Biological safety of Firebird~(TM) and Taxus Express2~(TM) in the percultaneous coronary intervention of coronary artery disease:Two-year follow-up / 中国组织工程研究

ABSTRACT

BACKGROUND:Many studies have demonstrated that FirebirdTM and Taxus Express2TM can effectively reduce intrastent restenosis.However,there are few data about long-term efficacy of two stents,and reports about middle and long-term follow up are rare.OBJECTIVE:To observe the safety and biocompatibility of FirebirdTM and Taxus Express2TM in percutaneous coronary intervention(PCI) for coronary artery disease.DESIGN,TIME AND SETTING:Non-randomized concurrent control clinical observation was performed at Department of Cardiology,Hongqi Hospital of Mudanjiang Medical College from April 2005 to April 2008.PARTICIPANTS:233 patients(268 lesions) undergoing PCI were divided into FirebirdTM(n =82),Taxus Express2TM group(n =80) and bare metal stent group(n =71).METHODS:Coronary arteriography was performed through femoral artery or radial artery.Vascular inner diameter was determined using quantitative computer analysis.The patients underwent FirebirdTM,Taxus Express2TM and bare metal stenting,respectively.The patients were reexamined and followed-up using telephone every 2-4 weeks after discharging and examined using coronary arteriongraphy after 9-12 months.The follow-up lasted for 24 months.MAIN OUTCOME MEASURES:Characteristics of arteriongraphy and stenting condition of all patients;biocompatibility of stent to host;major adverse cardiac events during hospitalization and follow-up,including death,angina pectoris attacks or heart failure;coronary artery diameter decreased ≥ 50% was regarded as restenosis.RESULTS:101 stents were implanted in Firebird group,98 in Taxus Express2 group and 85 in bare metal stent group.There was no stent defluxion,dislocation,or breakage.No noticeable platelet decrease,hemolysis or white blood cell increase was found.There were no significant differences among three groups in terms of Characteristics of arteriongraphy and stenting condition.The incidence of major adverse cardiac events and intravascular restenosis in Firebird and Taxus Express2 groups was fewer than bare metal stent group(P 0.05).CONCLUSION:No specific biocompatibility responses in treatment of coronary artery diseases using FirebirdTM and Taxus Express2TM.The two drug-eluting stents are superior over bare metal stent in reducing restenosis.The safety and efficacy of two drug-eluting stents are similar.