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1、国产雷帕霉素洗脱支架远期预后的临床研究作者:郑启东,唐礼江,江建军,杜于茜,方崇峰单位:317000温州医学院附属台州医院心内科【摘要】目的观察冠心病患者应用国产雷帕霉素洗脱支架后临床不良心血管事件(majoradversecardiacevent,MACE)包括心源性死亡、再发非致死性心肌梗死、再次血运重建的发生率。方法2003年11月至2006年12月,共入选267例患者,国产雷帕霉索(Firebird,上海微创公司)支架组145例,进口雷帕霉索(Cypher,美国强生公司)支架组122例。术后严格要求患
2、者服用阿司匹林和囉氯匹定或氯毗格雷至少12个月。通过门诊或电话随访术后患者MACE的发牛率,部分患者进行了冠状动脉造影复査。结果随访(31±ll)个月,失访患者9例(Firebird组6例、Cypher组3例),失访率3.37%。随访期间总的MACE的发生率在Firebird组10.79%、Cypher组11.76%,两组无显著性差异(P=0.95),两组冠状动脉介入治疗(PCI)术后<1年及>1年MACE分别为5.04%、7.02%和5.04%、8.08%,P<0.05;Firebird支架和
3、Cypher支架的血栓发生率分別为1.44%、1.68%,P>0.05。两组冠状动脉造影再狭窄率分別为17.6%(6/34)、19%(8/42),无显苦性差异。结论远期临床随访结果表明,国产Firebird支架与Cypher支架临床心血管事件、支架内血栓的发生率均较低,两组无显著性差异,两者的安全性与有效性相似。延长联合抗血小板治疗时间很有必要。【关键词】药物洗脱支架临床心血管事件支架内血栓[Abstract]ObjectiveToobservethemajoradversecardiacevents(MAC
4、Eincludingcardiacdeath,non-fatalmyocardialinfarctionortargetvesselrevascularization)rateinpatientsimplantedwithrapamycin-elutingstents(Firebird).MethodFromNovember2003toDecember2006,atotalof267consecutivepatientswithcoronaryarterydiseasewererandomizedtoFire
5、bird(n=l45,Firebirdgroup)andCypher(n=122,Cyphergroup)stenttreatment.Fullyantiplatelettherapywasperformedfor12monthsafterpercutaneouscoronaryintervention.Follow-upwasdonebytelephoneorinterviewatclinic.Asmallproportionofpatientswasfollowedupbyangiography.Resu
6、lts258patientswerefollowedupfor(31&plusnin;ll)months,with9patients(3.37%)losttofollow-up,including6inFirebirdstentsgroupand3inCypherstentsgroup.MACEwas10.79%,11.76%inFirebirdandCyphergroup,respectively.TherewasnodifferenceofMACEbetweenthetwogroups(P=0.95).T
7、herewerenodifferencewithrestenosisafterPCIbetweenthetwogroups,whichwere17.6%(6/34)and19%(8/42)inFirebirdandCyphergroups,respectively.ConclusionTherewerealowerMACEincidentrateinFirebirdgioupandCypherstentinggioup,andnostatisticaldifferencebetweenthetwogroups
8、.FirebirdstentisanalternativeoneforPCIwitthesameefficacyandsafety.Itisimportantthatstandardantiplatelettherapyshoulebeprolnged.【Keywords]Drug-elutingstentClinicalmajoradversecardiaceventsStentthrombosi