Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia (EVAOLD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03289728|
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Other: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE) Procedure: Cornorary angioplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1756 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Strategy guided by ischemia imaging
Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines.
- Low or intermediate risk patients will receive optimal medical treatment.
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).
Active Comparator: Systematic coronary angioplasty
Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
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.
- Rate of MACCE [ Time Frame: 12 months ]Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
- Rate of MACCEs and each component of the MACCEs criteria during index hospitalization [ Time Frame: 1, 6 and 12 months ]MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
- 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 [ Time Frame: 12 months ]
- 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 [ Time Frame: 12 months ]
- Quality of life using standardized scale : EQ5D-5L [ Time Frame: 1, 6 and 12 months ]
- Frailty assessment [ Time Frame: 1 week ]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
- Dependency (ADL) [ Time Frame: 1, 6, 12 months ]
- Autonomy (IADL) [ Time Frame: 1, 6, 12 months ]
- Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score [ Time Frame: 1. 6, 12 months ]
- Rate of MACCE according to sub-group analysis [ Time Frame: 1. 6, 12 months ]Sub group : age, gender, diabetes, renal failure and frailty
- Create prognostic model with multivariate survival analysis : [ Time Frame: 1. 6, 12 months ]Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289728
|Contact: Gilles Barone-Rochette, MD, PhDfirstname.lastname@example.org|
|Contact: Clémence CHARLONemail@example.com|
|Principal Investigator: BENJAMIN FAURIE, MD|
|University Hospital Grenoble||Recruiting|
|Contact: GILLES BARONE ROCHETTE, MD PHD|
|Contact: CLEMENCE CHARLON CCHARLON@CHU-GRENOBLE.FR|
|Principal Investigator: GILLES BARONE ROCHETTE, MD PHD|
|Principal Investigator:||Gilles Barone-Rochette, MD, PhD||University Hospital, Grenoble|