USE OF PHYSIOLOGY SIGNIFICANTLY REDUCES MAJOR ADVERSE CORONARY EVENTS
RFR clinical evidence derives from assessing over 3,500 lesions in 2,000 patients,2-6 and much of that evidence is from ILUMIEN I + PREDICT, VALIDATE RFR, IRIS-FFR and RE-VALIDATE RFR.
Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for lesion assessment has been supported by more than 600 published studies including the FAME clinical trials.7-9
When integrated into cardiac cath lab procedures, measurement of FFR has been shown to reduce the incidence of major adverse coronary events (MACE) in patients being treated for complex coronary artery disease.
The FAME study—evaluating complex lesions—examined FFR measured exclusively by the PressureWire™ Certus System. Results showed that compared to angiography alone, FFR:
- Allows more accurate identification of hemodynamically relevant stenoses7
- Reduces mortality and myocardial infarction by 34%8
- Lowers procedure and 1-year follow-up costs by 14%7
- Does not increase procedure time7
- Decreases the amount of contrast agent used7
1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Jeremias A, et al. Resting full-cycle ratio (RFR): a novel physiologic index compared to Fractional Flow Reserve (FFR) in assessing the hemodynamic severity of a coronary stenosis: ILUMIEN I + PREDICT. EuroPCR 2018.
3. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
4. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
5. Data on file at Abbott.
6. Lee J-M, et al. Physiological and clinical assessment of resting physiological indexes. Circulation. 2019;139.
7. Tonino PA, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary iIntervention. New Engl J Med. 2009;360:213-224. doi: 10.1056/NEJMoa0807611.
8. Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME study. J Am Coll Cardiol. 2010;56(3):177-184. doi: 10.1016/j.jacc.2010.04.012.
9. de Bruyne B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11), 991–1001. doi: 10.1056/NEJMoa1205361.