Paris, France, June 26, 2020 – MicroPort Scientific Corporation ("MicroPort®") announced today the three-year results from the TARGET AC study for its Firehawk Rapamycin Target Eluting Coronary Stent System (“Firehawk®”). The long-term clinical data results from the TARGET AC study was presented for the first time during the PCR e-Course, hosted by the organizers of EuroPCR 2020 which was cancelled earlier this year due to the Covid-19 pandemic.
Results showed that at the two and three-year follow-up time point in the dual-antiplatelet (DAPT) treatment subgroup, the safety and effectiveness of the Firehawk® stent was non-inferior to the Xience stent, one of the most extensively studied stent platforms. At three years, no significant difference was observed between the two groups in terms of the need for any revascularization procedure for Firehawk® and Xience respectively (15.1% vs. 15.3%, p = 0.90). The two-year results showed that the incidence of target lesion revascularization failure rate in the DAPT interruption subgroup was lower for Firehawk® , and the Firehawk® stent group had a lower trend than the Xience group.
The incidence of stent thrombosis in the TARGET AC three-year results was low in both groups; very late stent thrombosis after one year of treatment, 6 cases (0.8%) in the Firehawk® group and 11 cases (1.4%) in the Xience group (P = 0.24), with the number of cases of very late stent thrombosis in the Xience group nearly double that of the Firehawk® group (0.8% vs 1.4% p = 0.24).
Firehawk is designed to minimize polymer burden and reduce drug concentrations in the vessel wall. The TARGET AC clinical trial enrolled patients in a large-scale, randomized, controlled trial including patients from a real world treatment population. These long-term data can be seen to provide clinicians and patients with additional confidence as to the sustained benefits of Firehawk®.
The trial results were presented during the interviews and round table channel session by Professor William Wijns, the current chairman of PCR, Professor Alexandra Lansky, Yale University, and Professor Andreas Baumbach, the current chairman of The European Association of Percutaneous Cardiovascular Interventions (EAPCI). The three-year results of the TARGET AC were also published online in the medical journal EuroIntervention.
The Firehawk TARGET AC clinical study was the first study where MicroPort has been recognized by the international interventional cardiology community, having been published in The Lancet and while also having been published in the Journal of the American College of Cardiology.
About the TARGET AC study
The clinical design is a prospective, multi-center, randomized controlled study of the real world population in Europe. The primary endpoint is the 12-month target lesion revascularization failure rate (TLF). The study began in December 2015 and ended in October 2016, and enrolled 1,653 patients in 21 hospitals in 10 European countries, including the United Kingdom, Spain, France, Italy, Belgium, Netherlands, Germany, Austria, and Denmark. In addition, there were smaller subset studies with 50 patients in OCT subgroup and 176 patients in quantitative coronary angiography (QCA) subgroup (13 months follow-up). All patients included in the study will be followed up to 5 years.
The Firehawk® stent by MicroPort is the world's first independently developed and commercially successful stent with a groove in the stent strut surface and a targeted release technology. The unique design of Firehawk® where the amount of drug load used is greatly reduced (the drug load is 1/3 of similar products), and the absorbable polymer has the lowest polymer load compared with other biodegradable polymer drug-eluting stents in the world, combine the advantages of both drug eluting stents and bare metal stents. Through extensive, rigorous clinical study by the “gold standard” randomized controlled trial, the Firehawk® continues to increase the body of clinical evidence for safety and efficacy, further establishing its status as an elite workhorse drug-eluting stent for worldwide use. In the future, MicroPort will continue to steadily advance its global series of clinical program plans, providing patients with safe and effective cardiovascular intervention therapies with the intent of continuously enriching global clinical research data.