NEW YORK U.S.A. [October 23, 2020] — The 32nd American Transcatheter Cardiovascular Therapeutics conference (TCT 2020) kicked off as an online conference (TCT Connect) from October 14-18, 2020, providing a platform for interventional cardiovascular experts and industry insiders from more than 110 countries to share latest industry developments and academic insights. Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”) participated in the conference and unveiled several important developments in its global series of clinical studies.
MicroPort® highlighted the latest results of the clinical study FireHawk® TARGET All Comers (TARGET AC), with a focus on its three-year follow-up results and the two-year results of a dual-antiplatelet (DAPT) treatment subgroup. [1] The three-year results of the TARGET AC research provide strong evidence that the Firehawk® stent is non-inferior to the Xience stent in terms of safety and effectiveness. Both stents are comparable in terms of low target lesion failure (TLF) rates at over 12 months, as well as low rates of in-stent thrombosis in real-world populations. The two-year results of TARGET AC on the DAPT subgroup show a low TLF rate in the DAPT interruption subgroup. In addition, the TLF rate of the Firehawk® stent group is found to have a trend of lower incidence than that of the Xience group. The study was published online in EuroIntervention, the official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). [1]
Results from the clinical study COMPARE CRUSH[2], which is supported by MicroPort®, were released for the first time on October 14 2020. The large-scale, randomized and controlled study was initiated and led by Professor Georgios J. Vlachojannis, M.D., University Medical Center Utrecht, the Netherlands, with the aim of determining whether patients with ST-segment elevation myocardial infarction (STEMI) benefit from prehospital administration of crushed or whole Prasugrel pills. The trial enrolled a total of 727 patients with suspected STEMI and developed symptoms within 6 hours. These patients were randomized into two groups to receive either crushed Prasugrel or whole Prasugrel pills. The primary endpoint of this trial was to observe changes in TIMI 3 flow recovery in PCI infarct-related arteries and complete recovery of ST-segment elevation at 1 hour after PCI. The study was published online in Circulation, a leading international cardiovascular journal, for its useful and novel exploration of treatment options for patients with acute myocardial infarction. In the study, all patients in the test and controlled groups who underwent direct PCI were implanted with Firehawk® stents. Having a high risk of stent thrombosis, both the test and controlled groups show low rates of 30-day confirmed and probable stent thrombosis rates, at 0.6% and 0.7% respectively, p=0.92, with no significant difference. The result further demonstrated the safety and efficacy of the Firehawk® stent for use in high-risk cases like STEMI.
During the conference, MicroPort® also announced that the TARGET IV NA, a clinical research program for Firehawk® Rapamycin Target Eluting Coronary Stent System, will soon enroll the first patient. The clinical trial program plans to conduct, for the first time, a prospective, multi-center, large-scale, randomized, controlled trial in targeted areas before launch, enrolling patients from an approximated real-world treatment population, with a primary endpoint of twelve-month TLF rate.
As a leading high-end medical device provider, MicroPort® has been growing its global cardiovascular intervention business. A champion of evidence-based medicine, MicroPort® ensures the clinical results of almost all its core products and solutions are published in leading international academic journals. Backed by a wealth of global clinical research data, MicroPort® will continue to steadily advance its global clinical research programs to provide safer and more effective integrated cardiovascular interventional solutions for patients and physicians.
1. Yuichi Saito, M.D; Henning Kelbæk, M.D; Bo Xu, M.D; Yasin Hussain, M.D;Richard Anderson, M.D; Volker Schächinger, M.D; Ming Zheng, M.D; William Wijns, M.D;Andreas Baumbach, M.D; Alexandra Lansky, M.D, Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent: 3-Year Results of the TARGET All Comers Trial. EuroIntervention.
2. Vlachojannis GJ, Wilschut JM, Vogel RF, Lemmert ME, Delewi R, Diletti R, Waarden NWPLvd, Nuis R-J, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Mieghem NMV, Smits PC. Effect of pre-hospital crushed prasugrel tablets in patients with stemi planned for primary percutaneous coronary intervention: The randomized compare crush trial. Circulation.