FUTURE-II Trial Evaluates MicroPort’s Firesorb Bioresorbable Scaffold

May 20, 2021—MicroPort Scientific Corporation announced that 1-year imaging and clinical results of the FUTURE-II pivotal trial evaluating the company’s Firesorb bioresorbable scaffold (BRS) were presented by Professor Bo Xu, MD, in a late-breaking trial session at the virtual EuroPCR 2021 conference. The study findings were simultaneously published online by Lei Song, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

The Firesorb BRS is the company’s next-generation, thinner-strut, poly-L-lactic acid (PLLA) backbone BRS system abluminally coated with poly-D-L-lactide mixed with sirolimus.

According to the company, FUTURE-II is a prospective, open-label, multicenter, noninferiority, randomized clinical trial comparing the safety and efficacy of the sirolimus-eluting Firesorb BRS to the Xience cobalt-chromium everolimus-eluting metallic stent (Abbott). The trial included 433 patients with de novo obstructive coronary artery disease in 28 Chinese centers.

FUTURE II is conducted in support of the registration requirements for China’s National Medical Products Administration (NMPA) approval for Firesorb.

Microport stated the following results of the trial:

• The primary endpoint of 1-year angiographic in-segment late loss (LL) was 0.17 ± 0.27 mm in the Firesorb BRS group versus 0.19 ± 0.37 mm in the Xience group (P for noninferiority < .0001). The Firesorb was noninferior to Xience for the primary endpoint of 1-year angiographic in-segment LL.
• The key secondary endpoint of 1-year proportion of covered struts assessed by optical coherence tomography (OCT) was 99.3% in the Firesorb BRS group versus 98.8% in the Xience group (P for noninferiority < .0001).
• The OCT substudy demonstrated the Firesorb BRS’s performance of strut coverage, a lower rate of “complete protruding” pattern of embedment, and fewer incomplete strut appositions at both postprocedure and 1-year follow-up, without any late discontinuity. The company noted that this indicates a better structural integrity and scaffold-vessel interaction of Firesorb BRS at this point in time.
• The 1-year rate of target lesion failure was numerically lower for patients in the Firesorb group versus Xience patients (0.9% vs 1.9%; P = .43).
• The patient-oriented composite endpoint, defined as a composite of all-cause death, all myocardial infarction, or any revascularization was superior for Firesorb at 1-year follow-up (4.7% vs 5.1%; P = .85). The individual components were similar between the two groups, and no stent/scaffold thrombosis was observed in both groups.

The Firesorb BRS is being investigated in a total 1,200 patients, which includes the FUTURE-I first-in man study, the FUTURE-II randomized controlled trial, and the FUTURE-III objective performance criteria study. These premarket studies are a requirement in order for Firesorb BRS to obtain China NMPA approval.

Prof. Xu and Professor Runlin Gao, MD, Principal Investigator of FUTURE II, are from Fu Wai Hospital, National Center for Cardiovascular Diseases, in Beijing, China.

In the company’s press release, Prof. Gao stated, “The results of FUTURE-II show that Firesorb BRS provides comparable results at 1-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.”