Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia

Myocardial Infarction Clinical Trial

— EVAOLD  

Official title:

Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03289728
• Other study ID #: 38RC17.012
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: Gilles Barone-Rochette, MD, PhD
• Phone: +33476765172
• Email: gbarone[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1756
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction

Intervention

Other:
• Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)
Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol. Patients with = moderate ischemia observed by SPECT (= 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (= 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with < moderate ischemia will receive medical treatment only (MT).

Procedure:
• Cornorary angioplasty
Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.

Locations

Country	Name	City	State
France	Clinique Mutualiste	Grenoble
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MACCE	Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)	12 months
Secondary	Rate of MACCEs and each component of the MACCEs criteria during index hospitalization	MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)	1, 6 and 12 months
Secondary	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		12 months
Secondary	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		12 months
Secondary	Quality of life using standardized scale : EQ5D-5L		1, 6 and 12 months
Secondary	Frailty assessment	Multiple assessment are necessary to evaluate patient frailty: ADL, IADL, CAM, MNA, Charlson score, SEGA, MMSE, Time up and go test, mini GDS, history of fall	1 week
Secondary	Dependency (ADL)		1, 6, 12 months
Secondary	Autonomy (IADL)		1, 6, 12 months
Secondary	Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score = 3		1. 6, 12 months
Secondary	Rate of MACCE according to sub-group analysis	Sub group : age, gender, diabetes, renal failure and frailty	1. 6, 12 months
Secondary	Create prognostic model with multivariate survival analysis :	Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)	1. 6, 12 months
Secondary	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		12 months