Acute Coronary Syndrome, Arteriosclerosis, Cardiovascular Diseases, Heart Diseases, Ischemic Heart Disease, Multi Vessel Coronary Artery Disease
Conditions
Keywords
ischemic heart disease, multivessel, octogenarians, acute coronary syndrome
Brief summary
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.
Interventions
PROCEDUREPercutaneous coronary intervention (PCI)
Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥80 years * Non-ST-elevation acute coronary syndromes, defined as per guidelines: * Ischaemic chest pain or equivalent AND either * Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR * Biomarker positive for myocardial necrosis * Multi-vessel coronary artery disease, defined as the presence of an angiographic \>90% diameter or FFR-(\<0.81) or iFR-(\<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.
Exclusion criteria
* Inability to give written informed consent * Resuscitation from cardiac arrest * Life expectancy \<12 months * Cardiogenic shock * Ventricular arrhythmias refractory to treatment at the time of randomization * Coronary artery disease not amenable to PCI * Heart Team decision for coronary bypass surgery * Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation * Estimated glomerular filtration rate (eGFR) \<20mL/min/m2 (by Cockcroft-Gault formula) * Documented anaphylaxis induced by iodinated contrast media * Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants * Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following: * Active internal bleeding * Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation * Platelet count \<90,000/μL at screening * Previous intracranial haemorrhage * Clinically significant gastrointestinal bleeding within 12 months before randomization * Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal * Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days * Any active non-cutaneous malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months. | 12 months | Components of composite endpoint as defined below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Myocardial infarction | 12 months | 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 |
| Incidence of Urgent unplanned revascularization | 12 months | (of the coronary arteries by either PCI or coronary bypass surgery) |
| Incidence of TIMI major and minor bleeding | 12 months | 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. |
| Incidence of Cardiac death | 12 months | defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia |
| Incidence of contrast-induced nephropathy after PCI | 72 hours 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) |
| Seattle Angina Questionnaire score | 12 months | Performed at study entry and at 12 months follow-up |
| EQ-5D-5L quality of life assessment | 12 months | Performed at study entry and at 12 months follow-up |
| Incidence of Stroke | 12 months | Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) |
Countries
Denmark
Outcome results
None listed