Three-year clinical outcomes of a sirolimus-eluting bioresorbable scaffold (XINSORB) and a metallic stent to treat coronary artery stenosis

BACKGROUND: Recent studies have shown increased risks of late target lesion failure (TLF) and thrombosis using a bioresorbable scaffold (BRS). However, the results of the ABSORB China study offered a different means of understanding the long-term performance of BRSs. We tested the 3-year clinical outcome of the XINSORB BRS in a multicenter, randomized controlled clinical trial (ChiCTR1800014966). METHODS: Eligible patients with one or two de novo coronary lesions were randomly assigned 1:1 to be treated with XINSORB scaffolds and metallic sirolimus-eluting stents (SESs). The clinical endpoints include TLF [cardiac death, target vessel-related myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)], its components, and devised thrombosis. RESULTS: Three hundred ninety-five patients were enrolled and randomized to the XINSORB (N=200) and SES (N=195) arms. The clinical 3-year follow-up included 95.5% of the XINSORB-treated patients and 92.8% of the SES-treated patients. Dual antiplatelet therapy was at 59.0% of the XINSORB-treated and 52.8% of the SES-treated patients (P=0.34). There were no significant differences in the clinical outcomes between the XINSORB and SES arms, including in TLF (4.0% vs. 6.2%, P=0.29), cardiac death (1.0% vs. 0%, P=NA), TV-MI (1.0% vs. 0%, P=NA), and ID-TLR (3.5% vs. 6.2%, P=0.19). The rate of confirmed/probable device thrombosis in the XINSORB-treated patients was only 1.0% (2/200). CONCLUSIONS: In this XINSORB randomized clinical trial, the XINSORB scaffolds and SESs showed similar efficacy and safety up to the 3-year follow-up. The rates of TLF and device thrombosis were low and comparable between the two arms.