MicroPort Scientific on Friday announced three-year results from the TARGET AC study that it says affirms the long-term safety and effectiveness of its Firehawk rapamycin target eluting coronary stent system. The findings were presented at the PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), and were also published in EuroIntervention.
"These long-term data can be seen to provide clinicians and patients with additional confidence as to the sustained benefits of Firehawk," the company stated. According to MicroPort, the stent is designed to minimise polymer burden and reduce drug concentrations in the vessel wall.
The TARGET AC trial, which ran from December 2015 and October 2016, enrolled 1653 patients in Europe with symptomatic coronary artery disease, including those drawn from a real-world treatment population. Participants were randomised to treatment with the Firehawk stent or Abbott's Xience family everolimus-eluting stent. In 2018, MicroPort reported  that the primary endpoint of non-inferiority for Firehawk versus Xience was met, with a 12-month target lesion revascularisation failure (TLF) rate in the intent-to-treat population of 6.1% versus 5.9%, respectively.
In the updated results, MicroPort said that after two and three years of follow-up in the dual-antiplatelet (DAPT) treatment subgroup, the safety and effectiveness of the Firehawk stent was non-inferior to Xience. In terms of the need for any revascularisation procedure, no significant difference was observed between the two groups at three years, with rates of 15.1% for Firehawk and 15.3% for Xience. MicroPort added that two-year results also showed that the incidence of TLF in the DAPT interruption subgroup was lower for Firehawk, and that the Firehawk stent group had a "lower trend" than the Xience arm.
Meanwhile, MicroPost said the data showed a "low" incidence of stent thrombosis at three years in both groups. The company noted that the rate of very late stent thrombosis after one year of treatment was 0.8% in the Firehawk group, versus 1.4% for Xience.