Paris, France – On May 23, 2018, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") announced primary endpoint data at 12 months and QCA angiography data at 13 months from its TARGET All-Comers ("TARGET AC") trial. The results of the TARGET AC trial demonstrated that vessels treated with the 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 TARGET AC clinical data were presented for the first time during a late-breaking clinical trials session at the Euro-PCR conference held in Paris by Dr. Andreas Baumbach, a co-principal investigator of TARGET AC trial and Professor at the St Bartholomew's Hospital in London and Chair for Device Innovation, Queen Mary University of London in the United Kingdom.
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 1,654 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 TLF (Target Lesion Failure) rate at 12 months. In addition, the trial design included an OCT (Optical Coherence Tomography) sub-study consisting of 50 patients at 3 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.
"Data from the TARGET AC trial, which included the most complex patient real world population in Europe, demonstrated exceptional performance and safety of the Firehawk® stent," said William Wijns, M.D., PhD, National University of Ireland Galway, Ireland, and principal investigator for the study. "With this European clinical data set, Firehawk® has the potential to positively impact patient care by further reducing the risk of late adverse events and the need for device-mandated prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding as well as increased patient treatment cost."
The primary endpoint of non-inferiority for the Firehawk® stent compared to the Xience family stent was met with a 12-month TLF rate in the intent-to-treat population of 6.1 percent versus 5.9 percent, respectively (pnon-inferiority = 0.004). No statistically significant differences in TLF components were observed between the two stents. The following data were also observed at 12 months post implantation for the Firehawk® stent and Xience family stents, respectively: cardiac death (1.2 percent vs. 0.9 percent, p=0.60), myocardial infarction ("MI") related to the target vessel (4.5 percent vs. 3.9 percent, p=0.59), ischemia-driven target lesion revascularization (TLR, 1.2 percent vs. 2.4 percent, p=0.08), stent thrombosis rate (ARC definite, 1.2 percent vs. 1.2 percent, p=0.99). Of note, the TLR rate was lower in the Firehawk® stent group and the stent thrombosis rate was the same for both Firehawk® and Xience family stents.
The primary QCA substudy endpoint of non-inferiority for the Firehawk® stent compared to the Xience family stent was met with an in–stent lumen late loss at 13-months in the per treat population of 0.17 ± 0.05 mm versus 0.11 ± 0.05 mm (P non-inferiority =0.024), respectively. For this QCA sub-study, there were 176 patients randomized (89 patients Firehawk®; 87 patients Xience) for a total of 184 lesions analyzed (94 for Firehawk®; 90 for Xience). Patients were followed at 13 months post implantation.
"We are extremely pleased that the Firehawk® stent met the non-inferiority primary endpoint of target lesion failure at one year and also met the non-inferiority endpoint for the QCA sub-study of in-stent late loss at 13 months compared to the Xience Stent while demonstrating excellent safety and effectiveness with low rates of cardiac death, myocardial infarction, stent thrombosis and revascularization," said Dr. Ming Zheng, Vice President, Clinical Science & Medical Affairs, for MicroPort®. "The remarkably low rates of target lesion revascularization at one year confirm the favorable outcomes associated with the innovative Firehawk® stent design."
The Firehawk® stent has been extensively studied in China in 1,261 patients through a comprehensive clinical program called TARGET, which includes TARGET First-in-Man ("TARGET FIM"), TARGET I RCT, TARGET I Long and TARGET II studies. These studies were required by the China FDA in order for Firehawk® to obtain CFDA approval which was received in January 2014. The TARGET AC clinical trial builds upon the TARGET series study program. The Optical Coherence Tomography ("OCT") data from the TARGET FIM trial and TARGET AC Trial OCT sub-study demonstrated an early healing profile with an average of 96.2% at four months and 99.9% at three months for strut coverage (new cell growth over stent struts). Importantly, the data also showed minimal neointimal hyperplasia ("NIH") formation. TARGET I RCT was a prospective, single-blind, randomized study comparing the Firehawk® Stent to the Xience V Stent, which uses a durable polymer coating. Five-year TARGET I RCT trial data demonstrated 0.0% stent thrombosis rate (control group Xience V was 0.4%) and a very low target lesion revascularization ("TLR") rate of 3.2% (control group Xience V was 4.4%). The TARGET series study program will be followed for five years.
In addition to TARGET AC, MicroPort® will continue to advance the robust clinical program supporting the Firehawk® stent with the initiation of the TARGET Short Dual Anti-Platelet Therapy ("DAPT") Study. The company has initiated two prospective studies in China for Firehawk® to assess the safety of three-month use of DAPT in patients in near real world population and one-month use of DAPT in patients for high risk bleeding undergoing percutaneous coronary intervention ("PCI"). We expect to complete the enrollment of these studies by 1H 2020.