Be part of something big
The iFR outcome evidence
is finally here
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.
Consistent patient outcomes using iFR guided strategy, as with FFR.
* 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
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.
Reduced patient discomfort with less procedural time
The two trials further established that iFR offers a faster procedure while almost completely eliminating severe patient symptoms compared to FFR.
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
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Watch a deep dive on these studies from Dr. Justin Davies.
1. Data on file.
2. DEFINE FLAIR: Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation https://clinicaltrials.gov/ct2/show/NCT02053038.
3. iFR SWEDEHEART: Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome https://clinicaltrials.gov/ct2/show/NCT02166736.
4. Davies J. The future of physiology- Exploring iFR co-registration and ischemia-guided PCI, presented at TCT 2016.
5. Tonino PA, et al., FAME Study Investigators.. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24.
6. De Bruyne B, et al., FAME 2 Trial Investigators.. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001.
7. Pijls NH, et al., Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11.
