A Trial in Stable Intermediate Coronary Lesions and Grey-zone FFR Values (GzFFR)

Golden Jubilee National Hospital

Status: Completed

Conditions: Grey-zone Fractional Flow Reserve; Stable Angina; Coronary Physiology; Intermediate Coronary Lesions

Treatments: Procedure: PCI; Drug: Optimal Medical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02425969

GzFFR Protocol Version 2.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients >18 years
2. 30-80% Diameter Stenosis on QCA
3. Stable angina
4. Non ST-elevation myocardial infarction (NSTEMI) with stable symptoms
5. Able to provide informed consent

Exclusion criteria

1. STEMI within 5 days
2. Tortuous vessels which would render pressure wire studies difficult or impossible
3. Heavily calcified vessels which would render pressure wire studies difficult or impossible
4. Unstable symptoms requiring definitive interventional management
5. Severe claustrophobia
6. Age >90 years
7. Life expectancy <1 year
8. Estimated Glomerular Filtration Rate <30 mls/min/1.73m2
9. Inability to undergo MRI scanning due to metallic implant or incompatible permanent pacemaker
10. Severe asthma or inability to safely receive an adenosine infusion
11. Left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Optimal Medical Therapy

Experimental group

Description:

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

Treatment:

Drug: Optimal Medical Therapy

PCI with Optimal Medical Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Optimal Medical Therapy

Procedure: PCI