可降解药物涂层支架临床研究现状-王宁夫课件

1、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 Polymer (Degradable) for DrugExcel SirolimusJW MedicalBioMatrixBiolimus A9Biosensors- InfinniumPaclitaxel/SirolimusSMT(印度)Nobori Biolimus A9Terumo- ChampionEverolimusGuidant Polymer (Degradable) Plus Holes for Drug- CoStarPaclitaxelConor / Biotronik（Cordis） No Polymer Bu

2、t Holes for Drug- JanusTacrolimus Sorin- TaxcorPaclitaxel Eurocor(Germany) No Polymer But Special Stent Surface for Drug- AxxionPaclitaxelBiosensorsYukonSirolimusTranslumina(Germany)- ALA AbciximabKorean AMPYinyiPaclitaxelYinyi Polymer (Nondegradable) for Drug (Conventional DES) - Cypher SelectSirol

3、imusCordis / Johnson & Johnson- Taxus LibertPaclitaxelBoston Scientific- Endeavor ZotarolimusMedtronicXienceEverolimusAbbott / GuidantFirebirdSirolimusMicroportPartnerSirolimusLepuActive (Drug-Eluting) Stents与其他聚合物相比，生物可降解聚合物DES是安全有效的作为ISAR-TEST-3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

4、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 June 2008 TCTMD基线资料共入选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。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），无聚合物组（201例）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（N202）永久性聚合物（N202）无聚合物（N201）晚期管腔丢(6-8月)0.170.45mm0.230.46mm0.470.56mmTLR（1年）12例16例26例明

5、确的血栓012很可能的血栓100可能的血栓131总计243结论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。生物可降解聚合物支架BioMatrix（Biosensors）Nobori（Terumo）Excel（JW Medical）Infinnium (SMT)BEACON Registry Target Lesion CharacteristicsACC/AHA LesionClassificationLesionLocalizationBifurcation lesions Moderate/Severe calcificationLesions 24m

6、mSmall vessel 2.5mmCTO*De novo lesionsRestenotic lesionsCount56225113722387614.25.613.034.95.698.51.5%* CTO and any other 100% occluded lesions were not recommended as target lesion (as per protocol -treatment strategy). n = 393 Target LesionsBEACON Registry Lesion CharacteristicsBEACON Registry Les

7、ion CharacteristicsBioMatrix I393 LesionsLesion length (mm)16.2Vessel size (mm)2.89Diameter stenosis (%)82Stent length (mm)21Stents per lesion1.1Stents per patient1.4Device Success (%)99.7Lesion Success (%)98.8Procedure Success (%)95.9Medistra Excel Drug-ElutIng Stent TRiAl Predilatation is encourag

8、ed, 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 problem), use BMS Antiplatelet regimen: ASA 160 mg indefinitely (unless contraindic

9、ated) Clopidogrel 300 mg (loading), then 75 mg for 6 months Methods All comers, N = 359 2 stent dislodgement* (“prototype stent”) 357 eligible pts DES-stenting as default strategy (N=993 stents), except if there is logistic problem (BMS will be used)* 1 case when negotiating mildly stenotic, acutely

10、 angulated LCX to fix mid-LCX stenosis 1 case with diffuse, calcified mid-RCA stenosis, during attempted direct stenting EXCELN=607 CYPHERN=178 TAXUSN=111 BMSN=49 BIOMATRIXN=41ENDEAVOURN=7Demographics & CV Risk Factors N patients357 Age (yrs)58.8 + 9.7 Male / female297/60 Family history108 (30.2%) H

11、ypertension192 (53.8%) Dyslipidemia212 (59.4%) Diabetes mellitus126 (35.3%) Smoking162 (45.4%) Prior MI163 (45.7%) Prior CABG19 (5.3%) Prior PCI101 (28.3%) Clinical Presentation No. patients357 No. lesions812 No. stents993 Clinical presentation Stable angina153 (42.8%) Unstable angina / ACS42 (11.8%

12、) Acute MI17(4.8%) Recent MI ( 50%)In-segment7/52 (13.5%)3/42 (7.1%)9/186 (4.8%)2/19 (10.5%)In-stent6/52 (11.5%)2/42 (4.8%)7/186 (3.8%)2/19 (10.5%)CYPHERTAXUSEXCELBMSQCA analysis at 6 months* * Biomatrix = 3 & Endeavour = 1 were not included in the analysisCumulative Distribution Curves for EXCEL St

13、ent Cumulative Distribution Curves for All Stents CYPHEREXCELTAXUSBMSConclusion1.Despite the inclusion of challenging “real world cases” (DM, 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