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  • Title: Six-month outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in treating single de novo lesions in human coronary artery.
    Author: Wu Y, Shen L, Ge L, Wang Q, Qian J, Zhang F, Yao K, Huang D, Chen Y, Ge J.
    Journal: Catheter Cardiovasc Interv; 2016 Mar; 87 Suppl 1():630-7. PubMed ID: 26864162.
    Abstract:
    OBJECTIVE: We aimed to investigate short-term outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in human coronary artery. BACKGROUND: Bioresorbable scaffolds are considered to be the fourth milestone in percutaneous coronary intervention. METHODS: Thirty patients with symptomatic ischemic coronary disease were enrolled and treated with the XINSORB scaffolds that were 3.0 × 12, 15, and 18 mm in size. The primary angiographic endpoint was late luminal loss (LLL), whereas the primary clinical endpoint was major adverse cardiac events (MACEs) at the 6 month follow-up. In a subset of 19 patients, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed at follow-up. RESULTS: The success rates of the procedure and the device were both 100%. Twenty-seven patients received angiographic follow-up. All patients were clinically assessed. Neither MACEs nor stent thrombus-related events were recorded. The percentage of diameter stenosis at follow-up was similar to that at postprocedure. In-scaffold and periscaffold LLL were 0.17 ± 0.12 and 0.13 ± 0.24 mm, respectively. No in-stent restenosis was detected. IVUS showed that the mean areas of the lumen, scaffold, and neointima at follow-up were 6.27 ± 0.69, 6.48 ± 0.70, and 0.20 ± 0.09 mm(2) , while in-device stenosis was 3.1 ± 1.3%. OCT showed that 97.9% of the struts presented a preserved box, while 2.1% had an open box after 6 months. A total of 95.9% of the struts were covered by neointima. CONCLUSIONS: This first-in-human study demonstrates the effectiveness and safety of the XINSORB scaffold in treating single de novo coronary lesions.
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