A Randomised Controlled Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values With Evaluation of the Diagnostic Utility of Invasive Coronary Physiological Indices and Quantitative Perfusion MRI. The GzFFR Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Angina status as per Seattle Angina Questionnaire
Study Overview
Brief Summary
In this randomised controlled trial of patients with stable angina and documented intermediate coronary disease with indeterminate or "grey-zone" Fractional Flow Reserve (FFR) we will randomise patients to either optimal medical therapy alone versus optimal medical therapy with PCI and they will be followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.
Detailed Description
Pressure derived fractional flow reserve (FFR) is recognised as being the gold standard method of assessing the physiological significance of angiographically intermediate lesions. A grey-zone exists between the originally validated cut-off for ischemia of <0.75 and the conventionally adopted cut- off of ≤0.80. Pilot data from our centre has suggested that only 1 in 3 coronary arteries with grey-zone FFR values demonstrate myocardial perfusion defects on stress cardiac MRI and others have suggested that the clinical outcomes in patients with grey-zone FFR are favorable with medical therapy alone. As such, stenting all lesions with grey-zone FFR (as currently recommended) may represent over-treatment and could attenuate the overall benefit of an FFR strategy. In addition to this there are flow derived resistance indices of stenosis severity that have superior diagnostic accuracy and may be helpful in correctly classifying patients with grey-zone FFR. In this study we will a comprehensive analysis of lesions with grey-zone FFR values (0.75-0.82 inclusive) using invasive hyperemic pressure, flow and resistance derived indices of severity with quantitative and qualitative 3T perfusion MRI to enable identification of the best invasive predictors of true perfusion defects on 3T cardiac MRI. Patients will be randomised to optimal medical therapy alone versus optimal medical therapy with PCI and followed up for the primary endpoint of anginal control as measured by the Seattle Angina Questionnaire at 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients >18 years
- •30-80% Diameter Stenosis on QCA
- •Stable angina
- •Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
- •Able to provide informed consent
Exclusion Criteria
- •STEMI within 5 days
- •Tortuous vessels which would render pressure wire studies difficult or impossible
- •Heavily calcified vessels which would render pressure wire studies difficult or impossible
- •Unstable symptoms requiring definitive interventional management
- •Severe claustrophobia
- •Age >90 years
- •Life expectancy <1 year
- •Estimated Glomerular Filtration Rate <30 mls/min/1.73m2
- •Inability to undergo MRI scanning due to metallic implant or incompatible permanent pacemaker
- •Severe asthma or inability to safely receive an adenosine infusion
- •Left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.
Arms & Interventions
Optimal Medical Therapy
Patients will receive secondary prevention and optimal medical therapy to control their anginal symptoms according to international guidelines without PCI of their grey-zone FFR lesion
Intervention: Optimal Medical Therapy (Drug)
PCI with Optimal Medical Therapy
Patients will undergo PCI of their grey-zone FFR lesion as well as appropriate secondary prevention. Anti-anginal therapy will be administered as per clinical requirements according to international guidelines.
Intervention: PCI (Procedure)
PCI with Optimal Medical Therapy
Patients will undergo PCI of their grey-zone FFR lesion as well as appropriate secondary prevention. Anti-anginal therapy will be administered as per clinical requirements according to international guidelines.
Intervention: Optimal Medical Therapy (Drug)
Outcomes
Primary Outcomes
Angina status as per Seattle Angina Questionnaire
Time Frame: 3 months
Anginal severity as measured by the Seattle Angina Score at 3 months compared with baseline in patients randomized to PCI versus medical therapy.
Secondary Outcomes
- Total number of anti-anginal medications(3 and 12 months)
- MACE(3 and 12 months)
- Myocardial infarction(3 and 12 months)
- Urgent Revascularisation(3 and 12 months)