Comparison Of The Efficacy And Safety Of Polymer-free Nano Stent Versus Durable-polymer Firebird2^TM In Coronary Heart Disease With Diabetes Mellitus Patients

Objective: The aim of this study sought to evaluate the efficacy and safety between Nano polymer-free sirolimus-eluting stent(SES)and Firebird2TMdurable-polymer sirolimuseluting stent in coronary heart disease(CHD)with diabetic patients at long-term follow-up.Methods: Consecutive selection CHD patients with diabetes mellitus who had underwent PCI and randomized implantation Nano polymer-free SES(Lepu Medical Technology,Beijing,China)or the Firebird2 TM durable-polymer SES(Micro Port Medical Corporation,Shanghai,China)at the Affiliation Hospital of Qingdao University from January 2015 to December 2015.All-comers were scheduled for 12 months angiographic follow-up and 15 months clinical follow-up by phone,outpatient or re-hospitalization.The primary endpoint were major adverse cardiac events(MACE)within 15 months follow-up,a composite of all-cause death,myocardial infarction(MI)and target vessel revascularization(TVR).The secondary endpoint were in-stent late lumen loss(LLL)at 12 months angiographic followup and definite/possible stent thrombotic.Results: A total of 314 patients(Nano polymer-free SES,n=168 vs.Firebird2 TM durablepolymer SES,n=146)and 662 lesions(Nano polymer-free SES,n=351 vs.Firebird2 TM durable-polymer SES,n=311)were included in the study.Baseline data and procedural characteristics showed no significant differences between groups.The primary endpoint were no significant differences between groups at 15 months follow-up.The incidence of MACE had slightly lower in Nano group compared to Firebird2 TM group(6.55% vs 8.22%,relative risk [RR] 0.80,95% confidence interval [CI] :0.36 to 1.75,P =0.57),no significant differences with regard to all cause death(1.79% vs 1.37%,RR 1.30,95% CI: 0.22 to 7.70,P =0.92),myocardial infarction(1.19% vs 2.05%,RR 0.58,95% CI: 0.10 to 3.42,P =0.87)and target vessel revascularization(3.57% vs 4.79%,RR 0.75,95% CI: 0.26 to 2.17,P =0.59).Secondary endpoint in-stent late lumen loss was 0.32±0.23 mm for the Nano stent and 0.47±0.25 mm for the Firebird2 TM stent(P=0.03)at 12 months follow-up.Furthermore,there were no significant differences in definite/possible stent thrombosis between Nanostent and Firebird2 TM stent at 15 months clinical follow-up(0.6% vs.0.68%,RR 0.87,95% CI: 0.06-13.77,P = 1.00).Conclusion: 1.The Nano polymer-free SES showed similar safety and efficacy compared with the Firebird2 TM SES in the treatment of coronary heart disease with diabetes mellitus patients at 15 months clinical follow-up.2.Polymer-free Nano stent compared to the durable polymer Firebird2 TM stent for in-stent late lumen loss at 12 months angiographic follow-up,with significant difference between two groups,which showed that the Nano stent had obviously effect in regard to intimal hyperplasia.3.Nano stents were without durable polymer coating existence,no late polymer related adverse reactions,but compared with durable polymer Firebird2 TM polymer coating stent,the risk of late in-stent thrombosis and the need of revascularization found no significant difference between two groups.