Paris, France, 20 May 2022 — Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®) recently announced the results of their TARGET STEMI OCT China clinical study for its Firehawk® Rapamycin Target Eluting Coronary Stent System (Firehawk®) at the Euro-PCR 2022 conference, held in Paris. Led by Prof. Ling Tao of Xijing Hospital, the study was conducted on a population of patients with high-risk ST-elevation myocardial infarction (STEMI). According to the published OCT data of the primary endpoint at 6-month OCT follow-up, the 6-month in-stent neointimal thickness on Firehawk® was non-inferior to Xience, which was used in the control group. This study further demonstrates that Firehawk® can achieve rapid healing with equal or better safety and efficacy at the world’s lowest dosage — one-third of that of competing products, even when used in high-risk, complex patients.
TARGET STEMI OCT China, a prospective, multicenter, randomized, controlled study in a population of patients with high-risk STEMI, is one of the TARGET global clinical studies for MicroPort®’s Firehawk® family stent. The subject enrollment started in March 2019 and was completed in October 2020, with a total of 44 patients enrolled from three hospitals in China. The results of the 6-month OCT follow-up showed that the study has achieved its primary endpoint of stent strut neointimal thickness in OCT at 6-months.
The stent strut neointimal thicknesses at 12-months were 73.03 ± 33.30 µm and 78.96 ± 33.29 µm for Firehawk® and Xience treatment groups, respectively (Pnon-inferiority <0.001), demonstrating that the neointimal thickness on Firehawk® at 6-months was non-inferior to that on the Xience stent. Angiographic and OCT data at the 6-month follow-up of secondary endpoints also showed that the Firehawk® stent that was used in the experimental group was comparable to the Xience group in terms of the percentage of complete strut coverage, percentage of malapposed struts, in-stent late loss, and in-segment late loss. Additionally, no cardiac death, target vessel infarction events, or stent thrombosis occurred in either group at the 12-month clinical follow-up. The manuscripts of the study have been accepted by the Journal of Frontiers in Cardiovascular Medicine.
Prof. Tao said, “There is a lack of similar OCT studies due to the difficulty of conducting OCT investigations in patients with high-risk STEMI, as individuals must be enrolled within 12 hours of the onset of symptoms. Data from this trial is very promising for the safety and efficacy of Firehawk® stents. We are pleased to see the excellent OCT data in this study, which provides compelling evidence for vessel rapid healing in high-risk STEMI patients.”
Firehawk® is a drug-eluting stent (DES) featuring strut in-groove coating and precision target drug-releasing patent technology. It combines the advantages of the bare metal stent and drug-eluting stent, with nearly 600 grooves evenly cut in the hair-thin but extremely hard CoCr alloy. It allows for the precise injection of drugs into the micro-grooves by means of a fully automatic, 3D-printed, micro-groove filling, ensuring the effectiveness of the drug while significantly reducing the drug loading. The stent features the low restenosis rate of drug-eluting stents, as well as the extremely low late thrombosis rate of bare metal stents. By gradually releasing 90% of the drug at the lowest concentration in 90 days, it achieves accurate drug release in a "targeted, timed, and quantitative" way.
Dr. Qiyi Luo, Chief Technology Officer of MicroPort®, stated, “We are very pleased to see that the TARGET STEMI OCT China study has met its primary endpoint, which is yet another testament to the effectiveness of Firehawk®. I believe this is attributable to the innovative and unique design of the grooves on Firehawk®’s stent and its fully absorbable polymer coating. All these merits have far-reaching implications for the interventional treatment of complex lesions.”
In addition to the TARGET STEMI OCT China study, MicroPort® will continue to advance a series of TARGET global studies of the Firehawk® family stent. Currently, MicroPort® is actively enrolling subjects for the global, prospective, multicenter, randomized, controlled TARGET IV NA study, which is expected to complete enrollment in 2022. This will help lay the foundation for approval of Firehawk® in the U.S., Japan and Canada. Also in 2022, the company is expected to publish the five-year long-term follow-up results of the TARGET AC study – a randomized, controlled clinical study of the Firehawk® stent that has involved multiple countries in Europe. TARGET DAPT studies on shortened dual-antiplatelet therapy (DAPT), which include the large-scale randomized controlled TARGET DAPT study in a near ‘real-world’ setting, completed enrollment in April 2022.
About Shanghai MicroPort Medical (Group) Co., Ltd.
Shanghai MicroPort Medical (Group) Co., Ltd. is a subsidiary of MicroPort Scientific Corporation (MicroPort®, stock code: 00853.HK). As a leader in high-end innovative medical solutions, MicroPort® places emphasis on the human dimension while integrating the pursuit of perfection and innovation into the corporate DNA. In the Future, MicoPort® will continue to steadily promote the target global clinical research program, enrich the cardiovascular interventional therapy product line with the support of accumulated clinical research data, and provide patients with more high-quality and inclusive integrated solutions.