1、 lrp8KokuraKokura纪念医院的经验纪念医院的经验长病变长病变(20mm)(20mm)3.0mm3.0mm3.0mm50%50%支架支架推荐单个长支架推荐单个长支架Tan K,etal.Clinical and lesion morphologic determinants of coronary angioplasty Tan K,etal.Clinical and lesion morphologic determinants of coronary angioplasty success and complications:Current experience.J Am Co
2、ll Cardiol 1995;25:855-865success and complications:Current experience.J Am Coll Cardiol 1995;25:855-865The M-HEART investigators.J Am Coll The M-HEART investigators.J Am Coll Cardiol 1991;18:647-656Cardiol 1991;18:647-6560.3-2.90.3-2.93.0-4.63.0-4.64.7-7.04.7-7.07.1-28.07.1-28.04 4个支架个支架3 3个支架个支架2
3、2个支架个支架1 1个支架个支架再狭窄率（再狭窄率（%）病变长度（病变长度（mmmm）0 010102020303040400.20.20.30.30.40.40.50.5IVUSIVUS与造影指导下放置支架的比较与造影指导下放置支架的比较Restenosis Rate(%)Restenosis Rate(%)PTCAStentDESIn-StentIn-Stent23.523.529.729.736.736.744.344.352.452.41.01.01.71.72.62.64.14.16.56.5ControlControlSirolimusSirolimusKim YH.Long DE
4、S-II investigator,Kim YH.Long DES-II investigator,Circulation,2006;114:2148-2153Circulation,2006;114:2148-2153Very Very Late ST?Late ST?6 mo to reflect risk of ST after Plavix stoppedLate STLate STSATSAT24 hours to 30 days24 HoursST=stent thrombosis;SAT=subacute stent thrombosis;LST=late stent throm
5、bosis;VLST=very late stent thrombosis.Adapted from Bhatt.J Invasive Cardiol.2003;15(suppl B):3B.Acute STAcute ST1 to 6 months(on Plavix)ENDEAVOR IENDEAVOR IIENDEAVOR II CAENDEAVOR IIIENDEAVOR PKSingle Arm First-in-ManSingle Arm First-in-Man (n=100)(n=100)4yr4yr1:1 RCT vs.BMS1:1 RCT vs.BMS (E=598,D=5
6、99)PK(n=106)(E=598,D=599)PK(n=106)3yr3yrContinued Access Single Arm(n=296)Continued Access Single Arm(n=296)2yr2yr3:1 RCT vs3:1 RCT vs.Cypher.Cypher (E=323,C=113)(E=323,C=113)2yr2yrPharmacokinetic Study(n=43)Pharmacokinetic Study(n=43)9mo9moSingle Arm(n=99)Single Arm(n=99)9mo9moENDEAVOR JapanE-FIVEO
7、pen Label Single Arm(n=8000)Open Label Single Arm(n=8000)US Post ApprovalPROTECT 1:1 RCT vs.Cypher(E=4400,C=4400)1:1 RCT vs.Cypher(E=4400,C=4400)Open Label Single Arm Study(n=2000)Open Label Single Arm Study(n=2000)ProposedProposed Ongoing Ongoing Premarket Safety and Efficacy Package Premarket Safety and Efficacy Package*死亡、心肌梗死或重复血运重建死亡、心肌梗死或重复血运重建
