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.
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iFR Outcome Data
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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.
* 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.
Watch a deep dive on these studies from Dr. Justin Davies.
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