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

Rigshospitalet

Status: Terminated

Conditions: Ischemic Heart Disease; Multi Vessel Coronary Artery Disease; Acute Coronary Syndrome; Cardiovascular Diseases; Arteriosclerosis; Heart Diseases

Treatments: Procedure: Percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04252703

H-18020388

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Minimalist

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous coronary intervention (PCI)

More complete

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous coronary intervention (PCI)