A Randomized Comparison Between Biodegradable Polymer Sirolimus-Eluting Stents And PARTNER Stents For Patients With Coronary Artery Diseases

PrefaceDrug eluting stent(DES) can reduce the rate of instent restenosis of percutaneous coronary intervention(PCI),but recent studies have showed that late thrombosis can increase the rate of late major adverse cardiac events,which result in general consideration in its salty and long effectiveness.Virmani et al thought the residual polymer is one of the major causes for vascular wall inflammation,endothial covering and thrombosis.Our study is to observe the difference of cardiovascular event occurrence rates,restenosis rates and in-stent late loss(ISLL) between patients implanted with biodegradable polymer sirolimus-eluting stents and PARTNER stents.Materials and MethodsA randomized and controlled study enrolled 103 patients,51 in biodegradable polymer sirolimus-eluting stents group(test group) and 52 in PARTNER stents group(control group).There were no differences in ages,gender,smoking,diabetes, hypertension,high cholesterol,acute myocardial infraction(AMI),old myocardial infraction,past history of percutaneous coronary intervention(PCI) and left ventricular eject fraction between the two groups.There were also no differences in counts of coronary arteries lesions,target vascular distribution,types and length and stenosis extent of target lesions between the two groups,and the mean length and diameter and the largest expansion pressure of implanted stents were also not different between the two groups.All patients oral clopidogrel 75mg/d and aspirin 100mg/d at least 3 days before PCI.Fully anti-platelet therapy was performed for 9 months after PCI.Clinical follow-up about major adverse cardiac events(MACE),including death,AMI, revascularization of target lesions,recurrent myocardial ischemia,was done by telephone or clinic after PCI 1,3,6 and 9 month respectively.Follow-up by coronary angiography(CAG) was done after PCI 6-9 month.ResultsAll patients were followed up for 9 months.68.0%(70/103) patients in the two groups were followed up by CAG,among them 94.1%patients in test group(48/51) and 42.3%patients in control group(22/52).No death,AMI and in-stent thrombosis occurred in the two groups.A patient in test group occurred cerebral hemorrhage and interrupted anti-platelet therapy.The restenosis rates of test group and control group were 5.88%(3/51) and 3.85%(1/26),and there were no the difference between the two groups(P＞0.05).There were 3 patient re-PCI due to restenosis of target lesions in test group and none re-PCI in control group,and there were no the difference between the two groups.(P＞0.05) ISLL were 0.395±0.529mm and 0.328±0.409mm in test group and control group,and there were also no the difference between the two groups(P＞0.05).ConclusionShort-term follow-up suggested that there were no death,AMI and in-stent thrombosis occurred in the two groups,the cardiovascular event occurrence rates both had safety and effectiveness.And coronary angiography follow-up revealed no difference in restenosis rates and in-stent late loss between the two groups.