信心来自循证PROMUSElement循证医学数据与病例分享.ppt

信心来自循证 PROMUS Element 循证医学数据与病例分享,曹丰 中国人民解放军总医院心血管内科,循证医学PLATINUM Trial 铂金试验 PROMUS Element支架 治疗de novo 病变,PLATINUM QCA 研究,循证医学PLATINUM Trial 铂金试验 PROMUS Element支架 治疗de novo 病变,PLATINUM QCA 研究,PLATINUM QCA Trial 同类研究一览,晚期管腔丢失 (mm),SPIRIT First,SPIRIT First,PLATINUM QCA,SPIRIT II,SPIRIT III,随访时间延长,N=23,N=237,N=301,N=73,N=20,6mths,6mths,8mths,9mths,12mths,EuroInterv 2010 (in press),PLATINUM QCA Trial (IVUS) 支架贴壁不良 (ISA),参照目标 (SPIRIT III: Xience V),术后即刻 ISA,晚期获得性ISA,晚期ISA,支架贴壁不良 (ISA) (%),p0.001,EuroInterv 2010 (in press),30 天,12 个月,PLATINUM QCA Trial 临床结果 (N=100),* Ischemia-driven TLR, or MI/cardiac death related to the target vessel (All events occurred in the same patient),EuroInterv 2010 (in press),循证医学PLATINUM Trial 铂金试验 PROMUS Element支架 治疗de novo 病变,PLATINUM QCA 研究,依维莫司洗脱冠状动脉药物支架,试验组：PROMUS Element,PBMA=poly (nbutyl methacrylate) (基底层); PVDF-HFP=poly (vinylidene fluoridecohexafluoropropylene) (一种生物相容性非常好的氟化共聚物载药层),依维莫司药物浓度: 1 ug/mm2 聚合物涂层: PBMA & PVDFHFP (厚度7m，不可降解),对照组：XIENCE V,316L 不锈钢,TAXUS, Cypher,MP35N 钴镍合金,L605 钴铬合金 EES,Endeavor, Resolute,PtCr 铂铬合金 EES,3%,钼,CoCr EES ( Xience V ) N=762,PtCr EES ( PROMUS Element ) N=768,1530 Patients with 1 or 2 de novo native coronary artery target lesions,RVD 2.5 to 4.25; Lesion length 24 mm,Peri-proc: ASA 300 mg, clopidogrel 300 mg load unless on chronic Rx,Randomized 1:1 Stratified by diabetes, intention to treat 1 vs. 2 target lesions, & study site,Clinical f/u only: 1, 6, 12, 18 months then yearly for 2-5 years,ASA indefinitely, thienopyridine 6 mos (12 mos if not high risk for bleeding),PLATINUM Workhorse 研究设计,PLATINUM Workhorse 研究终点,主要终点 12个月的靶病变失败 (TLF) - 靶血管相关的心因性死亡，或者 - 靶血管相关的心肌梗死，或者 - 缺血驱动的靶病变血运重建 符合研究方案的数据集* 次要终点 TLF包括的各因素 支架血栓 (ARC definite/probable) 技术成功 临床治疗操作成功,* Patients who received 1 assigned study stent Successful delivery & deployment of study stent to the target vessel, without balloon rupture or stent embolization Lesion DS30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital cardiac death, MI, or TVR,主要研究终点12个月的TLF,12个月的靶病变失败(TLF)非劣效性检验达标,UCB=upper confidence bound,3.5% 上 边 界 非 劣 效 性 界 限,0.001 0.60,0.0009 0.72,P值 (非劣效性检验) (优效性检验),Difference 2-sided 95% CI (1-sided UCB),Population,Per protocol (1 终点),Intent- to-treat 意向治疗,PROMUS Element PtCr-EES better,Xience V CoCr-EES better,From ACC 2011,靶病变失败 TLF,Months Since Index Procedure,CoCr-EES,PtCr-EES,No. at risk,铂金试验Workhorse研究 4年随访结果,Target Lesion Failure = cardiac death or MI related to the target vessel or ischemia-driven target lesion revascularization,Xience V CoCr-EES (N=749),PROMUS Element PtCr-EES (N=758),TLF Patients(%),8.5%,7.4%,HR 95% CI = 0.86 0.60, 1.24 P = 0.43,Primary Endpoint,ACC 2014 New！,缺血驱动的 TLR,Xience V CoCr-EES (N=749),PROMUS Element PtCr-EES (N=758),HR 95% CI = 0.76 0.48, 1.20 P = 0.24,Months Since Index Procedure,TVR Patients (%),CoCr-EES,PtCr-EES,No. at risk,5.9%,4.6%,铂金试验Workhorse研究 4年随访结果,ACC 2014 New！,3年的靶病变血运重建 (TLR) FDA 关键性试验结果一览,PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus PtCr EES Stent ) 1 PLATINUM 3-Year results presented by Ian T. Meredith, MD, ACC 2013; 2 SPIRIT III 3-Year results presented by Gregg W. Stone, MD at TCT 2009; 3 RESOLUTE US Study 3-Year results presented by Paul Teirstein, MD at ACC 2013. Results from different studies are not directly comparable. Information provided for educational purposes only.,SPIRIT III 2 3-Year,n=669,n=1,064,n=758,RESOLUTE US 3 3-Year,TLR (%),Promus Element 在FDA批准的药物支架 注册临床中拥有最低的TLR,Promus Element PtCr EES,Xience CoCr EES,Resolute CoNi ZES,PLATINUM Workhorse Trial 1 3-Year,0,3,6,9,12,0,2,6,4,10,8,0.4%,0.4%,安全性指标 支架内血栓,ARC Stent Thrombosis Definite/Probable (%)*,Months,CoCr-EES,PtCr-EES,No. at risk,Xience V CoCr-EES (N=762),PROMUS Element PtCr-EES (N=768),HR 95% CI = 0.99 0.20, 4.91 P = 0.99,铂金试验Workhorse研究 1年随访结果,* All were definite ST,From ACC 2011,次要终点 支架内血栓等 铂金试验Workhorse研究 4年随访结果,Event Rate (%),Cardiac Death,All Death,ARC ST (Def/Prob),MI,Q-wave MI,Time to event rates,ACC 2014 New！,循证医学PLATINUM Trial 铂金试验 PROMUS Element支架 治疗de novo 病变,PLATINUM QCA 研究,PLATINUM Small Vessel Trial1,3 Promus PtCr EES (n = 89) RVD = 2.04 mm Lesion Length = 14.15 mm,RESOLUTE US Trial2 Resolute CoNi ZES (n = 146) RVD = 2.15 mm Lesion Length = 12.40 mm,无 ARC 定义的支架血栓(def/prob) 无心肌梗死,1.4% 靶血管相关的心梗 1.4% ARC定义的支架血栓 (def/prob),Incidence Rate (%),Incidence Rate (%),PROMUS Element 铂金支架 小血管研究1 2年随访结果一览,PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus PtCr EES). PLATINUM Small Vessel Trial, Presented by Dominic Allocco MD, PCR 2012. Ian T. Meredith, AM, MBBS, PhD is the PI. There were no MIs in the PLATINUM Small Vessel Trial. Presented by Laura Mauri MD, MSc, ACC 2012. RESOLUTE US Trial studied the Resolute Stent. Results from different studies are not directly comparable. Information provided for educational purposes only. PROMUS Element Stent has a dedicated small vessel 2.25 mm stent model.,无 ARC 定义的支架血栓(def/prob) 无心肌梗死,PLATINUM Long Lesion Trial1 Promus PtCr EES (n = 100) RVD = 2.56 mm Lesion Length = 24.38 mm,PROMUS Element 铂金支架 长病变研究1 2年随访结果一览,Incidence Rate (%),Incidence Rate (%),PLATINUM Clinical Trial Program studied the PROMUS Element Stent (Promus PtCr EES). PLATINUM Long Lesion Trial, Presented by Teirstein, P, MD. TCT 2012. SPIRIT Prime Trial, Presented by Costa, M et al. TCT 2012. SPIRIT PRIME Trial studied the Xience Prime Stent. Results from different studies are not directly comparable. Information provided for educational purposes only. Deaths due to unknown causes were adjudicated as cardiac death.,SPIRIT PRIME Long Lesion Registry2 Xience CoCr EES (n = 104) RVD = 2.8 mm Lesion Length = 26.1 mm,4.8% 靶血管相关的心梗,主要终点：9个月的支架内管腔丢失 PROMUS Element PtCr EES 优于 TAXUS