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

NCT04252703 | Terminated DMC

• 1 other identifier: H-18020388
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

ischemic heart disease; multivessel; octogenarians; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of Cardiac death

  12 months

• Incidence of Myocardial infarction

  12 months

• Incidence of Urgent unplanned revascularization

  12 months

• Incidence of TIMI major and minor bleeding

  12 months

• Incidence of Stroke

  12 months

Study Arms (2)

Minimalist

ACTIVE COMPARATOR

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)

More complete

EXPERIMENTAL

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)

Interventions

Percutaneous coronary intervention (PCI) PROCEDURE

Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

Minimalist; More complete

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Vascular Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thomas Engstrøm, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Francis Joshi, MD,PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Interventional Cardiologist

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: May 13, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)