To assess whether the iFR is non-inferior to FFR when used to guide treamtent of coronary stenoses with PCI
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major adverse cardiac events (MACE) rate in the oFR and FFR groups at 30 days,
1, 2, and 5 years.
Secondary outcome
1. Death (all cause) at 30 days, 1, 2, and 5 years.
2. Death (cardiovascular) at 30 days, 1, 2, and 5 years.
3. Myocardial infarction at 30 days, 1, 2, and 5 years.
4. Repeat revascularization by PCI or coronary artery bypass graft surgery
(CABG) at 30 days, 1, 2, and 5 years.
5. Costs associated with iFR or FFR guidance.
6. Quality of Lide (QOL) of patients included in the iFR or FFR guidance groups
7. Cost savings of removing secondary inverigations, by assessing.treating
non-culprit acute coronary syndrome (ACS) at the time of index presentation.
Background summary
Decisions to perform or defer percutaneous coronary intervention (PCI) on the
basis of physiological stenosis severity using fractional flow reserve (FFR)
are safe and reduce stent implantation rates. Despite the evidence, this
modality of ischemia driven revascularisation is applied only in s small
proprtion of patients undergoimg PCI (6-10%). The reaons dor this are
multifactorial, including partial or inadequate reimbursement, availability of
suitable measurement equipment, or accessibility to pharmocological agents.
Additionally, FFR adds on average 10 minutes to the procedure, which further
discourages widespread adoption. This is particularly relevant in multi-vessel
disease: multi-vessel assessment is rarely performed and when it is, takes
considerably more time.
Recently a new technique for measuring physiological lesion severity,
instantaneous wave-free ratio (iFR) was introduced. iFR, is very similar to the
conventional measurement technique, but differs crucially as it does not
require the administration of pharmacological vasodilators (such as adenosine).
To date, iFR has been assessed extensively over 18 months, being used in over
3000 lesions, principally in comparisons with FFR, wchih is commonly held as
the reference standard for classifying stenoses according to haemodynamic
severity.
The results of these studies suggest that iFR is a valid diagnostic tool in the
catheterisation laboratory. yet, widespread applicability of iFR in clinical
practice will require studies investigating the equivalence of iFR to FFR in
terms of patient outcomes when used as a clinical decision making tool in
patients in whom PCI is considered as a potential treament.
The FLAIR study is designed to thoroughly assess whether iFR-informed treatment
decisions are non-inferior to FFR-informed decisions for the treatment or
deferral of PCI.
Study objective
To assess whether the iFR is non-inferior to FFR when used to guide treamtent
of coronary stenoses with PCI
Study design
Prospective multi-center randomised study.
Intervention
iFR- versus FFR-guided decision making on revascularisation or deferral of
coronary stenoses
Study burden and risks
The risks associated with participation in the study are equivalent of those
associated with standard FFR-guidance of treatment. De patien burden consists
of telephone contact at 6 months, and a clinical visit at 30 days, 1,2,and 5
years after the procedure.
North Wharf Road 59-61
London W2 1LA
GB
North Wharf Road 59-61
London W2 1LA
GB
Listed location countries
Age
Inclusion criteria
1. Age>18 years of age
2. Willing to participate and able to understand, read, and sign the informed consent document before the planned procedure.
3. Eligible for coronary angiography and/or percutaneous coronary intervention
4. Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-70% diameter stenosis).
5. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
Exclusion criteria
1. Previous CABG with patents grafts to the interrogated vessel
2. Left main stenosis
3. Tandem stenoses separated by more than 10mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis).
4. total coronary occlusions.
5. Restenotic lesions.
6. Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg, balloon pump).
7. Significant contraindication to adenosine administration (e.g. heart block, severe asthma).
8. Contraindications to PCI or drug-eluting stent (DES) implantation.
9. Heavily calcified or tortuous vessels
10. Significant hepatic or lung disease (chronic pulmonary obstructive disease), and/or malignant disease with unfavourable prognosis that may influence survival within the next 5 years.
11. Pregnancy
12. STEMI wihin 48 hours of procedure.
13. Severe valvular disease.
14. ACS patients in whom more than one target vessel is present.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46999.018.13 |