ACIST releases early-stage data on post-PCI FFR measurement outcomes
ACIST Medical Systems today released early data from the FFR-Search registry trial exploring the use of post-intervention fractional from reserve measurement on acute percutaneous coronary intervention outcomes, touting the procedure as feasible in various clinical settings.
The registry study enrolled over 1,000 consecutive patients with stable angina or acute coronary syndromes that had undergone percutaneous coronary interventions to examine the association of post-PCI FFR values on clinical outcomes at 30-days, 1 year, 2 years and 5 years. The study used ACIST’s Navvus Rapid Exchange FFR MicroCatheter to assess FFR values.
“Given that our differentiated microcatheter technology allows physicians the ability to perform rapid FFR measurements before, during and after intervention, all while maintaining their guidewire position, we feel that we are uniquely suited to address this new role of FFR compared to other FFR measurement modalities, including pressure wire-based FFR. We look forward to partnering with physicians to develop this new approach and are optimistic about the possibility of our technology playing a new role in improving outcomes,” prez & CEO Tom Morizio said in a press release.
Early data indicated that almost 50% of patients had an FFR lower than 0.90 post-PCI, and that the microcatheter-based FFR was feasible in various settings including acute coronary syndromes and ST elevation myocardial infarction.
Measurements using the ACIST Navvus FFR MicroCatheter indicated an average post-PCI-FFR value of 0.96 in a resting state and 0.91 under hyperemic conditions in 959 patients who underwent FFR measurement. Investigators noted that the use of the microcatheter only added approximately 5 minutes to overall procedure time.
“As FFR becomes more and more the standard to determine treatment approaches in patients with coronary artery disease, we are excited to see that this technology is safe, fast and easy to apply — as well as may be used to optimize longer-term outcomes after interventional procedures. The preliminary data from FFR-Search has the potential to significantly expand this technology’s role in the cath lab in the future, which is why we’re eager to see the important results of the primary endpoint at two years,” FFR-Search investigator Dr. Nicolas Van Mieghem of Rotterdamn, the Netherlands’ Erasmus Medical Center said in a prepared release.
“Based on these results, we look forward to continuing to build the evidence supporting this new role of FFR. We are eager to see how the outcomes will unfold at one, two and five years, and how we may be able to best optimize these findings through further intervention after the post-treatment FFR measurement,” FFR-Search co-investigator Dr. Roberto Diletti of the Erasmus Medical Center said in a prepared statement.
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