Proven outcomes^1,2,3^{Superior value}^1,3

Proven outcomes

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.

DEFINE FLAIR & iFR Swedeheart

largest physiology clinical outcome studies

Largest physiology clinical outcomes studies

Consistent patient outcomes using an iFR guided strategy, as with FFR

Consistent patient outcomes using iFR guided strategy, as with FFR

DEFINE FLAIR

One year outcome results

iFR Swedeheart

One year outcome results

* 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.

Superior value

Reduced costs per patient³

$896 dollars saved (On average, as compared to FFR)

Less procedural time¹

DEFINE FLAIR showed a 10% reduction in procedure time using an iFR-guided strategy [p<0.01]

DEFINE FLAIR procedural time: 40.5 minutes [iFR arm] vs 45.0 minutes [FFR arm] [p<0.001]

Improved care^1,2

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

Learn more about iFR modality

Advance from PCI justification to physiologic guidance

Only Philips co-registration iFR values directly onto the angiogram, allowing you to see precisely which parts of vassel are causing ischemia

Learn more

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iFR is recognized in key industry guidelines

Only iFR has been included in both the AUC (ACC Appropriate Use Criteria)⁵ and NCDR (National Cardiovascular Data Registry).⁶
Only iFR has been designated as “Definitely Beneficial” by SCAI (Society of Cardiac Angiography and Interventions).⁷
Only iFR has received a Class 1A ESC (European Society of Cardiology) guideline.⁸

LAD deferral is safer with iFR

DEFINE FLAIR Substudy

Sen S, Ahmad Y, et al. Journal Am Coll Cardiol 2019 in press

Dr. Sayan Sen, Consultant Cardiologist, Hammersmith Hospital & Imperial College London, discusses details of the LAD sub-study of DEFINE-FLAIR

“In this study, we have clearly demonstrated that it is safe to defer on the basis of iFR. If I see a patient with an LAD lesion, I'm only reassured for medical therapy if the iFR is negative.”

Study aims

iFR and FFR results

Value of iFR and Co-registration

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.¹⁰

1 in 4 patients with angiographically successful PCI left the cath lab with residual ischemia.¹⁰

Physiologic miss took place in varying locations.¹⁰

Of the patients with residual ischemia, 81.6% were caused by an untreated angiographically inapparent physiologically focal stenosis (≤ 15 mm).¹⁰

If all focal lesions had been successfully treated, only 4.9% of patients would remain with residual ischemia, a reduction of 79%.¹⁰

1 in 4 patients with angiographically successful PCI left the cath lab with residual ischemia.¹⁰

Of the patients with residual ischemia, 81.6% were caused by an untreated angiographically inapparent physiologically focal stenosis (≤ 15 mm).¹⁰

Physiologic miss took place in varying locations.

If all focal lesions had been successfully treated, only 4.9% of patients would remain with residual ischemia, a reduction of 79%.¹⁰

Dr. Allen Jeremias, Director of Interventional Cardiology Research and Associate Director of the Cardiac Catheterization Laboratory, Director of the Physiology Core Laboratory, St. Francis Hospital, New York, and principal investigator of DEFINE PCI, discusses the study findings at ACC 2019.

Study findings: Residual ischemia

- Dr. Allen Jeremias

Can the residual ischemia be treated?

- Dr. Allen Jeremias

Role of physiologic guidance

- Dr. Allen Jeremias

DEFINE PCI TCTMD series

Find out what Drs. Allen Jeremias, Gregg Stone, Habib Samady and Manesh Patel will discuss in the TCTMD roundtable series: Is physiologic guidance the solution to residual ischemia? A closer look at DEFINE PCI.

DEFINE PCI - Experts discuss the key findings

Listen to Drs. Allen Jeremias, Gregg Stone, Habib Samady and Manesh Patel as they discuss the results of DEFINE PCI in the TCTMD roundtable: Is physiologic guidance the solution to residual ischemia? A closer look at DEFINE PCI.

Only iFR Co-registration provides provides advanced physiologic guidance to help you decide not just whether to treat, but where to treat.

iFR Co-registration is a tool that can help you see clearly and treat optimally. It helps you identify and treat the precise locations causing ischemia and use a virtual stent to predict the result.

Philips is dedicated to the advancement of physiology guided PCI. Since the introduction of hyperemia-free iFR modality in 2014, iFR has been studied in nearly 15,000 patients and used in >5,000 cath labs around the world.⁹

iFR adoption worldwide

Philips is guiding tomorrow's innovation, today.

Learn more about how the iFR outcome data, our history of building clinical evidence, and our advanced products can help you in your practice.

DEFINE FLAIR and iFR Swedeheart results presented during late-breaking session at ACC 2017, and published in The New England Journal of Medicine

Watch the late breaking presentations from Dr. Justin Davies and Dr. Matthias Gotberg here:

Watch the late-breaking presentation by Dr. Manesh R. Patel from ACC 2018:

Resources

Watch a deep dive on these studies from Dr. Justin Davies.

Download the iFR outcomes data brochure and iFR outcomes studies trial design flyer by clicking on the images below.

1. Davies JE, et al., Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.

2. Gotberg M, et al., iFR-SWEDEHEART Investigators.. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-18233.

3. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decisionmaking.” 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. Patel M, et al., ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease. J Am Coll Cardiol. 2017 May 2;69(17):2212-2241.

6. ACC CathPCI Hospital Registry.

7. Lofti A, et al. Focused update of expert consensus statement: Use of invasive assessments of coronary physiology and structure: A position statement of the society of cardiac angiography and interventions. Catheter Cardiovasc Interv. 2018;1–12.

8. 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.

9. Data on file at Philips

10. Jeremias A et al. The DEFINE PCI Trial: Blinded Physiological Assessment of Residual Ischemia after Successful Angiographic Percutaneous Coronary Intervention, presented at ACC 2019.

Proven outcomes1,2,3 Superior value1,3

Proven outcomes

DEFINE FLAIR & iFR Swedeheart

Consistent patient outcomes using iFR guided strategy, as with FFR

DEFINE FLAIR

iFR Swedeheart

Superior value

Reduced costs per patient3

Less procedural time1

Improved care1,2

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.

Advance from PCI justification to physiologic guidance

Contact information

Guidelines

iFR is recognized in key industry guidelines

LAD deferral is safer with iFR

Philips is dedicated to the advancement of physiology guided PCI. Since the introduction of hyperemia-free iFR modality in 2014, iFR has been studied in nearly 15,000 patients and used in >5,000 cath labs around the world.9

Philips is guiding tomorrow's innovation, today.

Learn more about how the iFR outcome data, our history of building clinical evidence, and our advanced products can help you in your practice. DEFINE FLAIR and iFR Swedeheart results presented during late-breaking session at ACC 2017, and published in The New England Journal of Medicine

Watch the late breaking presentations from Dr. Justin Davies and Dr. Matthias Gotberg here:

Watch the late-breaking presentation by Dr. Manesh R. Patel from ACC 2018:

Resources

Proven outcomes^1,2,3^{Superior value}^1,3

Reduced costs per patient³

Less procedural time¹

Improved care^1,2

Philips is dedicated to the advancement of physiology guided PCI. Since the introduction of hyperemia-free iFR modality in 2014, iFR has been studied in nearly 15,000 patients and used in >5,000 cath labs around the world.⁹

Learn more about how the iFR outcome data, our history of building clinical evidence, and our advanced products can help you in your practice.

DEFINE FLAIR and iFR Swedeheart results presented during late-breaking session at ACC 2017, and published in The New England Journal of Medicine