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

Not Applicable

Completed

• Conditions: Coronary Physiology; Grey-zone Fractional Flow Reserve; Intermediate Coronary Lesions; Stable Angina
• Interventions: Drug: Optimal Medical Therapy; Procedure: PCI

• Registration Number: NCT02425969
• Lead Sponsor: Golden Jubilee National Hospital

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 Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-30
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2016-10-01
• Study Completion: 2016-10-01
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal Medical Therapy	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
PCI with Optimal Medical Therapy	PCI	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.
PCI with Optimal Medical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Angina status as per Seattle Angina Questionnaire	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 Outcome Measures

Name	Time	Method
Total number of anti-anginal medications	3 and 12 months	Total number of anti-anginal medications in patients randomized to PCI versus medical therapy.
Urgent Revascularisation	3 and 12 months	Urgent Revascularisation of the grey-zone FFR lesion in patients randomized to PCI versus medical therapy.
MACE	3 and 12 months	MACE (Death, myocardial infarction, urgent revascularisation and stroke) in patients randomized to PCI versus medical therapy.
Myocardial infarction	3 and 12 months	Myocardial infarction in patients randomized to PCI versus medical therapy.

Trial Locations

Locations (1)

Golden Jubilee National Hospital; 🇬🇧 Glasgow, Dunbartonshire, United Kingdom