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

Not Applicable

Terminated

• Conditions: Multi Vessel Coronary Artery Disease; Cardiovascular Diseases; Heart Diseases; Ischemic Heart Disease; Acute Coronary Syndrome; Arteriosclerosis
• Interventions: Procedure: Percutaneous coronary intervention (PCI)

• Registration Number: NCT04252703
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2020-05-13
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimalist	Percutaneous coronary intervention (PCI)	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.
More complete	Percutaneous coronary intervention (PCI)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.	12 months	Components of composite endpoint as defined below.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L quality of life assessment	12 months	Performed at study entry and at 12 months follow-up
Incidence of Cardiac death	12 months	defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia
Incidence of Urgent unplanned revascularization	12 months	(of the coronary arteries by either PCI or coronary bypass surgery)
Incidence of TIMI major and minor bleeding	12 months	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.
Seattle Angina Questionnaire score	12 months	Performed at study entry and at 12 months follow-up
Incidence of Myocardial infarction	12 months	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
Incidence of Stroke	12 months	Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)
Incidence of contrast-induced nephropathy after PCI	72 hours 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)

Trial Locations

Locations (1)

Department of Cardiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark