Final report of the 5-year clinical outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in the treatment of single de novo coronary lesions in a first-in-human study

Abstract

BACKGROUND: We aimed to report the 5-year outcomes of XINSORB bioresorbable sirolimus-eluting scaffolds in the treatment of single de novo coronary lesions in a first-in-human (FIM) study. This is the final report of the long-term clinical outcomes of the study. Recent studies have shown that bioresorbable scaffolds (BRSs) increase the risks of late target lesion failure (TLF) and thrombosis. METHODS: In this prospective, single-arm study, eligible patients with single de novo coronary lesions were enrolled and treated with XINSORB scaffolds. The scaffolds measured 3.0 mm in diameter and 12, 15, and 18 mm in length. The clinical endpoints included TLF [cardiac death, target vessel-related myocardial infarction (TV-MI), or ischaemia-driven target lesion revascularization (ID-TLR)], its components, major adverse cardiac events (MACE), and scaffold thrombosis. RESULTS: From September 2013 to January 2014, 30 patients were enrolled and treated with XINSORB scaffolds. The procedure had a 100% success rate. None of the patients died during the 5 years of follow-up. The primary endpoint of TLF occurred in 4 patients (13.3%). Six patients were recanalized by intervention, including 4 by ID-TLR. The rate of MACE was 16.7% (5/30). One very late case of scaffold thrombosis was recorded, which led to TV-MI. No more cases of thrombosis were recorded beyond 2 years of follow-up. The rates of clinical endpoints remained steady with no changes after 3 years of follow-up. CONCLUSIONS: Considering that this FIM study was launched at an early stage of the BRS era and without optimal implantation techniques, the clinical outcomes of TLF during the 5-year follow-up were acceptable. The rate of thrombosis was relatively low.