Older patients with co-morbidity are increasingly represented in interventional cardiology practice. They have been historically excluded from studies regarding the optimal management of NSTEACS. Though there are associated risks with invasive treatment, such patients likely derive the greatest absolute benefit from PCI. Small, though highly selective, studies suggest a routine invasive strategy may reduce the risk of recurrent myocardial infarction. The study aims to include, as far as possible, an 'all-comers' population of patients aged 80 and above to define the optimum amount of revascularization required to achieve good outcomes and satisfactory symptom relief for this challenging cohort of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.
Department of Cardiology, Rigshospitalet
Copenhagen, Denmark
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
Components of composite endpoint as defined below.
Time frame: 12 months
Incidence of Cardiac death
defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia
Time frame: 12 months
Incidence of Myocardial infarction
Periprocedural myocardial infarction is defined as a CK-MB x 5 upper limit of normal (ULN) with ECG or angiographic evidence of ischaemia, or CK-MB x 10 ULN
Time frame: 12 months
Incidence of Urgent unplanned revascularization
(of the coronary arteries by either PCI or coronary bypass surgery)
Time frame: 12 months
Incidence of TIMI major and minor bleeding
defined as any symptomatic intracranial haemorrhage or clinically overt signs of haemorrhage (including imaging) associated with a drop in haemoglobin of ≥ 5g/dL. Minor bleeding is defined as any clinically overt sign of haemorrhage (including imaging) that is associated with a fall in haemoglobin concentration of 3 to ≤5 g/dL.
Time frame: 12 months
Incidence of Stroke
Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)
Time frame: 12 months
Incidence of contrast-induced nephropathy after PCI
Defined as a 25% relative increase, or a 44μmol/L absolute increase in serum creatinine within 72 hours of contrast exposure in the absence of an alternative explanation)
Time frame: 72 hours after PCI
Seattle Angina Questionnaire score
Performed at study entry and at 12 months follow-up
Time frame: 12 months
EQ-5D-5L quality of life assessment
Performed at study entry and at 12 months follow-up
Time frame: 12 months
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