Beijing, China, 30 June 2022 – Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”) recently released the 2-year clinical follow-up results from the pivotal FUTURE II trial of its self-developed, second-generation, fully bioresorbable vascular scaffolds system - Firesorb® Bioresorbable Rapamycin Targeted Eluting Coronary Scaffold System ("Firesorb®”).
The FUTURE II trial is a prospective, multi-center, non-inferiority designed randomized controlled trial comparing the safety and efficacy of the second-generation thinner-strut bioresorbable eluting scaffolds - Firesorb® and that of a market-leading everolimus-eluting metallic stent. The FUTURE II trial was conducted at 28 medical centers in China and enrolled a total of 433 patients with obstructive coronary atherosclerotic heart disease.
As co-principal investigator of FUTURE-II, Prof. Bo Xu from National Cardiovascular Center of China and Fu Wai Hospital, Chinese Academy of Medical Sciences, presented the 2-year results of the FUTURE II study for the first time at the 20th China Interventional Therapeutics Conference 2022.
The results of this 2-year clinical follow-up showed that the rate of target lesion failure (TLF) with Firesorb® was not significantly different from controls (3.8% vs. 3.2%, P = 0.76); the rate of clinical ischemia-driven target lesion revascularization (ID-TLR) was not significantly different from controls, (2.4% vs. 2.8%, P = 0.78); and the 2-year patient-oriented composite endpoint (PoCE) (defined as all-cause death, all myocardial infarction, or any revascularization) was similar to controls (11.3% vs. 11.6%, P = 0.93); the components of each clinical composite endpoint were also not significantly different, and no device-related thrombotic events occurred in either group.
Landmark analysis found no significant difference in the incidence of TLF from 1 to 2 years between the two groups (2.8% vs. 1.4%, P = 0.30); the rate of PoCE was similar (7.1% vs. 7.4%, P = 0.90), and no "late catch-up effect" was found for both the rate of TLF and the rate of PoCE at 1 year follow-up. It maintained the excellent outcomes at 1-year clinical follow-up, and the primary secondary endpoint of optical coherence tomography subgroup results at 1 year confirmed the excellent endothelial coverage and scaffolds strut embedding of Firesorb® with strong stent radial support and no evidence of late scaffolds strut disruption or collapse into the lumen.
Prof. Bo Xu commented: "The randomized clinical data of future II shows that the safety and reliability of Firesorb® at the 2-year traditional endpoints are fully comparable with the top bland of metal drug-eluting stents, and no late catch-up effect is found, which is a very exciting discovery. It shows that, in addition to the excellent clinical effect of drug-eluting stents, this kind of fully bioabsorbable scaffold can greatly improve the quality of life of patients. This result gives doctors more confidence in using Firesorb® to treat the patient." Prof. Bo Xu also revealed that: "Firesorb® another large-scale pivotal clinical trial, Future III, is in the 1-year follow up stage. We are looking forward to the early launch of Firesorb® for the benefit of patients."
Currently, the Firesorb® ongoing clinical studies include: FUTURE I (first-in-human trial), FUTURE II (randomized controlled trials) and FUTURE III (historical controlled studies of objective criteria). All patients’ enrolled in the future clinical trials will follow up for up to five years.
Compared with traditional permanent metal stents, bioresorbable stents are made of special biodegradable materials. These materials are expected to be completely absorbed through degradation within a period of time after implantation, allowing the patient's vascular structure and function to be completely restored to its natural physiological state. Other potential advantages include no metal stent to permanently bind the vessel without absorption, and no interference with later imaging and subsequent bypass grafting. Minimizing the thickness of the scaffolds strut while ensuring adequate radial support is the focus of research and development for the next generation of biodegradable stents.
“The 2-year results of the FUTURE II study continue the previous positive performance and further confirm the efficacy and safety of Firesorb® to be fully comparable to the world's top competing products" said Mr. Qiyi Luo, Chief Technology Officer of MicroPort®. “We are excited by this result, and it has increased people’s expectation for this new generation of biodegradable coronary scaffolds. We hope to provide patients and doctors with more choices and confidence through sustained long-term and rigorous product research and clinical research, so as to benefit more patients with coronary artery disease worldwide."
About Shanghai MicroPort Medical (Group) Co., Ltd.
Shanghai MicroPort Medical (Group) Co., Ltd. is a subsidiary of MicroPort Scientific Corporation (MicroPort®, stock code: 00853.HK). As a leader in high-end innovative medical solutions, MicroPort® places emphasis on the human dimension while integrating the pursuit of perfection and innovation into the corporate DNA. In the future, MicoPort® will continue to steadily promote the target global clinical research program, enrich the cardiovascular interventional therapy product line with the support of accumulated clinical research data, and provide patients with more high-quality and inclusive integrated solutions.