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iFR Outcome Data
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More than 4500 patients, 2 prospective randomized controlled trials, published in the prestigious The New England Journal of Medicine. Learn more DEFINE FLAIR, iFR Swedeheart.
* p-values are for non-inferiority of an iFR-guided strategy versus an FFR-guided strategy with respect to 1-year MACE rates; pre-specified
non-inferiority margins were 3.4% and 3.2% in DEFINE FLAIR and iFR Swedeheart, respectively
0.89 dichotomous cut-point, backed by data 1,2,4
Both DEFINE FLAIR and iFR Swedeheart used a dichotomous 0.89 cut-point in their protocols to assess patient outcomes. By using a 0.89 cut-point, as validated in one year outcomes from more than 4500 patients, physicians can feel confident in simplifying their clinical decision-making strategy.
DEFINE FLAIR
p<0.001
iFR Swedeheart
p<0.0001
Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation
Primary objective
• Safety and efficacy of decision-making
on coronary revascularisation based on iFR vs FFR
• To assess whether the iFR is non-inferior to FFR
when used to guide treatment of coronary stenosis with PCI
Primary endpoint
• Major adverse cardiac events (MACE)
rate in the iFR and FFR groups at 1 year
• MACE
(combined endpoint of death, non-fatal MI, or unplanned revascularisation)
Secondary endpoints
• Death (all cause)
at 30 days, 2 and 5 years
• Death (cardiovascular)
at 30 days, 2 and 5 years
• MI
at 30 days, 2 and 5 years
• Repeat revascularisation by PCI or CABG
at 30 days, 2 and 5 years
• Cost associated
to iFR or FFR guidance
• Quality of life (QOL) in patients
included in the iFR or FFR guidance groups
• Cost savings of removing secondary investigations
by assessing/ treating non-culprit ACS at the time of index presentation
Primary objective
• Compare the clinical outcome of patients assessed by iFR
with patients assessed by FFR
• Registry based randomized clinical trial
(RRCT) in SCAAR/SWEDEHEART
Primary endpoint
• All cause death
National death registry, 100% follow-up adjudication
• Myocardial infarction
• Unplanned revascularization
Revascularization not identified/planned at the time of index procedure
• Follow up: SCAAR (Swedeheart/Iceland) > 99%, Denmark follow-up in the Danish registry
Angiographic assessment by experienced observer (blinded to the randomization)
Secondary end point
• Target lesion revascularization (TLR) Similar to “unplanned revascularization” but on a lesion level • Assessment of discomfort during the procedure (none/mild/moderate/severe) • Rates of revascularization • Restenosis, stent thrombosis • Assessment of to what extent physiological assessment changes the clinical decision compared to angiographic information alone (anatomy vs. physiology) • Endpoint assessment at 2-5 years This is a feature list Item that is part of a feature list. Notice the connector between the three graphics to show that they are related. • Assessment of functional gain, procedural time
iFR is adopted around the world
Are you using iFR?
Watch a deep dive on these studies from Dr. Justin Davies.
1. Davies JE, Sen S, Dehbi H-M, et al. Use of the instantaneous wave-free ratio or fractional flow reserve in PCI. N Engl J Med 2017;376:1824-34.
2. Gotberg M, Christiansen EH, Gudmundsdottir IJ, et al. Instantaneous wave-free ratio versus fractional flow reserve to guide PCI. N Engl J Med 2017;376:1813-23.
3. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018.
4. An iFR cut-point of 0.89 matches best with an FFR ischemic cut-point of 0.80 with a specificity of 87.8% and sensitivity of 73.0%. (From ADVISE II and iFR Operator's Manual 505-0101.23)
5. Data on file at Philips