Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 588
- 试验地点
- 4
- 主要终点
- Rate of MACCE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Systematic coronary angioplasty
Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
干预措施: Cornorary angioplasty (Procedure)
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.
干预措施: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE) (Other)
结局指标
主要结局
Rate of MACCE
时间窗: 12 months
Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
次要结局
- Dependency (ADL)(1, 6, 12 months)
- 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)
- Quality of life using standardized scale : EQ5D-5L(1, 6 and 12 months)
- Autonomy (IADL)(1, 6, 12 months)
- Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3(1. 6, 12 months)
- Create prognostic model with multivariate survival analysis :(1. 6, 12 months)
- Rate of MACCEs and each component of the MACCEs criteria during index hospitalization(1, 6 and 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(12 months)
- Frailty assessment(1 week)
- Rate of MACCE according to sub-group analysis(1. 6, 12 months)
- 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)