TerminatedNot Applicable

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

Stopped: Very slow recruitment - only 3 patients randomised and then COVID-19

Denmark3 participantsStarted 2020-05-13

Plain-language 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.

Who can participate

Age range80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tr…

What they're measuring

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

Trial details

NCT IDNCT04252703

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-01