Shanghai, China, December 1, 2020 — Recently, Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®) held the virtual interim meeting for the TARGET SAFE study – a MicroPort® sponsored study designed to evaluate the duration of dual antiplatelet therapy (DAPT) in patients with high bleeding risk after their percutaneous coronary intervention (PCI) with MicroPort® Firehawk® Stents.
The Firehawk® Stent has a unique single-sided grooved and targeted drug-eluting design, which significantly reduces the amount of drug used—one-third of the drug load required by comparable products—without compromising effectiveness. It also contains the minimum-load absorbable polymer, combining the advantages of a drug-eluting stent and a bare-metal stent, and thus providing a scientific rationale for postoperative one-month DAPT for patients with high bleeding risk.
During the virtual meeting, which was moderated by Zheng Ming, the First Vice President of the MicroPort® Clinical Science & Medical Affairs, investigators and experts from more than 20 clinic centers and divisions across China were invited to share their professional insights and experience.
At the meeting, Academician Han Yaling, from the General Hospital of Northern Theater Command of the Chinese People’s Liberation Army (PLA), who is leading the study as the principal investigator, introduced the recommendations from relevant guidelines and the latest research findings of the one-month DAPT regimen. She commented that, “growing evidence has demonstrated that significant reductions in the risk of bleeding events are achievable for high bleeding risk patients under one-month DAPT regimen, without increasing the occurrence of ischemia-related cardiovascular events.”
Academician Han compared the definition of high bleeding risk between TARGET SAFE study and 2019 Academic Research Consortium for High Bleeding Risk (ARC-HBR), confirming the definition of HBR in TARGET SAFE study meet the scientific requirements. Academician Han concluded: “The safety and effectiveness of one-month DAPT in patients with a high bleeding risk requires additional evidence-based medical support. The design of TARGET SAFE study is scientifically sound. Its interim safety data has been audited by DSMB. The overall risk of the clinical study is manageable.”
During the meeting, Prof. Zhao Xin from the General Hospital of Northern Theater Command of the Chinese People’s Liberation Army (PLA) noted that the patients enrolled at the Northern Theater Command General Hospital had complex lesion conditions, with a high proportion of subjects complicated with multi-vessel lesions or multiple factors causing high bleeding risk. Yet, the number of subjects who experienced serious adverse events and endpoint events was minimal, demonstrating that the safety of the current TARGET SAFE is manageable.
Zheng Ming summarized the meeting, stating, “Upon the success of the TARGET SAFE clinical study, the Firehawk® Stent can be better applied in the clinical settings, further improving the treatment options in the field of coronary intervention and reducing the adverse events in patients with high bleeding risk. In the future, MicroPort® will continue to steadily advance its global line of clinical research studies to provide patients with safer and more effective cardiovascular interventional solutions backed by a wealth of global clinical research data.’
About the TARGET Safe Study
The TARGET SAFE Study is a prospective, double-blind, non-inferiority, multi-center and randomized controlled clinical trial designed to evaluate the duration of dual antiplatelet therapy (DAPT) in patients with high bleeding risk after their percutaneous coronary intervention (PCI). The study is expected to enroll 1,720 patients with high bleeding risk for primary coronary artery disease. Patients will be randomized into a one-month DAPT therapy group and a six-month DAPT therapy group right after having their Firehawk® Rapamycin Target Eluting Coronary Stent System (“Firehawk®”) implantation successfully to compare the clinical safety and effectiveness of the two postoperative DAPT regimens. The primary endpoint of TARGET SAFE is the Net Adverse Cerebral and Cardiovascular Event (“NACCE”) at 12-month post index procedure.