iFR is now a Class IA recommendation in the new ACC/AHA/SCAI Guideline for Coronary Revascularization based on the high level of proven evidence of its accuracy.1
Proven outcomes.1
Superior value.1,2
iFR is the global gold standard among resting indices
iFR is the global gold standard among resting indices, with a Class IA recommendation in the ACC/AHA/SCAI and ESC Guidelines. This is backed by clinical evidence and patient outcomes showing reduced costs, procedural time and patient discomfort.1,3
iFR provides advanced guidance with iFR pullback and co-registration for PCI planning throughout the entire case.
Be confident in treatment and deferral decisions with Philips iFR
Learn about the latest iFR studies: DEFINE PCI
View the latest 5-year study outcomes update: iFR Swedeheart Outcomes of a Randomized Trial
DEFINE PCI:
Unseen focal lesions cause residual ischemia
The DEFINE PCI study used iFRpullback to understand the rate and causes of residual ischemia in 500 patients undergoing contemporary PCI. Early results find that residual ischemia is common, and causes are treatable.4-5
Objective
Understand ischemia as mapped by iFR pullback and its implications for procedural improvement.
Trial design
- Primary endpoint: rate of residual ischemia (iFR<0.90) after angiographically successful PCI (residual DS < 50% in any treated lesion)
- Multi-center, prospective study in 22 US and 6 international centers
- N=500 patients with CAD and iFR < 0.90 in at least 1 coronary artery with tandem, diffuse, or multi-vessel intermediate lesions
- Blinded iFR pullback to assess inschemia after PCI
- 1 year patient follow-up
Results
1 in 4 patients with angiographically successful PCI left the cath lab with residual ischemia.
68% relative reduction in clinical events at 1 yr. follow-up among patients achieving post-PCI iFR ≥ 0.95 (p-value=0.04).
Of the patients with residual ischemia, 81.6% were caused by an untreated angiographically inapparent physiologically focal stenosis (≤ 15 mm).
The final picture is often incomplete. iFR Coregistration uncovers focal ischemia producing lesions missed visually.
1-year outcomes DEFINE PCI
-Dr. Allen Jeremias
Help identify hidden lesions DEFINE PCI
-Dr. Zaid Ali
DEFINE PCI 1-year key findings
-Dr. Gregg Stone
DEFINE PCI signal post PCI measurement
-Dr. Andrew Sharp
Follow up study -DEFINE GPS overview
-Dr. Manesh Patel
Role of physiologic guidance
-Dr. Allen Jeremias
0.89 dichotomous cut-point, backed by clinical outcomes data6
Both DEFINE FLAIR and iFR Swedeheart used a dichotomous 0.89 cut-point in their protocols to assess patient outcomes. Physicians can feel confident in simplifying their clinical decision-making strategy.
Proven outcomes
DEFINE FLAIR and iFR Swedeheart
The largest physiology clinical outcome studies
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
DEFINE FLAIR
One year outcome results
p <0.001*
iFR Swedeheart
Five year outcome results7
(HR 1.09; 95% CI: 0.90, 1.33)**
* 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.
**MACE rates at 5-years: 21.5% iFR vs. 19.9% FFR (HR 1.09; 95% CI: 0.90, 1.33)
Superior value2
Reduced costs per patient
DEFINE FLAIR and iFR Swedeheart found that on average, compared to FFR, iFR resulted in:
$896
dollars saved
dollars saved
Less procedural time
DEFINE FLAIR found that an iFR-guided strategy resulted in:
10%
reduction in procedural time
reduction in
40.5 minutes (iFR arm)
vs. 45.0 minutes (FFR arm)
[p<0.001]
Improved care
The two trials further established that an iFR-guided strategy enables a faster procedure while almost completely eliminating severe patient symptoms compared to an FFR-guided strategy.
DEFINE FLAIR reported a 90% reduction in patient discomfort.
iFR Swedeheart reported that with no hyperemic agent, you can achieve a 95.7% reduction in patient discomfort using an iFR-guided strategy.
Decide not just whether to treat, but where to treat with iFR Co-registration
Only Philips co-registers iFR values directly onto the angiogram, allowing you to see precisely which parts of the vessel are causing ischemia, and uses virtual stenting to predict treatment results.
Resources
1. Lawton J. et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. JACC. 2022;79(2):e21-e129.
2. Gotberg M, et al. Instantaneous wave-free ratio compared with fractional flow reserve in PCI: A cost-minimization analysis. Int J Cardiol 2021 1;344:54-59.
3. 2018 ESC/EACTS Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European society of cardiology (ESC) and European association for cardio-thoracic surgery (EACTS). Eur Heart J. 2018;00:1-96. Japan guidelines
4. Jeremias A et al. Blinded physiological assessment of residual ischemia after successful angiographic percutaneous coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001.
5. Patel M., et al. 1-Year outcomes of blinded physiological assessment of residual ischemia after successful PCI. JACC Cardiol Interv. 2022;15(1):52-61.
6. FDA 510k (#K173860). The iFR modality is intended to be used in conjunction with currently marketed Philips pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure.
7. Gotberg M. et al. iFR-SWEDEHEART: Five-Year Outcomes of a Randomized Trial of iFR-Guided vs. FFR-Guided PCI. Late-breaking clinical Trial presentation at TCT on November 4, 2021.
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