Acute Coronary Syndromes
Conditions
Keywords
Revascularisation, octogenarian,acute coronary syndromes
Brief summary
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.
Interventions
DRUGConservative Arm
crossover to angiogram only if predefined criteria met
PROCEDUREInvasive Arm
angiogram with PCI or CABG revascularisation if appropriate
Sponsors
Medtronic Vascular
Brighton and Sussex University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 1 year | 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. |
| non-fatal myocardial infarction | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Permanent Stroke | 1 year | 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 |
| Major bleeding | 1 year | BARC (Bleeding Academic Research Consortium) definition |
| Deterioration of renal function during hospital admission | During index 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 |
| Hospital readmission for ACS/STEMI | At 3, 6 and 12 months and at 2,3 and 4 years | ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction) |
| Stent thrombosis | 1 year | ARC definition of stent Thrombosis |
| All cause mortality | 2,3 and 4 year | Cardiac and non cardiac mortality |
| In-hospital major complications | At 3, 6 and 12 months and at 2,3 and 4 | 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. |
| Angina symptoms (3 months; 1yr) | 3 months and 1 year | CCS (Canadian Cardiovascular Society Classification of angina) grading of angina |
| Unplanned revascularisation | 1 years | 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. |
Countries
United Kingdom
Outcome results
None listed