Evaluation Of The XINSORB Bioresorbable Sirolimus-eluting Scaffold In Treating Patient With Coronary Artery Disease By Optical Coherence Tomography

Objective:The PLLA scaffold(XDINSORB scaffold)is the first self-developed bioresorbable sirolimus-eluting scaffold(BRS)in China.We aimed to evaluate the treatment effect of XINSORB BRS by using quantitative coronary angiography(QCA)and optical coherence tomography(OCT)in the multicenter study.Methods:Twenty patients with symptomatic ischemic coronary disease were enrolled and treated with the XINSORB scaffolds under the guidance of optical coherence tomography.The scaffolds were 15,18,23,and 28 mm in length,with diameter of 3.0 or 3.5mm,respectively.The primary angiographic endpoint was late luminal loss(LLL),whereas the primary clinical endpoint was major adverse cardiac events(MACEs)at the 12-month follow-up.All subjects underwent quantitative coronary angiography and OCT examination at 12-month follow-up.The most appropriate scaffold size and length was determined by using OCT before BRS deployment.Data were analyzed systematically by experienced observers in an independent core laboratory.Results:The success rates of the procedure and the device were both 100%.19 patients received angiographic and OCT follow-up.Neither MACEs nor stent thrombus-related events were recorded.In-scaffold,Proximal and distal LLL were 0.15±0.10mm,0.18±0.08mm and 0.12±0.11mm,respectively.No in-stent restenosis was detected so far.OCT showed that the mean areas of the lumen,mean areas of scaffold,and mean areas of neointima at follow-up were 7.87±2.88 mm2,8.51±1.93mm2,and 1.42±0.14 mm2.There was a significant mean lumen area reduction between post-procedure and 12 months(9.15± 1.66 mm2 and 7.87±2.88 mm2[P<0.05]),whereas the mean scaffold area remained stable(8.58± 1.60 mm2 and 8.51±1.93 mm2,[P>0.05])between post-procedure and 12 months follow-up.The percentage of diameter stenosis at follow up was 9.79±3.88%.Slightly higher than before,but the difference was not statistically significant.OCT showed that the stent not fully covered by intima is 10.5%(2/19),fully covered stent is 84.2%(16/19).Most scaffolds were well covered.Conclusions:Comparing with the ABSORB,our result demonstrate the effectiveness and safety of the XINSORB scaffold in treating single de novo coronary lesions.