Original articleInvasive 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
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.
References (29)
- et al.
Prognostic Value of Geriatric Conditions Beyond Age After Acute Coronary Syndrome
Mayo Clin Proc.
(2017) - et al.
Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction
Eur J Intern Med.
(2016) - et al.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
J Chronic Dis.
(1987) - et al.
Cognitive function and health-related quality of life four years after cardiac arrest
Resuscitation.
(2015) - et al.
Influence of comorbid conditions on one-year outcomes in non-ST-segment elevation acute coronary syndrome
Mayo Clin Proc.
(2011) - et al.
Frailty and outcome in elderly patients with acute coronary syndrome
Can J Cardiol.
(2013) - et al.
Selection of the Best of 2016 on the Management of Acute Coronary Syndromes in Elderly Patients
Rev Esp Cardiol.
(2017) - et al.
Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial
JACC Cardiovasc Interv.
(2012) - et al.
Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial
Lancet.
(2016) - et al.
Percutaneous Coronary Intervention and Recurrent Hospitalizations in Elderly Patients with Non ST-segment Acute Coronary Syndrome: The Role of Frailty
Int J Cardiol.
(2017)