MicroPort® Announces Successful Non-Inferior Two-Year Clinical Data for its Firehawk Drug-eluting Stent at EuroPCR 2019
Paris, France – On May 22, 2019, MicroPort Scientific Corporation ("MicroPort®, HK:0853") released the data at 24 months from its TARGET All-Comers (TARGET AC) trial. Similar to one-year primary endpoint data which has been published in The Lancet (https://doi.org/10.1016/S0140-6736(18)31649-0), the 24 months results of the TARGET AC trial demonstrated that vessels treated with Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") showed non-inferiority results when compared to vessels treated with the Xience family of drug-eluting stents. These newest clinical data were presented at EuroPCR 2019 conference held in Paris by Dr. Bo Xu, a Steering Committee member of TARGET AC trial and Director at Fu Wai Hospital, Beijing, China. This presentation will be supported by a concomitant publication in the Journal of the American College of Cardiology (JACC).
"The two-year follow-up of the TARGET All Comers study shows similar safety and efficacy profiles of the Firehawk® and Xience stents," said Dr. Bo Xu during his EuroPCR 2019 presentation concluding remarks, "The incidence of target lesion failure (TLF) beyond one year was low and comparable for both treatment arms, with a low rate of stent thrombosis in a broad all-comers population."
In the intent-to-treat population, the TLF rate's number gap between Firehawk® stent and Xience family stents is narrowed down from one year's (6.1% vs.5.9%, p=0.88) to (8.7% vs. 8.6%, p=0.92) at two year. In addition, no statistically significant differences in TLF components were observed between the two stents through two-year data between Firehawk® and Xience family stents, respectively: cardiac death (1.7 % vs. 1.1%, p=0.60), myocardial infarction (MI) related to the target vessel (5.7% vs. 5.9%, p=0.81), ischemia-driven target lesion revascularization (2.6% vs. 3.7%, p=0.21), stent thrombosis rate (ARC definite, 1.5% vs. 2.0%, p=0.99). At two years' time point, very late definite or probable stent thrombosis occurred in three patients (0.4%) in the Firehawk® group and in seven patients (0.9%) in the XIENCE group (p=0.34). Compared to one year data, the rates of myocardial infarction (MI) related to the target vessel and stent thrombosis rate (ARC definite) at two years have been flipped over. The data were also observed at 12 months post implantation for the Firehawk® stent and Xience family stents, respectively: cardiac death (1.2% vs. 0.9%, p=0.60), myocardial infarction (MI) related to the target vessel (4.5% vs. 3.9%, p=0.59), ischemia-driven target lesion revascularization (ID-TLR, 1.2% vs. 2.4%, p=0.08), and stent thrombosis rate (ARC definite, 1.3% vs. 1.3%, p=0.99).
"The Firehawk® stent has the lowest volume polymer and drug concentration among currently available biodegradable polymer drug-eluting stents in the world," said Dr. Ming Zheng, Vice President, Clinical Science & Medical Affairs of MicroPort®, "This is a tremendous milestone in the evolution of stent technology, and the Firehawk® stent is a next generation therapy designed to improve patient outcomes and ultimately reduce health care costs associated with the treatment of coronary artery diseases."
About TARGET AC study
The TARGET AC trial is a prospective, multi-center, randomized controlled clinical trial consisting of entirely European-based patients. This clinical study enrolled its first patient in December 2015 and completed enrollment of its last patient in October 2016. In total, there were 1,655 patients enrolled from 21 clinical study sites throughout Europe including countries such as the United Kingdom, France, Spain, Italy, Belgium, the Netherlands, Poland, Germany, Austria and Denmark. The trial's primary endpoint was the target lesion failure (TLF) rate at 12 months. In addition, the trial design included an Optical Coherence Tomography (OCT) sub-study consisting of 50 patients at three months post implantation and a QCA (Quantitative Coronary Angiography) sub-study consisting of 176 patients at 13 months. Patients enrolled in the TARGET AC trial will be followed for a duration of five years post implantation.
MicroPort Scientific Corporation (the "Group") is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 8 seconds in thousands of major hospitals around the world, the Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Cardiac Rhythm Management, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort® is dedicated to bringing about a people-centric SuperCluster of emerging medical technologies to provide the best yet accessible ways & means to prolong and reshape lives.
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