'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multi Vessel Coronary Artery Disease
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Francis Joshi
Principal Investigator, Interventional Cardiologist
Rigshospitalet, Denmark
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
Time Frame: 12 months
Components of composite endpoint as defined below.
Secondary Outcomes
- EQ-5D-5L quality of life assessment(12 months)
- Incidence of Urgent unplanned revascularization(12 months)
- Incidence of Cardiac death(12 months)
- Incidence of Myocardial infarction(12 months)
- Incidence of TIMI major and minor bleeding(12 months)
- Seattle Angina Questionnaire score(12 months)
- Incidence of Stroke(12 months)
- Incidence of contrast-induced nephropathy after PCI(72 hours after PCI)