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 mm2, 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. © 2016 Wiley Periodicals, Inc.