New results from two clinical studies, both of which were presented at EuroPCR (19–22 May, Paris, France) provide further support to the use of St Jude Medical’s fractional flow reserve (FFR) technology to optimise percutaneous coronary intervention (PCI) procedures. According to a company press release, the results—from the 15-year follow-up of DEFER study and from the CONTRAST study—contribute to the growing body of evidence supporting FFR as a valuable and important decision-making tool for physicians.
The press release reports that the 15-year follow up of the DEFER study confirms its original and five-year findings. It states that researchers found the positive benefits of decisions based on FFR guidance were sustained after 15 years, and adds that they also found the risk for a myocardial infarction was 6.5 times lower in patients where treatment was guided by FFR compared with patients in the non-FFR guided group. There were no negative effects of leaving non-significant lesions untreated.
After 15 years, DEFER researchers found stenting a non-ischaemic stenosis had no benefit compared with patients treated by standard medical therapy. In addition to a reduction in heart attacks, patients for whom revascularisation was deferred had very low rates of complications compared to patients in which lesions were treated without proof of ischaemia.
Original DEFER investigator Nico Pijls (Catharina Hospital, Eindhoven, the Netherlands.), says: “We are pleased to see the sustained benefits of this study over 15 years. We also find it quite important that there were no myocardial infarctions as a result of deferring non-significant lesions, based upon FFR guidance. This study confirms the long-term importance of using FFR to guide PCI and improve the outcome of stenting.”
In the CONTRAST study, researchers assessed FFR differently, and compared the gold standard in vascular physiologic assessment, FFR using adenosine, to resting indices (Pd/Pa and iFR) and a new approach to adenosine-free FFR; FFR using contrast medium. Contrast FFR (cFFR), also known as contrast Pd/Pa, is a new diagnostic approach where the hyperaemic effect is induced by contrast medium in place of adenosine.
The study found that cFFR provides superior accuracy compared to resting indices such as iFR or resting Pd/Pa. It also found that both Pd/Pa and iFR to offer similar rates of accuracy. In addition, the study’s researchers concluded cFFR did not add extra cost or procedure time and may be a viable option for situations where the use of adenosine is undesired or contra indicated.