Shanghai, China, 12 May 2022 — Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®) recently announced that the TARGET DAPT study, one of the pivotal post-market clinical studies of the Firehawk® Rapamycin Target Eluting Coronary Stent System (Firehawk®), has recently completed subject enrollment.
The TARGET DAPT study is a prospective, multicenter, non-inferiority, randomized, and controlled clinical trial. It is a pivotal study that looks at the shortened dual-antiplatelet therapy (DAPT) for patients with primary coronary artery lesions implanted with drug-eluting stents (DES) in a near “real-world” scenario. The study, led by Prof. Junbo Ge of Zhongshan Hospital of Fudan University, who also serves as the principal investigator, has enrolled a total of 2,453 subjects implanted with Firehawk® have been enrolled in the study. The subjects have been randomized 1:1 to receive DAPT for 3 or 12 months after the procedure at 40 clinical research centers in China.
The study’s primary endpoint is the 18-month incidence of net adverse cardiovascular events (NACE). Secondary endpoints include major adverse cardiac and cerebrovascular events (MACCE), all-cause death, major bleeding events, and economic endpoints (such as the 18-month cost-effectiveness ratio). All subjects will receive 36 months of continuous follow-up after enrollment.
In recent years, some clinical experts and scholars in China have suggested that conventional DAPT for up to 12 months after DES implantation in patients who have previously undergone percutaneous coronary intervention (PCI) may increase the risk of clinical bleeding events. It has also been suggested that modifying postoperative antiplatelet therapy to shorten the period of DAPT could not only help reduce late complications, but also reduce medical expenditure for patients and the National health system. Highly representative of the real-world population, the TARGET DAPT study will bring great benefits to society if it achieves the expected results.
Firehawk®, independently developed by MicroPort®, is the world’s first drug-eluting stent (DES) with strut in-groove coating and precision target drug-releasing patent technology. It features both the "low restenosis rate" of drug-eluting stents and the "extremely low late thrombosis rate" of bare metal stents. With nearly 600 grooves evenly cut in the hair-thin but extremely hard CoCr alloy, Firehawk® allows for the precise injection of drugs into the micro-grooves by means of a fully automatic 3D-printed micro-groove filling. It gradually releases 90% of the drug at the lowest concentration over a 90-day period, hence achieving accurate rapamycin release in a targeted, timed, and quantitative way, contributing to treatment effectiveness while greatly lowering drug loading.
Since the initiation of the TARGET FIM study in 2009, MicroPort® has conducted a series of TARGET clinical studies for the Firehawk® family stent systems world widely. Currently, there are 27 ongoing clinical studies with around 36,500 PCI patients enrolled. These studies provide a strong foundation for the TARGET DAPT study. In addition, there are two more ongoing studies on the short-duration antiplatelet therapy, namely the TARGET SAFE for people at high risk of bleeding and the TARGET FIRST, a large randomized controlled study of DAPT therapy for people at high risk of acute heart attack, both of which are expected to complete subject enrollment by 2023.
In the future, MicroPort® will continue to steadily advance its TARGET clinical research programs around the world to provide patients with more quality and inclusive medical solutions through a more complete cardiovascular interventional product portfolio backed by a wealth of global clinical research data.
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.