Beijing, China – On October 12, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted a symposium on the study protocol of Target SAFE, a pivotal trial of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") in high bleeding risk patients after PCI therapy. More than 30 investigators from 29 participating hospitals attended the symposium held in Beijing.
TARGET SAFE trial is a prospective, double-blind, multi-center, randomized clinical trial in high bleeding risk patients after PCI therapy. A total of 1,700 patients will be enrolled in up to 40 sites in China. Patients will be randomly assigned at the ratio of 1:1 to either one-month DAPT group or six-month DAPT group after Firehawk® coronary stent implanted successfully. The primary endpoint is net adverse clinical and cerebral events ("NACCE") at 12 months after index procedure. The second endpoints are MACCE, all cause death, major bleeding and cost-effectiveness ratio at 12 months after index procedure. The patient enrolled in TARGET SAFE trial will continue follow-up to 24 months.
The meeting was chaired by Ming Zheng, Vice President of Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute. During the meeting, Lei Jiang, MicroPort® First Vice President of Domestic Coronary Sales & Marketing, and the Principal Investigator Professor Yaling Han of the General Hospital of Shenyang Military, who is also the academician of Chinese Academy of Engineering, delivered speeches respectively on behalf of MicroPort® and the investigators. Then, Ming Zheng introduced the global clinical study programs of Firehawk® - since the launch of TARGET FIM in 2009 following the first patient enrollment, the TARGET series studies enlarged its coverage from China to Europe, Southeast Asia, North America, and South America with nearly 16,000 patients enrolled in this large-scale global clinical studies. The latest clinical outcome released include the five-year follow-up data of TARGET I RCT which showed the stent thrombus rate is zero, and the data of the OCT sub-study clinical of TARGET AC involving 21 hospitals in 10 European countries which showed the three-month stent strut cover rate was of 99.9%, demonstrating early vessel healing and excellent long-term safety and efficacy of Firehawk®.
Professor Yaling Han shared with the attendees the initial ideas and preliminary preparation of the study. She then introduced the study protocol of TARGET SAFE trial, including its background, the latest guideline, design rationale, the inclusion and exclusion criteria, pre-, intra- and post-operative medication requirements, and the definition of stage procedure and the principle of management. She discussed about these details with the investigators in attendance. Professor Shaoliang Chen, President of Nanjing First Hospital, Professor Shubin Qiao of Fuwai Hospital of Chinese Academy of Medical Sciences, and Professor Xiaodong Li of Shengjing Hospital of China Medical University also offered precious suggestions to the study protocol.
"As the third-generation of MicroPort®'s in-house developed drug-eluting stent, Firehawk® has proved to be safe and effective by clinical data due to its innovative design," said Professor Yaling Han. "High bleeding risk patients account for one fifth or one fourth of PCI patients and how to treat these patients is a big challenge for cardiovascular interventional physicians. Currently, metal stent is the primary choice however it has limitations such as high restenosis rate. Firehawk® stent has a unique groove design located on outside surface of stent. The coating on the stent is consisted of bioabsorbable polymer coating and very low dose of antiproliferative drug Rapamycin filled inside the grooves. The inside surface of the scaffold is a completely bare metal stent, and will not delay endothelial process after implantation. Compared to durable polymer stent or whole coating stent, Firehawk® stent can accelerate strut endothelialisation. The outcome of Firehawk® TARGET AC OCT sub-study shows, the struts of Firehawk® stent have completely been covered by endothelial cell, and the vascular covered by the stent has been healed to effectively reduce the occurrence rate of adverse event within three months. The process of endothelialization may be completed earlier than three months after Firehawk® stent implantation. Thus, we may conclude that Firehawk® stent can reduce neointimal proliferation and prevent in-stent restenosis as drug-eluting stent, and meanwhile, it has advantage of rapid endothelial healing as bare metal stent. This is the theoretical basis of TARGET SAFE and we expect such conclusion will be further demonstrated in the following high-quality clinical program." In particular, Professor Yaling Han emphasized that the study protocol of TARGET SAFE is the result of two years' careful discussion by the clinical team of the General Hospital of Shenyang Military and MicroPort® clinical affairs employees. "Silber score represents the quality of clinical study design and intensity of evidence-based medicine. We hope TARGET SAFE would be a study with full mark (10 score) in Silber score to make it a milestone in clinical studies of drug-eluting stents so as to provide a safe and effective treatment solution for coronary heart disease patients with high bleeding risk. All the participating sites should work strictly according to requirements of the study protocol and GCP. We are looking forward to the completion of patient enrollment and the outcome release."
"We are glad to see that Firehawk® TARGET series global clinical program is carried forward smoothly as scheduled, and we have exciting clinical follow-up outcome from both the China market and the relatively matured European market," stated Ming Zheng. "We hope the results of the primary end point for 12-month clinical follow-up (target lesion failure) and sub-study 13-month angiographic follow-up for Firehawk® TARGET AC that reflects the European real world practice will be released next year as scheduled, and we are looking forward to the completion of patient enrollment and the release of clinical results of TARGET SAFE, to further demonstrate the safety and efficacy of Firehawk® in high risk patients."
MicroPort® will continue to advance the robust series clinical research program globally. With the support of increasingly more clinical data, Firehawk® is demonstrated to have the potential to lower the risk of bleeding from long-term dual antiplatelet therapy and cut the medical costs for patients with high bleeding risk, to bring benefit to more patients with coronary heart diseases worldwide.