MicroPort® Firehawk® Shows Promising Three-month OCT Results from TARGET All Comers Trial

Paris, France – On May 17, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") announced the three-month Optical Computerized Tomography ("OCT") data from the TARGET All Comer trial, which demonstrated early vessel healing with Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") and showed non-inferiority results compared to Xience family stents.
It was the first time MicroPort® released clinical trial follow-up data based on mature international markets and completed by a third-party institution in terms of data measurement and statistics. According to the three-month OCT follow-up data, 36 patients have been followed up in three months out of the 50 initially randomized with 18 patients in each arms, for a total of 52 lesions analyzed (24 for Firehawk® and 28 for Xience). The mean neointimal thickness was 75.5μm for Firehawk® and 82.3μm for Xience (P non-inferiority <0.001, with a 90% two-sided confidence interval). This good result is also supported by a percentage of malapposed and uncovered struts of 0.0% (for Firehawk® and Xience arms).
"Firehawk® is well suited for treatment of complex lesion subsets," said William Wijns, M.D., PhD, National University of Ireland Galway, Ireland, and the principal investigator for the trial. "I am very pleased that the TARGET All Comer trial OCT sub-study three-month data demonstrated quick and optimal vessel healing. It has potential positive impact on patient care since the innovative groove design and the absorbable polymer of Firehawk® further reduce the risk of late adverse events and the need for device-mandated prolonged dual antiplatelet therapy which is often associated with a higher risk of bleeding as well as increased patient treatment cost."
TARGET All Comer is the first post-market randomized trial in 10 European countries for Firehawk®. The TARGET All Comer study started in December 2015 and completed its enrollment in October 2016. A total of 1,656 patients were enrolled, including pre-specified 50 in the OCT sub-study and 176 in a QCA sub-study (13-month follow-up).
"We are excited by these good results at three months for TARGET All Comer as they support the previous outcomes from our different trials conducted in China," stated Dr. Ming Zheng, Vice President of MicroPort® Clinical Science & Medical Affairs. "We are now waiting for the results of our primary endpoint at 12 months (Target Lesion Failure rate) for next year to support safety and efficacy results."
Firehawk® has been extensively studied in China in 1,261 patients through a comprehensive clinical program called TARGET, which includes TARGET First-in-Man ("TARGET FIM"), TARGET I CRT, TARGET I Long and TARGET II studies. In addition to the ongoing TARGET All Comer clinical research project, MicroPort® will continue to advance the robust series clinical research program, including the TARGET DAPT Trial and TARGET SAFE Trial short-range dual antiplatelet therapy program that will be respectively launched in the near future to evaluate the safety and effectiveness for the routine and high bleeding risk in patients undergoing percutaneous coronary intervention ("PCI") treatment with Firehawk® and with short double antibody therapy compared to the routine double antibody treatment. With the support of increasing more clinical data, Firehawk® is expected to bring benefit to more patients with coronary heart diseases worldwide.