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 Polymer (Degradable) for Drug-Excel Sirolimus JW Medical -BioMatrix Biolimus A9 Biosensors- Infinnium Paclitaxel/Sirolimus SMT(印度 ) -Nobori Biolimus A9 Terumo- Champion Everolimus Guidant Polymer (Degradable) Plus Holes for Drug- CoStar Paclitaxel Conor / Biotronik（ Cordis） No Polymer But Holes for Drug- Janus Tacrolimus Sorin - Taxcor Paclitaxel Eurocor(Germany) No Polymer But Special Stent Surface for Drug- Axxion Paclitaxel Biosensors -Yukon Sirolimus Translumina(Germany) - ALA Abciximab Korean AMP-Yinyi Paclitaxel Yinyi Polymer (Nondegradable) for Drug (Conventional DES) - Cypher Select Sirolimus Cordis / Johnson & Johnson - Taxus Libert Paclitaxel Boston Scientific - Endeavor Zotarolimus Medtronic -Xience Everolimus Abbott / Guidant -Firebird Sirolimus Microport -Partner Sirolimus Lepu Active (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 w 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 w June 2008 TCTMD 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），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 （ N 202） 永久性聚合物 （ N 202） 无聚合物 （ N 201） 晚期管腔 丢 (6-8月 ) 0.170.45mm 0.230.46mm 0.470.56mm TLR（ 1年） 12例 16例 26例 明确的血栓 0 1 2 很可能的血栓 1 0 0 可能的血栓 1 3 1 总计 2 4 3 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。 生物可降解聚合物支架 wBioMatrix（ Biosensors） wNobori（ Terumo） wExcel（ JW Medical） wInfinnium (SMT) BEACON Registry (PI: TH Koh) De Novo /Restenotic Native Coronary Artery Lesions Multi-lesion / Multi-vessel Vessel Diameters: 2.5 4.0 mm Stent Diameters: 2.5 4.0 mm Lesion Length: 10 mm 28 mm Stent Lengths: 8 - 28 mm 8 and 12 mm Lengths for Bailout Only Pre-Dilatation perferred 30 d 6 mo 9 mo 12 mo Clinical Follow-Up Primary Endpoint: TVR at 6 months Key Secondary Endpoints: MACE at 30 days, 6 months, 12 months Clinically driven TLR, TVR at 9 & 12 mos Device, Lesion and Procedure Success Anti-Platelet Therapy at Investigators Discretion BioMatrix I N = 292 Evaluable 10 Sites in Asia Prospective, Multi-Center, Electronic Registry(2007) BEACON Registry Patient Characteristics BioMatrix I 292 Patients Age 57 (26-83) Diabetes (%) 38 Hypertension (%) 68 Hypercholesterolemia (%) 67 Smoking history (%) 42 Family history of CAD (%) 25 Prior MI (%) 41 Previous PCI (%) 19 Previous CABG (%) 2 Unstable Angina (%) 29 LVEF (%) 56 BEACON Registry Target Lesion Characteristics ACC/AHA Lesion Classification Lesion Localization Bifurcation lesions Moderate/Severe calcification Lesions 24mm Small vessel 2.5mm CTO* De novo lesions Restenotic lesions Count 56 22 51 137 22 387 6 14.2 5.6 13.0 34.9 5.6 98.5 1.5 % * CTO and any other 100% occluded lesions were not recommended as target lesion (as per protocol - treatment strategy). n = 393 Target Lesions BEACON Registry Lesion Characteristics BEACON Registry Lesion Characteristics BioMatrix I 393 Lesions Lesion length (mm) 16.2 Vessel size (mm) 2.89 Diameter stenosis (%) 82 Stent length (mm) 21 Stents per lesion 1.1 Stents per patient 1.4 Device Success (%) 99.7 Lesion Success (%) 98.8 Procedure Success (%) 95.9 BEACON Registry Clinical Events % MACE at 30 Days 2 patients (0.7%) with early stent thrombosis day 5 and day 6 Study Primary Endpoint* - 180 Day TVR 0 - 30 Day 31 - 180 Day 181 360 Day 180 Days 360 Days TVR Rates CABG PTCA 3 (1.0%) 0 (0.0%) 3 (1.0%) 3 (1.0%)* 0 (0.0%) 3 (1.0%) 2 (0.7%) 0 (0.0%) 2 (0.7%) 6 (2.1%)* 0 (0.0%) 6 (2.1%) 8 (2.8%) 0 (0.0%) 8 (2.8%) * One patient had two TVRs. Cumulative BEACON Registry Clinical Events BEACON Registry Clinical Events % MACE at 12 Months No stent thrombosis between 30 days and 12 months 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 problem), use BMS Antiplatelet regimen: ASA 160 mg indefinitely (unless contraindicated) 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 angulated LCX to fix mid-LCX stenosis 1 case with diffuse, calcified mid-RCA stenosis, during attempted direct stenting EXCEL N=607 CYPHER N=178 TAXUS N=111 BMS N=49 BIOMATRIX N=41 ENDEAVOUR N=7 Demographics & CV Risk Factors N patients 357 Age (yrs) 58.8 + 9.7 Male / female 297/60 Family history 108 (30.2%) Hypertension 192 (53.8%) Dyslipidemia 212 (59.4%) Diabetes mellitus 126 (35.3%) Smoking 162 (45.4%) Prior MI 163 (45.7%) Prior CABG 19 (5.3%) Prior PCI 101 (28.3%) Clinical Presentation No. patients 357 No. lesions 812 No. stents 993 Clinical presentation Stable angina 153 (42.8%) Unstable angina / ACS 42 (11.8%) Acute MI 17(4.8%) Recent MI ( 50%) In-segment 7/52 (13.5%) 3/42 (7.1%) 9/186 (4.8%) 2/19 (10.5%) In-stent 6/52 (11.5%) 2/42 (4.8%) 7/186 (3.8%) 2/19 (10.5%) CYPHER TAXUS EXCEL BMS QCA analysis at 6 months* * Biomatrix = 3 & Endeavour = 1 were not included in the analysis Cumulative Distribution Curves for EXCEL Stent Cumulative Distribution Curves for All Stents CYPHER EXCEL TAXUS BMS Conclusion 1.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 res