Proven outcomes and superior value with iFR

By Philips ∙ Jun 12, 2017 ∙ 2 min read

iFR clinical data

Cardiology

Image-guided therapy

iFR patient study

iFR is the global gold standard among resting indices, with a Class IA recommendation in the ACC/AHA/SCAI and ESC Guidelines.^1,3 This is backed by clinical evidence and patient outcomes showing reduced costs, procedural time and patient discomfort.² iFR also provides advanced guidance with iFR pullback and co-registration for PCI planning throughout the entire case. Learn more about the latest iFR patient studies and view the latest 5-year outcomes update.

Article at a glance

DEFINE PCI
Objective
Trial design
Results
DEFINE FLAIR and iFR Swedeheart
Consistent patient outcomes
Superior value

DEFINE PCI

Unseen focal lesions cause residual ischemia. The DEFINE PCI study used iFR pullback 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.^3,4

Objective

Understand residual ischemia as mapped by iFR pullback after successful angiographic PCI and its implications for procedural improvement.

Trial design

Primary endpoint: rate of residual ischemia (iFR<0.90) after angiographically successful PCI (residual diameter stenosis < 50% in any treated lesion)
Multi-center, prospective study in 22 US and six international centers
N=500 patients with CAD and iFR < 0.90 in at least one coronary artery with tandem, diffuse or multi-vessel intermediate lesions
Blinded iFR pullback to assess inschemia after PCI
One year patient follow-up

Results

One in four patients with angiographically successful PCI left the cath lab with residual ischemia.
68% relative reduction in clinical events at one year 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 co-registration uncovers focal ischemia producing lesions missed visually.

DEFINE FLAIR and iFR Swedeheart

DEFINE Flair and iFR Swedeheart are 2 prospective randomized controlled studies published in the prestigious New England Journal of Medicine and combined represent the largest physiology clinical dataset with more than 4500 patients. Learn more DEFINE FLAIR, iFR Swedeheart.

Consistent patient outcomes using iFR guided strategy, as with FFR

Graph for Consistent patient outcomes using iFR guided strategy

* 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 value

Reduced costs per patient

DEFINE FLAIR and iFR Swedeheart found that on average, compared to FFR, iFR resulted in:

$896 dollars saved

Less procedural time

DEFINE FLAIR found that an iFR-guided strategy resulted in:

10% reduction in procedural time
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.

Footnotes

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.
8. Gotberg et al. The Evolving Future of Instantaneous Wave-Free Ratio and Fractional Flow Reserve. State of the Art.

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