Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study
Key result
ICON1 evaluates 1-year ischemic and bleeding outcomes in patients aged 75 and older with NSTEACS.
- n=300
Population
Older patients with non-ST-elevation acute coronary syndrome planned for coronary angiogram or percutaneous…
Design
Cohort, Operator blinded to VH-IVUS and OCT data during the procedure
Follow-up
30 days and 1 year
Authors
Discussion
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Implication
The ICON1 study is a prospective observational cohort designed to identify predictors of adverse outcomes and develop a risk prediction tool for patients aged ≥75 years undergoing invasive management for NSTEACS.
Study Design
Type
Observational (n=300)
Multicenter
Yes
Structured PICO
P
Population
300 older adults (aged ≥75 years) with non-ST-elevation acute coronary syndrome undergoing invasive management, followed for 1 year to determine predictors of adverse outcomes.
E
Exposure
Contemporary invasive management (coronary angiography with a view to revascularisation via PCI or CABG) and pharmacological treatment.
O
Outcome
Composite of death, myocardial infarction, stroke, repeat unplanned revascularisation, and BARC-defined bleeding (type 2 or greater) at 1 year.composite
The ICON1 study is a prospective observational cohort designed to identify predictors of adverse outcomes and develop a risk prediction tool for patients aged ≥75 years undergoing invasive management for NSTEACS.
Limitations
- Non-randomised character of the study, which cannot derive definitive insights regarding causality of factors associated with clinical outcomes
- Intracoronary imaging will be performed in only a subset of patients recruited due to anatomical contraindications and patient wishes
- Non-randomised character of the study, which is not able to derive definitive insights regarding causality
- Intracoronary imaging will be performed in only a subset of patients recruited owing to anatomical contraindications and patient wishes
Cite This Study
Kunadian et al. (2016) conducted an observational in Non-ST-elevation acute coronary syndrome (NSTEACS) (n=300). Frailty and comorbid status was evaluated on Composite of death, MI, stroke, repeat, unplanned revascularisation and BARC-defined bleeding (type 2 or greater) at 1 year. The ICON1 study is an ongoing prospective observational study designed to identify predictors of adverse cardiovascular outcomes at 1 year in patients aged 75 years and older with NSTEACS.