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June 20, 2019

Findings Presented for 2-Year Follow-Up Analysis of FFR-SEARCH Registry

June 20, 2019—Acist Medical Systems, Inc. announced that results of the 2-year follow-up analysis of the FFR-SEARCH observational registry were presented by Roberto Diletti, MD, during the EuroPCR conference held May 21–24 in Paris, France. Dr. Diletti is an interventional cardiologist at Thoraxcenter of the Erasmus Medical Center in Rotterdam, the Netherlands.

The analysis evaluated the outcomes of patients and prognostic value of postpercutaneous coronary intervention (post-PCI) fractional flow reserve (FFR) assessment, indicating that patients with a lower FFR post-PCI are more likely to experience a major adverse cardiac event (MACE).

FFR-SEARCH is a physician-sponsored study that utilized a prospective all-comers registry; more than 1,000 patients who underwent successful PCI were eligible. Developed in collaboration with Acist Medical Systems, the registry was designed to understand the correlation between post-PCI FFR values and clinical outcomes in a real-world patient population.

The company's Navvus rapid exchange microcatheter and RXi system allow the use of the physician's workhorse guidewire of choice, enabling more efficient diagnostic and post-PCI physiologic assessment because wire position is maintained throughout the procedure. The FFR-SEARCH study reported minimal time (< 5 minutes) to assess physiology after the intervention using this microcatheter-based system.

The company noted that post-PCI FFR has previously been demonstrated as a strong significant predictor of MACE. Suboptimal physiologic results can often occur when relying on angiographic imaging alone; however, further testing using an FFR pullback or intravascular imaging can identify opportunities to optimize and ultimately improve patient outcome.

Initial findings of the registry were shared after 30-day and 1-year analyses, showing that nearly 40% of patients had FFR values < 0.9 after an angiographically successful intervention. As was demonstrated in past FFR studies, there is significant mismatch between angiographic interpretation and physiologic assessment.

The company advised that although statistical significance was not shown at the 2-year primary endpoint, additional follow-on subgroup analysis—specifically for myocardial infarction and stent thrombosis events—may provide additional hypothesis-generating insights.

Joost Daemen, MD, Director of Coronary Physiology and Imaging at Erasmus Medical Center, commented in the announcement, "The results of FFR-SEARCH are in line with existing clinical evidence showing a clear trend toward increased event rates with lower FFR values following the evaluation. However, FFR-SEARCH is the first all-comer study on post-PCI physiological assessment representing the broad spectrum of patients as seen in routine clinical practice."

FFR-SEARCH lays the foundation for future post-PCI clinical studies, including the FFR-REACT randomized control trial evaluating outcomes when additional intervention is performed on patients with FFR values < 0.9 using intravascular ultrasound guidance, stated Acist Medical Systems.

On May 1, 30-day findings from the FFR-SEARCH study were published by Rutger J. van Bommel, MD, et al in Circulation: Cardiovascular Interventions.

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