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Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):154-159. doi: 10.1016/j.rec.2018.02.007. Epub 2018 Mar 7.

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

[Article in English, Spanish]

Author information

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.

KEYWORDS:

Acute myocardial infarction; Anciano; Elderly; Fragilidad; Frailty; Infarto agudo de miocardio

PMID:
29525724
DOI:
10.1016/j.rec.2018.02.007

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