Paris, France, 19 May 2021— MicroPort® Scientific Corporation (MicroPort®) today have announced positive one-year imaging and clinical results of the FUTURE-II Trial, a pivotal study designed to produce the clinical data in support of the registration requirements for China’s National Medical Products Administration (NMPA) approval. Prof. Bo Xu from Fu Wai Hospital, National Center for Cardiovascular Diseases in Beijing, China, presented the results alongside the co-principal investigator in a late-breaking trial session at the EuroPCR 2021 congress, held in Paris, France. The study was simultaneously published online in JACC Cardiovascular Interventions.
Principal investigator of the FUTURE-II Trial, Prof. Runlin Gao, from Fu Wai Hospital, National Center for Cardiovascular Diseases, said, "The results of FUTURE-II show that Firesorb® BRS provides comparable results at one-year to a best-in-class drug eluting stent in traditional endpoints, providing clinicians with additional confidence to use PLLA-based BRS to treat their patients.”
Firesorb® BRS is a next-generation thinner-strut poly-L-lactic acid (PLLA) backbone BRS system abluminally coated with poly-D-L-lactide (PDLLA) mixed with sirolimus using highly accurate and precise point spraying techniques. While it functions like a metallic stent by opening an obstructive coronary artery and restoring blood flow, unlike a metallic stent, which cages the vessel, Firesorb® BRS is more flexible due to its bioresorbable material, allowing it to dissolve over time. This leaves behind a treated vessel, free of a permanent implant with the potential to flex, pulse and dilate in response to various demands on the heart based on a patient’s lifestyle and activities, such as exercise.
Qiyi Luo, MicroPort®’s Chief Technology Officer commented, "The excitement about an implantable heart device that dissolves after doing its job will continue to increase with these positive results from a randomized, controlled trial showing comparable outcomes between Firesorb® BRS and XIENCE. This data represents a significant milestone for Firesorb® BRS and highlights how this unique technology can potentially benefit patients with coronary heart disease."
The Firesorb® BRS is in the process of being investigated in an ongoing series of studies enrolling 1,200 patients, which include FUTURE-I (first-in-Man), FUTURE-II (randomized controlled trial), and FUTURE-III (objective performance criteria study). These pre-market studies are a requirement in order for Firesorb® BRS to obtain China NMPA approval.
About FUTURE-II Trial
The FUTURE-II Trial (ClinictalTrial.gov, number NCT02890160) is a prospective, open-label, multicenter, non-inferiority, randomized clinical trial comparing the safety and efficacy of a next-generation thinner-strut sirolimus-eluting bioresorbable scaffold (BRS) (Firesorb®, MicroPort, Shanghai), to a market-leading cobalt-chromium everolimus-eluting metallic stent (CoCr-EES) (XIENCE, Abbott, California). The trial included 433 patients with de novo obstructive coronary artery disease in 28 Chinese centers.
Results of the trial were as follows: the primary endpoint of 1-year angiographic in-segment late loss (LL) was 0.17±0.27 mm in the Firesorb® BRS group and 0.19±0.37 mm in the XIENCE group. (Pnoninferiority<0.0001). The Firesorb® RRS was non-inferior to XIENCE for the primary endpoint of one-year angiographic in-segment LL. The key secondary endpoint of one-year proportion of covered struts assessed by optical coherence tomography (OCT) was 99.3% in the Firesorb® BRS group and 98.8% in XIENCE group (Pnoninferiority<0.0001). The OCT substudy demonstrated that Firesorb® BRS had an excellent performance of strut coverage, a lower rate of “complete protruding” pattern of embedment, and fewer incomplete strut apposition at both post-procedure and one-year follow-up, without any late discontinuity. This indicates a better structural integrity and scaffold-vessel interaction of Firesorb® BRS at this point in time. The one-year rate of target lesion failure (TLF) was numerically lower, at 0.9%, for patients in Firesorb® group and 1.9% for patients in XIENCE group (p=0.43). The patient-oriented composite endpoint (PoCE), defined as a composite of all-cause death, all MI, or any revascularization was 4.7% for Firesorb® BRS and 5.1% for XIENCE during one-year follow-up (p=0.85). The individual components were similar between the two groups, and no stent/scaffold thrombosis (ST) was observed in both groups.