'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians

'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial

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 Overview

• Status: Terminated
• Conditions: Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Acute Coronary Syndrome; Ischemic Heart Disease; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention (PCI)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Cardiology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Minimalist; The 'Minimalist' strategy is PCI treatment of the culprit lesion only. Other coronary stenoses are to be managed medically. It is recognized that there may be multiple culprit lesions in such patients, though there are no data on how frequently this might be expected. Operators may elect to treat multiple putative culprit lesions in this case.	Procedure: Percutaneous coronary intervention (PCI); Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.
Experimental: More complete; The 'More complete' strategy is PCI of the culprit lesion and fractional flow reserve (FFR)- or instantaneous wave-free ratio (iFR)-guided treatment of other angiographically significant (> 50% diameter) stenoses amenable to coronary stenting in vessels with reference diameters ≥2.5mm. Physiological assessment is strongly encouraged but not mandatory for lesions of ≥90% angiographic stenosis. PCI of chronic total occlusions will not be attempted as part of the study.	Procedure: Percutaneous coronary intervention (PCI); Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Cardiac death	defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia	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	12 months
Incidence of Urgent unplanned revascularization	(of the coronary arteries by either PCI or coronary bypass surgery)	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.	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)	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)	72 hours after PCI
Seattle Angina Questionnaire score	Performed at study entry and at 12 months follow-up	12 months
EQ-5D-5L quality of life assessment	Performed at study entry and at 12 months follow-up	12 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Thomas Engstrøm, MD, PhD, Rigshospitalet, Denmark; Principal Investigator: Francis Joshi, MD,PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ischemic heart disease; acute coronary syndrome; multivessel; octogenarians
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Arterial Occlusive Diseases; Disease; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Syndrome; Arteriosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: H-18020388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No