iFR is recognized in key cardiovascular societies
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.6-7
Understand ischemia as mapped by iFR pullback and its implications for procedural improvement.
1 in 4 patients with angiographically successful PCI left the cath lab with residual ischemia.6
68% relative reduction in clinical events at 1 yr. follow-up among patients achieving post-PCI iFR ≥ 0.95 (p-value=0.04).7
Of the patients with residual ischemia, 81.6% were caused by an untreated angiographically inapparent physiologically focal stenosis (≤ 15 mm).6
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
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.
DEFINE FLAIR and iFR Swedeheart
The largest physiology clinical outcome studies
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 results⁹
(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)
DEFINE FLAIR and iFR Swedeheart found that on average, compared to FFR, iFR resulted in:
Less procedural time2 DEFINE FLAIR found that an iFR-guided strategy resulted in:
Improved care2,3 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.
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.
1. 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. 2. 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. 3. Gotberg M, et al., iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017;11:1813-1823. 4. 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 5. 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. 6. 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 7. Patel M et al. The DEFINE PCI Trial: Blinded Physiological Assessment of Residual Ischemia after Successful Angiographic Percutaneous Coronary Intervention, 1 year follow-up presented at TCT Connect 2020. 8. 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. 9. 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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