Clinical trial NCT04252703: 'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians
Official title: 'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multi Vessel Coronary Artery Disease
Ischemic Heart Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Keywords: ischemic heart disease
multivessel
octogenarians
acute coronary syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Cardiac death
timeFrame: 12 months
measure: Incidence of Myocardial infarction
timeFrame: 12 months
measure: Incidence of Urgent unplanned revascularization
timeFrame: 12 months
measure: Incidence of TIMI major and minor bleeding
timeFrame: 12 months
measure: Incidence of Stroke
timeFrame: 12 months
measure: Incidence of contrast-induced nephropathy after PCI
timeFrame: 72 hours after PCI
measure: Seattle Angina Questionnaire score
timeFrame: 12 months
measure: EQ-5D-5L quality of life assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas Engstrøm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Francis Joshi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: