837, FEDER; CIBER-CV 16/11/00420, Madrid, Spain. It is also supported by the SCReN-Spanish Clinical Research Network (PT13/0002/0031; PT17/0017/0003) from the National R + D + I Plan of the Institute of Health Carlos III (Ministry of Economy and Competitiveness: Cofinanced by European Regional Development Fund “A way to make

CONFLICTS OF INTEREST

E. Abu-Assi is Associate Editor of Revista Española de Cardiología.

H. Bueno reports grants and personal fees from AstraZeneca, personal fees from Daiichi Sankyo, personal fees from Eli Lilly, personal fees from Bayer, personal fees from Sanofi, during the conduct of the study; personal fees from Novartis, personal fees from BMS-Pfizer, from Servier, outside the submitted work.

J. Núñez reports personal fees from Novartis, personal fees from Vifor, personal fees from Abbott, personal fees from

Acknowledgments

The authors thank Marta Peiró, M. Dolores Iglesias and Mireia Hernández, for monitoring the study.

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