Study Of Safety And Efficacy Of Biodegradable Polymer-based Rapamycin-eluting Stent (TIVOLI) In Treatment Of Acute Coronary Syndrome Patients

Objective To evaluate the safety and efficacy of biodegradable polymer-basedrapamycin-eluting stent in treatment of acute coronary syndrome by the way of contrast..Methods80patients (52males and28females，mean age65.46±7.22years) wereenrolled in study from September2011to June2012. All patients received coronaryangiogram and PCI.40patients(25males and15females，mean age68.17±3.77years)were implanted with rapamycin-eluting coronary stent(EXCEL) and40patients (27males and143females，mean age68.17±3.77years) were implanted with biodegradablepolymer-based rapamycin-eluting stent. The patients in both groups were similar withrespect to age, gender, history, the segment of lesion, the length and diameter of lesion. Allpatients were on an oral medication of300mg of aspirin and clopidogrel at the first timethree days before PCI, then after300mg continue used for one month, aspirin were take100mg q.d infinitely, clopidogrel were used75mg q.d post-PCI. Both major cardiac eventsand restenosis were observed at6months’follow-up.Results The success rates of two groups were both100%, Patients in all groupssuccessfully implanted stent. TIVOLI group, a total of68groups target lesion,47type B2complex lesions, the mean target lesion length was17.59±5.62mm, the average degree ofstenosis85.33±10.57%, the length and diameter of the average stents were33.9±13.8mmand3.2±0.5mm. In the EXCEL group, a total of73groups of the target lesion,45B2/Ctype complex lesions, the mean target lesion length18.05±5.6mm,83.58±12.47%of the average degree of stenosis, length and diameter of the average stents were32.8±15.9mmand3.3±0.6mm. Patients during hospitalization and30days after surgery without MACEin to exit the follow-up, in addition to the the TIVOLI group of patients3months due tosurgery, the Excel group1patients, three days after PCI hospital sudden death, consider forsubacute stent thrombosis formation due to the rest of the patients completed the clinicalfollow-up, with an average follow-up (6.2±0.22) months. The TIVOLI group andEXCEL group were10cases, seven cases of coronary angiography again two cases,1caseconfirmed by coronary angiography in-stent restenosis, the successful implementationtarget lesion revascularization (Target lesion revascularization TLR). TIVOLI group andEXCEL group MACE rate in the six months were7.5%and5.0%(P>0.05), nosignificant difference. The two groups of the follow-up period of the non-fatal myocardialinfarction occurred. The two groups were not found with rapamycin and its polymer-relatedadverse reactions.Conclusion Biodegradable coating rapamycin drug-eluting coronary stent(TIVOLI stent) clinical application security, short-term effect contained rapamycinbiodegradable polymer coated stent (EXCEL stents) are similar, both in reducing majoradverse cardiacevents, reduce in-stent restenosis and stent thrombosis was no significantdifference, can obtain satisfactory clinical results. Stent thrombosis is a small probabilityevent, more long-term clinical efficacy has yet to be further follow-up observation.