Clinical trial NCT03289728: Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia
Official title: Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: elderly patients
myocardial infarction
myocardial revascularization strategy
ischemia imaging
coronary artery disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 1756
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20 years due to the aging population. Myocardial infarction without ST segment elevation (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients remains a challenging question.

Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.

Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.

For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.

The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.


Eligibility criteria: Inclusion Criteria:

* Patients aged 80 years or older
* Hospitalized for NSTEMI with or without ST-segment depression on electrocardiogram (ECG), and with raised blood concentration of troponin T or I. Raised troponin was defined as a value exceeding the 99th percentile of a normal population at the local laboratory at each participating site. A local cardiologist assessed patient eligibility and clinical condition compatible with a doubt for systematic coronary angiography due to a frailty.
* Written informed consent by the patient or the next of kin in case of incapacity.

Non-inclusion criteria:

* Recurrent or ongoing chest pain refractory to medical treatment
* Haemodynamic instability or cardiogenic shock
* Life-threatening arrhythmias or cardiac arrest
* Contra-indication to CA: Renal failure (creatinine clearance \<15 mL/min by Modification of the Diet in Renal Disease (MDRD)), continuing bleeding problems
* Mechanical complications of MI
* Severe aortic stenosis
* Medical history of severe dementia (documented for more than 3 months)
* Patient under administrative or judicial control
* Patient who are protected under the act
* No health care insurance

Primary outcomes:
measure: Rate of MACCE
timeFrame: 12 months
Secondary outcomes:
measure: Rate of MACCEs and each component of the MACCEs criteria during index hospitalization
timeFrame: 1, 6 and 12 months
measure: Incremental cost-effectiveness ratio (ICER) expressed as the extra cost for a QALY (quality adjusted life year) gained by the strategy guided by ischemia imaging compared to the systemic coronary angioplasty strategy
timeFrame: 12 months
measure: The annual financial impact of implementing the strategy guided by ischemia imaging will be calculated from the French Health Insurance System perspective over three years
timeFrame: 12 months
measure: Quality of life using standardized scale : EQ5D-5L
timeFrame: 1, 6 and 12 months
measure: Frailty assessment
timeFrame: 1 week
measure: Dependency (ADL)
timeFrame: 1, 6, 12 months
measure: Autonomy (IADL)
timeFrame: 1, 6, 12 months
measure: Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3
timeFrame: 1. 6, 12 months
measure: Rate of MACCE according to sub-group analysis
timeFrame: 1. 6, 12 months
measure: Create prognostic model with multivariate survival analysis :
timeFrame: 1. 6, 12 months
measure: Rate of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, resuscitated cardiac arrest and ischemia-driven coronary revascularization procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique Mutualiste
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles Barone-Rochette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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