• 1-Year Data Show Chinese Bioabsorbable Stent Comparable to Everolimus-Eluting Stent

    FUTURE-II trial may indicate a comeback for absorbable stents, principal investigator says

    A new generation of bioresorbable vascular scaffolds (BVS) with a thinner strut have 1-year safety and efficacy data comparable to cobalt-chromium everolimus-eluting stents (EES), according to new trial findings presented Tuesday at the EuroPCR conference.

    Ten years ago, initial studies of BVS versus metallic drug-eluting stents showed some superiority in terms of vascular restoration therapy, with recovery of vasomotion and vascular pulsatility when the scaffold was absorbed, said co-principal investigator Bo Xu, MBBS, from the National Center for Cardiovascular Diseases at the Chinese Academy of Medical Sciences.

    However, larger randomized clinical trials and subsequent meta-analysis – all powered to hard clinical endpoints – showed that BVS made of poly-lactic polymer displayed a higher rate of target lesion revascularization, and in particular a higher rate of scaffold thrombosis, when compared to metallic drug-eluting stents like cobalt-chromium everolimus-eluting stents – which led to BVS made of polylactic acid being withdrawn from the market, he noted.

    Xu noted that although BVS use is limited nowadays, the need of a bioresorbable scaffold for treating coronary lesions, leaving nothing behind and allowing the so-called vascular restoration therapy, is still very much alive.

    Xu presented late-breaking findings Tuesday from the FUTURE-II trial – a randomized trial comparing Firesorb (a new-generation thin-strut BVS made from poly-L-lactic acid) versus everolimus-eluting cobalt-chromium stent (EES).

    The team found that the second-generation Firesorb scaffold (MicroPort, Shanghai)was comparable to the Xience EES (Abbott Vascular, Chicago) on a range of clinical and safety outcomes including late lumen loss at 1 year – a primary surrogate endpoint that is known to be associated with clinical event rates.

    Trial details

    A total of 433 participants from 28 Chinese centers were randomized to receive either the Firesorb BVS (n=215) or EES (n=218). The primary endpoint was 1-year angiographic in-segment late loss (LL) powered for noninferiority testing, while the key secondary endpoint was 1-year proportion of covered struts assessed by optical coherence tomography (OCT) powered for noninferiority and subsequent superiority testing.

    The trial reported the non-inferiority of Firesorb versus EES for 1-year angiographic late lumen loss (0.17 ± 0.27 vs. 0.19 ± 0.37 mm, p < 0.001), adding that no difference was found in terms of target lesion failure between groups with a very low rate of events (1.9% vs. 3.3%, p=0.37) and no definite probable device thromboses.

    Non-inferiority was also shown in the secondary OCT endpoints, with a similar proportion of covered struts in both groups, and less incomplete strut apposition found in Firesorb versus EES group at 1 year, noted the team – adding that the latter finding may be the result of scaffold resorption.

    BVS comeback?

    The Chinese team noted that the implantation techniques used in BVS were related to adverse events rates – adding that the first-generation bioresorbable scaffolds were characterized by a thick strut of 150 microns, which made it similar to first-generation metallic DES “and therefore very much dependent by a very precise implantation technique.”

    The second-generation Firesorb scaffold has a strut thickness of only 100-125 micron, making it close to second generation drug-eluting metallic stents, noted Xu.

    He added that the results from the FUTURE-II trial may provide a new opportunity for the comeback of poly-lactic polymer-based BVS with improved physical and mechanical properties.

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