San Diego, the US – From September 21 to September 25, the 30th Transcatheter Cardiovascular Therapeutics ("TCT") took place in San Diego, California, the US, gathering more than 10,000 cardiovascular interventionalists from over 100 countries and regions across the world. The event, including Presentation Theater Programs, Expert Case Reviews, and Hot Topic Sessions, served as a scientific banquet for the participants. Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") brought to TCT its innovative products in the fields of interventional cardiology, structural heart and cardiac rhythm management, and attracted great attention from a wide range of visitors at TCT 2018.
On September 22 local time, Professor Andreas Baumbach from Queen Mary University of London and Professor Alexandra Lansky from Yale University School of Medicine, who were co-principal investigators in the TARGET AC clinical study of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") conducted in Europe, took part in the "Hi Tea with Investigators from TARGET AC Trial" session at the MicroPort® booth. The TARGET AC clinical outcomes were published on the website of the world leading medical journal The Lancet on September 3 UK time. This is the first time that clinical data from a China manufactured drug eluting stent has been published in The Lancet since its first publication nearly 200 years ago. The interview at the MicroPort® booth attracted dozens of audience from across the world, which was also live streamed online and at TCT simultaneously with access to more clinicians. MicroPort® Chief International Business Officer Jonathan Chen presided over the interview, during which Professor Lansky spoke highly of the clinical study as well as the excellent performance of Firehawk® and the study outcomes. She said, "TARGET AC trial confirms that the Firehawk®, a low dose sirolimus eluting biodegradable polymer DES, is safe and effective across a broad spectrum of patients and lesion complexity." Professor Baumbach commented during the interview, "The all comers trial is a concept that you test a stent as close as to the normal cath lab as possible, with as little exclusion criteria as possible. So TARGET AC is a trial that opens up to complex procedures. Firehawk® is a stent that has all the features for everyday use: large cell for good side branches, good radial force and now with safety and efficacy data. So I think this is a workhorse stent." There was also a lively Q&A session at the MicroPort® booth, with the visitors having in-depth discussions with the two professors about the issues such as the lowest drug dosage of Firehawk® with the same efficacy against similar products, the shortened period of post-operative dual antiplatelet therapy and the range of indications of Firehawk®.
On September 23 local time, Professor Lansky analyzed the TARGET AC sub-study data during the Moderated Poster of TCT. She pointed out again that Firehawk® demonstrated safety and efficacy in a broad range of complex lesions and various kinds of indications, including diabetes, acute coronary syndrome, ST segment elevation, small vessels, long lesions, bifurcation, CTO and left main lesions. The clinicians in attendance showed strong interest in the new generation stent and gave questions, with the excellent clinical performance of Firehawk® well received.
On September 21 local time, Professor Junbo Ge, who is an academician of the Chinese Academy of Sciences and head of Department of Cardiology of Zhongshan Hospital Affiliated to Fudan University, presented in details the VitaFlow® Transcatheter Aortic Valve and Delivery System ("VitaFlow®"), which is independently developed by MicroPort Shanghai CardioFlow Medtech Co., Ltd. ("MicroPort® CardioFlow") and attracted great attention. The VitaFlow®, which comprises transcatheter aortic valve, delivery system, balloon catheter and introducer set, provides the clinicians with an integrated solution to the treatment of high-risk aortic stenosis. VitaFlow® adopts innovative design with inner and outer skirts, which effectively reduce the occurrence of paravalvular leak. The unique motorized handle delivery system provides good controls and release stability. Thus far, VitaFlow® has completed clinical trial, which was a prospective, multi-center, single-arm study, and another one-year follow-up study. The trial enrolled 110 aged patients with either high-risk severe aortic stenosis or conditions rendering open surgeries life-threatening. Of the patients, a total of 42 had bicuspid aortic stenosis. The one-year study's outcomes showed that the occurrence of all-cause mortality was as low as 2.7%, and there was no major stroke. All of the patients reported good valve function, without moderate or severe PVL. During the one-year follow-up study, good hemodynamic results and significant improvement in NYHA class (97% NYHA≤Ⅱ) were achieved. The treatment outcomes of patients with bicuspid aortic valve stenosis are similar with those who had tricuspid aortic valve stenosis. The data confirmed that VitaFlow® is able to treat severe calcified aortic valve stenosis with safety and efficacy.
On September 22 local time, Dr. Lei Song from Fuwai Hospital of Chinese Academy of Medical Sciences released the two-year clinical and angiographic follow-up results of FUTURE-I Study of Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®"). FUTURE-I Study is a prospective, single arm, First-in-Man ("FIM") clinical trial designed to evaluate the safety and efficacy of Firesorb® in the treatment of coronary heart diseases. A total of 45 patients diagnosed with single de novo coronary artery lesions (vessel size 3.0-3.5mm, lesion length ≤25mm) were enrolled in this study and randomized to two different follow-up cohorts in a 2:1 ratio. The 30 patients in cohort 1 were required to undergo angiographic, IVUS and OCT follow-ups at 6 and 24 months post-procedure, respectively; and the other 15 patients in cohort 2 will undergo same type of imaging follow-ups at 12 and 36 months, respectively.
All the subjects underwent clinical follow-up studies at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after the scaffold implantations respectively. Results: Between January and March 2016, a total of 45 patients (average age 54.4±9.3 years, male 77.8%) with 45 target lesions were enrolled. At 2 years, all patients completed clinical follow-up and target lesion failure rate was 0% with no scaffold thrombosis and the occurrence of patient-oriented composite endpoint ("PoCE", including all-cause mortality, all myocardial infarction and any revascularization) was 2.2%. There was no report of death, target vessel myocardial infarction and scaffold thrombosis. Imaging follow-up in Cohort 1 at 2 years showed that in-segment lumen loss was 0.28±0.28mm, mean restenosis rate was 3.8%, strut endothelial coverage rate was 99.7%. OCT results at 2 years showed obvious degradation of scaffolds compared with former results. The 2-year results of the FUTURE-I Study confirmed the safety and efficacy of Firesorb® in the treatment of de novo coronary artery lesions. The experts in attendance discussed the results with Dr. Song and endorsed the 2-year clinical and angiographic outcomes of FUTURE-I.
During the China Innovation session on the same day, Yaling Han, MD, academician of Chinese Academy of Engineering, from the General Hospital of Shenyang Military in China, made a speech of the latest research and development of BVS in China and pointed out that MicroPort® Firesorb® has the thinnest wall among all the BVS produced in China, showing to the international colleagues the frontier strength of China in the field of emerging science and technology.
This year marks the 30th anniversary of TCT. The meeting had a main topic of "30 Years of Groundbreaking Science, Training, and Innovation", with a focus on innovation in the rationale and thought over the development of the field. It also delved into the topic of "Where lies the future of intervention?" MicroPort® has also celebrated its 20th anniversary in 2018. As a China and even world-leading high-end medical device group, MicroPort® is always growing alongside the global cause of interventional cardiology. MicroPort® hopes to provide the best, yet affordable, integrated solution of interventional cardiology for global patients through its unremitting effort, fusion of the global clinicians' techniques and experience, and adherence to independent innovation, so as to jointly drive the continuous progress of the cause of the interventional treatment.