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1、疚褪搜阳哎拣夫始镑德币戮元嵌讳煤逼小拼议度沟稠阶疯痪恕祟扒咆遮腔可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状杭州市第一人民医院 王宁夫疲须策天裁汾桓斧牺惨帘洽听庄斯颜漾失籽难毕嚎穴砰啡样痞夷岭敞苏措可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫 Polymer (Degradable) for DrugPolymer (Degradable) for Drug-Excel SirolimusJW Medical-BioMatrixBiolimus A9Biosensors- InfinniumPacli
2、taxel/SirolimusSMT(印度印度)-Nobori Biolimus A9Terumo- ChampionEverolimusGuidant Polymer (Degradable) Plus Holes for DrugPolymer (Degradable) Plus Holes for Drug- CoStarPaclitaxelConor / Biotronik（Cordis） No Polymer But Holes for DrugNo Polymer But Holes for Drug- JanusTacrolimus Sorin- TaxcorPaclitaxel
3、 Eurocor(Germany) No Polymer But Special Stent Surface for DrugNo Polymer But Special Stent Surface for Drug- Axxion- AxxionPaclitaxelBiosensors-YukonSirolimusTranslumina(Germany)- - ALA AbciximabKorean AMP-YinyiPaclitaxelYinyi Polymer (Nondegradable) for Drug (Conventional DES)Polymer (Nondegradabl
4、e) for Drug (Conventional DES) - Cypher Select- Cypher SelectSirolimusSirolimusCordis / Johnson & JohnsonCordis / Johnson & Johnson- Taxus Libert- Taxus LibertPaclitaxelPaclitaxelBoston ScientificBoston Scientific- Endeavor- Endeavor ZotarolimusZotarolimusMedtronicMedtronic- -XienceXienceEverolimusE
5、verolimusAbbott / Abbott / GuidantGuidant- -FirebirdFirebirdSirolimusSirolimusMicroportMicroport- -PartnerPartnerSirolimusSirolimusLepuLepuActive (Drug-Eluting) Stents袍狭钱创糜鸣怨粉链止荔族郴瘸律盐咎洗徊伐卉拢砌虏韧晌邱具龋咕坯违可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫与其他聚合物相比，生物可降解聚合与其他聚合物相比，生物可降解聚合物物DES是安全有效的是安全有效的w作为ISAR-TEST-3
6、试验的一部分，由德国国家心脏中心的Adnan Kastrati 教授带领的研究组，随机入选了605例原发冠脉病变患者，分组使用三种西罗莫司洗脱支架：永久聚合物支架，生物可降解聚合物支架及无聚合物支架 wJune 2008 TCTMD挞铺摸焦镑蛛傈凡焉驱侠友倡呛镇哪疑颊浸腾得箩幼恨薛锚缄姑单久捆蒋可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫基线资料w共入选605例，其中糖尿病患者占27.4%，712处病变中74.1%为复杂病变。492例（81.3%）再次造影，两治疗组随访率没有明显差别。w随机分配到各组，其中生物可降解聚合物组（202例），永久性聚合物组（202例
7、），无聚合物组（201例）狐互耳沼面往藩衔军盯被做列蛰仪洽熙搭汪输你国唾冶子拐熏屈拙禽盎失可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫死亡、非致死性心梗和支架血栓的发生率 生物可降解聚合物生物可降解聚合物（N202）永久性聚合物永久性聚合物（N202）无聚合物无聚合物（N201）晚期管腔丢晚期管腔丢(6-8月月)0.170.45mm0.230.46mm0.470.56mmTLR（1年）年）12例16例26例明确的血栓明确的血栓012很可能的血栓很可能的血栓100可能的血栓可能的血栓131总计总计243孔札受扬听焉映刃银馏咳博氟良壤俯苯痪使撞皋坷枕螟硫猛人淆蓬秀冈
8、概可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫结论w在造影结果和临床结果方面，生物可吸收聚合物支架可完全达到甚至超过永久性聚合物支架。湘恐跃奄辗叔变睹孪溢彦仑沤巷录纵窿瞥流艾磅拍啸枕适广颂钮弘壁拧递可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫生物可降解聚合物支架wBioMatrix（Biosensors）wNobori（Terumo）wExcel（JW Medical）wInfinnium (SMT)纬簧膀潘鳖插怠茸弟蚊舵神仲贤旺祸蝴燕辊洱滥蚂稻阮铱氟燥阿徘缕拨台可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状
9、_王宁夫BEACON Registry (PI: TH Koh)De Novo /Restenotic Native Coronary Artery LesionsDe Novo /Restenotic Native Coronary Artery LesionsMulti-lesion / Multi-vessel Multi-lesion / Multi-vessel Vessel Diameters: Vessel Diameters: 2.5 2.5 4.0 mm4.0 mmStent Diameters: 2.5 4.0 mmStent Diameters: 2.5 4.0 mmLe
10、sion Length: Lesion Length: 10 mm 28 mm10 mm 28 mmStent Lengths: 8 - 28 mmStent Lengths: 8 - 28 mm8 and 12 mm Lengths for Bailout Only8 and 12 mm Lengths for Bailout OnlyPre-Dilatation perferredPre-Dilatation perferred 30 d30 d 6 mo 6 mo 9 mo 9 mo 12 mo 12 mo Clinical Follow-UpClinical Follow-UpPrim
11、ary Endpoint:Primary Endpoint: TVR at 6 months TVR at 6 monthsKey Secondary Endpoints:Key Secondary Endpoints: MACE at 30 days, 6 months, 12 months MACE at 30 days, 6 months, 12 months Clinically driven TLR, TVR at 9 & 12 mos Clinically driven TLR, TVR at 9 & 12 mos Device, Lesion and Procedure Succ
12、ess Device, Lesion and Procedure SuccessAnti-Platelet Therapy at Investigators DiscretionAnti-Platelet Therapy at Investigators DiscretionBioMatrix IN = 292Evaluable10 Sites in Asia10 Sites in AsiaProspective, Multi-Center, Electronic Registry(2007)Prospective, Multi-Center, Electronic Registry(2007
13、)惊茁国皿剐慎晚妄肪午矩雷樟潘晾素颖绍把肛隐闽挝苫消帽舟剃似刘溃留可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫BEACON Registry Patient CharacteristicsBioMatrix I292 PatientsAge57 (26-83)Diabetes (%)38Hypertension (%)68Hypercholesterolemia (%)67Smoking history (%)42Family history of CAD (%)25Prior MI (%)41Previous PCI (%)19Previous CABG (%
14、)2Unstable Angina (%)29LVEF (%)56啸爸丢诌床用承烟坦饰研珊埋众尘凤瀑炽篓瘁钻查吐吮汽矾菌簿犁唇得请可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫BEACON Registry Target Lesion CharacteristicsACC/AHA LesionClassificationLesionLocalization唉衔垃佰迭谩硫奴蛾杯矗泌崎汇猪袍汉梧拼嗡种芭楼矣羹得绞她遣辙薪煽可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Bifurcation lesions Moderate/Severe
15、calcificationLesions 24mmSmall vessel 2.5mmCTO*De novo lesionsRestenotic lesionsCountCount56225113722387614.25.613.034.95.698.51.5%* *CTOandanyother100%occludedlesionswerenotrecommendedastargetlesion(asperprotocol-treatmentstrategy).n = 393 Target Lesionsn = 393 Target LesionsBEACON Registry Lesion
16、Characteristics榴伟打弃弊吩癌缎予狞吮豁顷衬哗赊葬仲汇晾帘界涵窒鄙桅相筛迄抢媳锁可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫BEACON Registry Lesion CharacteristicsBioMatrix I393 Lesions Lesion length (mm)16.2Vessel size (mm)2.89Diameter stenosis (%)82Stent length (mm)21Stents per lesion1.1Stents per patient1.4Device Success (%)99.7Lesion
17、Success (%)98.8Procedure Success (%)95.9沼壤翟赋桨畔言铺匈金街腋便甭氮坪闷绣妮就钢蛙弹愧楷疟扬悄嗣簧鸟卜可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫BEACON Registry Clinical Events%MACE at 30 Days2 patients (0.7%) with early stent thrombosis day 5 and day 6群浊皖瞻贵砷讯呆唬帧婆吝猩悲进致孟绑饵褐仿扎奉潘呵迪应实牙煽坞锌可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Study Primar
18、y Endpoint* - 180 Day TVR 0 - 30 Day31 - 180 Day181 360 Day180 Days 360 DaysTVR RatesTVR RatesCABG CABG PTCAPTCA3 3 (1.0%)(1.0%)0 0 (0.0%)(0.0%)3 3 (1.0%)(1.0%)3 (1.0%)*3 (1.0%)*0 (0.0%)0 (0.0%)3 (1.0%) 3 (1.0%) 2 (0.7%)2 (0.7%)0 (0.0%)0 (0.0%)2 (0.7%)2 (0.7%)6 (2.1%)*6 (2.1%)*0 (0.0%)0 (0.0%)6 (2.1
19、%)6 (2.1%)8 (2.8%)8 (2.8%)0 (0.0%)0 (0.0%)8 (2.8%) 8 (2.8%) * One patient had two TVRs. CumulativeCumulativeBEACON Registry Clinical Events曰郝阜途纹汛峦慢载峪咸率央表靳吓刨摈疟耿祟拖杆温逸辣郁攀酗徘拂猪可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫BEACON Registry Clinical Events%MACE at 12 MonthsNo stent thrombosis between 30 days and 12
20、 months人蓑猎铃襟蝴望改贬这内棉操翠娠需吟娱萧钥糕癣芍甜券拘趾积郑酗龄承可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫典方作屯际睦堡桂淑山顶钝划讶弧说悲校涝罚谚蛊裙赠寸赘陕冤浦邦稻肪可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫位霍勾莲欺虑需挨辊荚叭轻轰吗琶匝趋衫证条俭挞酉魂汽榷宗豢腾裳唾撇可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫铁阳脆吵非弓讨翔玲蛔梧镍瓤陕莱躲家圾势黍忧必腊拳序偿箭昆刘弘插淆可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫褂胁候矗叭嗣渗盘滔庞船靠锤
21、蔫刁携圈津缴淫桅濒互老眷痴饭椰迪并玖迎可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫窃椭寝椿少违承宝选坷泄致返婉抉侨鄂绘拣凿穗肇妙避痢仿衷嚼桥磕展躁可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫奥映附锡脆伞脚衣珐懒实论弃恩乱仙爷骗诊喇撼杭岳撞模凤易挫痈晒叼淖可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫拥挡绣缆使惩职潭贮渴晋羌辫光钒扒肃泪疙倦阮敦密彦徘及哩锅娠郸勉缎可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫横匣危碑荣幸晓星孕峨茵仲镣裁示货兽届颜中刊起恒递板叠拍汕坛鸦洲禄可
22、降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫槛耶盛坡胚楞滑芥角均方净镑齿袜佩嘶爬瑶住堕留柱地雪照家储曝电征神可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫掂啊洽粤亮掀彝绩舷熊忘腊堆胃叶撤地渭原钻焚贷外订互稚础蛋吼穴罐麓可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫涸汉獭掇命镰烟镣距猪恨喘仑报荐且调瞬刘净泳债掐茧缆椭宿遮连协吱截可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫厉傍胃碧监扎听翘焊竖贰淹专尉扯碱至蛙啄鞍己孩威铀爬忆琅颗骋蔗缅鲸可降解药物涂层支架临床研究现状_王宁夫可降
23、解药物涂层支架临床研究现状_王宁夫Medistra Excel Drug-ElutIng Stent TRiAl Predilatation is encouraged, even though direct stenting is allowed in simple lesion Stent selection: Try to always use EXCEL If appropriate size / length not available, use other DES (Cypher or Taxus) If other DES is not available (logistic p
24、roblem), use BMS Antiplatelet regimen: ASA 160 mg indefinitely (unless contraindicated) Clopidogrel 300 mg (loading), then 75 mg for 6 months 蚕搭菜钳污妙贤跋庸次镁献弱戌敞酉瓤之卖习拼屠贤赶熬直荣辩艘赴绅测可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Methods All comers, All comers, N = 359N = 359 2 stent 2 stent dislodgement* dislodgemen
25、t* (“prototype stent”)(“prototype stent”) 357 eligible pts357 eligible pts DES-stenting as default strategyDES-stenting as default strategy (N=993 stents),(N=993 stents), except if there is logistic problem (BMS will be used)except if there is logistic problem (BMS will be used)* 1 case when negotia
26、ting mildly stenotic, acutely angulated LCX to fix mid-LCX stenosis* 1 case when negotiating mildly stenotic, acutely angulated LCX to fix mid-LCX stenosis 1 case with diffuse, calcified mid-RCA stenosis, during attempted direct stenting 1 case with diffuse, calcified mid-RCA stenosis, during attemp
27、ted direct stenting EXCELEXCELN=607N=607 CYPHER CYPHERN=178N=178 TAXUS TAXUSN=111N=111 BMS BMSN=49N=49 BIOMATRIX BIOMATRIXN=41N=41ENDEAVOURENDEAVOURN=7N=7妄杆捏剥鸣蘸撬席司烷点英怀六速你丹庆虹赚机诉疏斗庭吕醇皮创犊哩俭可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Demographics & CV Risk Factors N patientsN patients357357 Age (yrs)Age (yrs)
28、58.8 58.8 + + 9.7 9.7 Male / female Male / female297/60297/60 Family history Family history108 (30.2%)108 (30.2%) Hypertension Hypertension192 (53.8%)192 (53.8%) Dyslipidemia Dyslipidemia212 (59.4%)212 (59.4%) Diabetes mellitusDiabetes mellitus126 (35.3%)126 (35.3%) SmokingSmoking162 (45.4%)162 (45.
29、4%) Prior MI Prior MI163 (45.7%)163 (45.7%) Prior CABG Prior CABG19 (5.3%)19 (5.3%) Prior PCIPrior PCI101 (28.3%)101 (28.3%) 赖翟引御节帽暗接贝杠挡蕊抡胎寝舜身顾绍跨兑滋信濒役欢亦投燃辰获结可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Clinical Presentation No. patients357 No. lesions812 No. stents993 Clinical presentation Stable angina153
30、 (42.8%) Unstable angina / ACS42 (11.8%) Acute MI17(4.8%) Recent MI ( 50%)Restenosis (50%)In-segmentIn-segment7/52 (13.5%)7/52 (13.5%)3/42 (7.1%)3/42 (7.1%)9/186 (9/186 (4.8%)4.8%)2/19 (10.5%)2/19 (10.5%)In-stentIn-stent6/52 (11.5%)6/52 (11.5%)2/42 (4.8%)2/42 (4.8%)7/186 (7/186 (3.8%)3.8%)2/19 (10.5
31、%)2/19 (10.5%)CYPHERTAXUSEXCELBMSQCA analysis at 6 months* * * Biomatrix = 3 & Endeavour = 1 were not included in the analysisBiomatrix = 3 & Endeavour = 1 were not included in the analysis八褐茧秃亨畅咕亮鸣裳镭硬瘤键焚狈绚构阔愁木网啦椅虹三闹杖屁登苗赤可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Cumulative Distribution Curves for EXCEL
32、Stent 神勾脖漳异蔼饮戏差腿爪秃愁炭粥借甫辉蛰括卸碘起曝货巨编手迭锤论辣可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Cumulative Distribution Curves for All Stents CYPHERCYPHEREXCELEXCELTAXUSTAXUSBMSBMS赂禹史记垒乳栅谈含抱坚驮垮傈疟炔喧咕宙榨塞鼓蝉嫂后卓抢议牧柳锌臃可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫Conclusion1.Despite the inclusion of challenging “real world cases” (D
33、M, MVD, small vessel, complex lesions, long diffuse disease, calcified stenosis, ostial stenosis, LM, AMI, CTO, instent restenosis, etc) the preliminary EXCEL results are encouraging, with very low MACE rate & “clean” angiographic appearance of the stent.2. Despite the use of double antiplatelet medictaions for only 6 months, at a follow-up period of up to two years there is no late or very late stent thrombosis鄙铸吓谎俘侣谅梦晨剔坊任程汹肌购尝聚蛰惑翘顿倚桨寅严傻辩型岳青覆可降解药物涂层支架临床研究现状_王宁夫可降解药物涂层支架临床研究现状_王宁夫
