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

NCT ID: NCT04252703

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2022-01-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

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.

Group Type: EXPERIMENTAL

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

Interventions

Percutaneous coronary intervention (PCI)

Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Francis Joshi

Principal Investigator, Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Engstrøm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Francis Joshi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Department of Cardiology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-18020388

Identifier Type: -

Identifier Source: org_study_id