Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes

Study Overview
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Brief Summary
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For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.

Official Title
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A Prospective Randomised Controlled Trial

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Drug: Conservative Arm
* Procedure: Invasive Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AGE>80 Non-STEMI - characteristic chest pain accompanied by Typical ischaemic ECG changes A troponin rise Suitable for conservative or invasive strategy Exclusion Criteria: Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity Acute STEMI Cardiogenic shock Platelet count =50 x 109/mm3 Patient life expectancy < 1 year Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant Recent major GI haemorrhage (within 3 months) Any previous cerebral bleeding episode Participation in another investigational drug or device study Patient unable to give consent Clinical decision precluding the use of stents

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conservative Arm- Medical therapy<br>Medical therapy | Drug: Conservative Arm<br>* crossover to angiogram only if predefined criteria met<br>* Other names: ACE inhibitor (Ramipril or equivalent);|
| Other: Invasive Arm-angiogram with PCI or CABG<br>same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate | Procedure: Invasive Arm<br>* angiogram with PCI or CABG revascularisation if appropriate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes. Cardiovascular Death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke or death due to other cardiovascular causes Non-Cardiovascular Death is defined as any death not covered by cardiac death or vascular death. Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a non-cardiovascular cause. N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category. | 1 year | 
| non-fatal myocardial infarction | The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned revascularisation | Shall be deemed to have occurred at follow-up if any coronary vessel requires or undergoes attempted repeat revascularisation with either balloon angioplasty, stenting, or coronary artery bypass grafting. | 1 years | 
| Permanent Stroke | A stroke is a loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death | 1 year | 
| Major bleeding | BARC (Bleeding Academic Research Consortium) definition | 1 year | 
| Deterioration of renal function during hospital admission | Worsening renal function is an absolute increase in serum creatinine of ≥ 0.3mg/dl (26.5 umol/l) at any time during hospitalization compared to the valve obtained at admission | During index admission | 
| Angina symptoms (3 months; 1yr) | CCS (Canadian Cardiovascular Society Classification of angina) grading of angina | 3 months and 1 year | 
| Stent thrombosis | ARC definition of stent Thrombosis | 1 year | 
| All cause mortality | Cardiac and non cardiac mortality | 2,3 and 4 year | 
| Hospital readmission for ACS/STEMI | ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction) | At 3, 6 and 12 months and at 2,3 and 4 years | 
| In-hospital major complications | In hospital major complications defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. | At 3, 6 and 12 months and at 2,3 and 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revascularisation, octogenarian,acute coronary syndromes