Yinchuan, China – On April 20, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted the First Investigator Meeting for the pivotal clinical study TARGET DAPT Trial of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), a key study on shortening the duration of dual antiplatelet therapy ("DAPT") after DES implantation in patients undergoing percutaneous coronary intervention ("PCI"). Around 34 investigators from 30 sites attended the meeting.
The TARGET DAPT clinical study is a prospective, multi-center, randomized controlled clinical under the leadership of Academician Ge Junbo of Zhongshan Hospital of Fudan University. This trial aims to assess the safety and effectiveness of three-month versus 12-month dual antiplatelet therapy in patients undergoing PCI with Firehawk® implantation. The study plans to enroll about 2500 subjects in around 40 hospitals in China. All subjects met the inclusion criteria will be 1:1 randomized into the trial, and those with successful Firehawk® implantation will have the same opportunity of distribution into the three-month or 12-month of DAPT group after randomization. The primary study endpoint is net adverse clinical and cerebral events ("NACCE") rate at 18 months, the secondary endpoints include the incidence of major adverse cardiovascular and cerebral events ("MACCE"), all-cause mortality, major bleeding (BARC definition), as well as the economic endpoint, that is the cost and benefit ratio of subjects at 18 months after the randomization. Subjects in TARGET DAPT will be followed up for 36 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, MicroPort® Chief Marketing Officer Bo Peng delivered speeches on behalf of MicroPort®. Bo Peng said: "MicroPort® is the first domestic company independently develops and manufactures products used in coronary interventional treatment. As the leading coronary medical device provider in China, MicroPort® rapidly develops to a global medical device company within 20 years and its third-generation Firehawk® offers ideal solution for complex lesions. According to our calculation, if we assume shortening the duration of DAPT to three months after DES implantation is safe, then it will save 4.8 billion yuan medical cost for patients and the government compared with the need for standard dual antiplatelet therapy, based on the number of 700,000 PCI cases in the whole country in 2017. If the assumption is proven in the TARGET DAPT clinical trial, it will bring huge health economic benefit to the society."
Afterwards, 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 17,000 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 substudy clinical of TARGET AC involving 21 hospitals in 10 European countries 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®. It provides strong theoretical basis for shortening the duration of dual antiplatelet therapy after DES implantation in PCI patients.
During the meeting, Professor Feng Zhang of Zhongshan Hospital introduced the protocol of TARGET CTO study, including its background, the latest guideline, design rationale, the inclusion and exclusion criteria, pre-, intra- and post-operative medication requirements, the stage definition and pre-defined intercurrent follow-up angiography. He discussed about these details with the investigators in attendance. In the end, several investigators in attendance offered suggestions for the protocol.
Professor Feng Zhang introduced Silber score, a new scoring system for quantifying the quality of clinical trials in the field of cardiovascular medicine and the evidence strength of evidence-based medicine, to the attendees. Professor Feng said: "The higher the score is, the better quality the study is, and the more reliable the study result will be. If a clinical study scores to 10 points, that means it is a perfect clinical study. The Silber score of TARGET DAPT clinical trial reached nine points, which signified that it is a highly scientific and rigorous clinical trial. It is expected that this clinical program will become a milestone among studies of using drug-eluting stents to treat coronary heart disease, to provide safe and effective treating strategy for dual antiplatelet therapy after PCI in patients with coronary artery disease. I hope all the participating sites can strictly follow the study protocol and GCP principle, and I am looking forward to seeing the completion of the patient enrollment and the release of the study results."
"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, Vice President of MicroPort® Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute. "We hope the results of the primary end point for 12-month clinical follow-up (target lesion failure) for Firehawk® TARGET AC that reflects the European real world practice will be released in this year's EuroPCR in May. We are also looking forward to seeing the completion of the patient enrollment and the result release of TARGET DAPT clinical trial, which is expected to provide strong theoretical basis for shortening the duration of dual antiplatelet therapy after DES implantation in PCI patients."
MicroPort® will continue to advance the robust series clinical research program globally, and it is expected that Firehawk® FDA IDE clinical trial will gain FDA approval in the near future. With the support of increasingly more clinical data, Firehawk® is demonstrated to have the potential to reduce the duration of dual antiplatelet therapy after stent implantation, lower the risk of bleeding from long-term dual antiplatelet therapy in patients with high bleeding risk, and cut the medical costs, to bring benefit to more patients with coronary heart diseases worldwide.