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1、应用Partner支架完成Crush技术治疗冠脉分叉病变的即刻及近 期随访结果沧州市中心医院 徐泽升 背景n2005年Partner支架上市n2008年全国21个心脏中心1352名患者的临床研究背景n糖尿病患者占23.3% n急性冠状动脉综合征的患者占90.49%nC型病变占30.98% n分叉病变占11.13% n慢性完全闭塞病变占7.81%背景n1年累积心源性死亡0.52% n心肌梗死0.96% n靶血管重建2.14% nMACE 3.62% n1年累积血栓发生率0.166% 背景n该研究208(11.13%)处分叉病变n分叉病变分型、术式、结果?目的n评价国产Partner支架在“真分叉
2、”病变应用Crush技术治疗的即可及近期近期疗效“真分叉”病变nA new classification of coronary bifurcation lesionsnMedina A, Surez de Lezo J, Pan M.nRev Esp Cardiol. 2006 Feb;59(2):183. Spanish. No abstract availableCrush技术nModified T-stenting technique with crushing for bifurcation lesions: immediate results and 30-day outcome.
3、nColombo A, Stankovic G, Orlic D, Corvaja N, Liistro F, Airoldi F, Chieffo A, Spanos V, Montorfano M, Di Mario C.nCatheter Cardiovasc Interv. 2003 Oct;60(2):145-51.入选标准n经桡A造影证实为冠状动脉真性分叉病变n主支&分支狭窄大于75%n主支血管直径大于2.75 mmn分支血管直径大于2.5 mm n均有心肌缺血的临床症状排除标准n急性心肌梗死primary PCI n不能接受抗血小板及强化抗凝治疗n主支、分支血管直径小于2.5mm
4、n主支血管直径大于5.0mm手术成功指标n支架置入即刻成功:指支架完全覆盖靶病变并充分扩张至残余狭窄 20%。n随访治疗成功:指随访时造影提示血流TIM I 3级且残余管腔狭窄小于30%随访n随访: 门诊随访或电话随访的方式,查询并记录主要终点事件的发生情况n主要终点:主要不良心脏事件(MACE,包括心源性死亡、非致死性心肌梗死和靶血管再次血运重建)发生率Baseline characteristicsvariablePatients(n=30)Age(yrs)61.711.2male20(66.7%)smoker16(53.3%)hypertention19(63.3%)hyperlipid
5、emia12(40.0%)Diabetes mellitus8(26.7%)Family history2(6.7%)Baseline characteristicsvariablePatients(n=30)Unstable angina pectoris 21(60%) Acute MI within 2 weeks 9(30%)Previous heart failure2(6.7%)Baseline characteristicsvariablePatients(n=30)Intraaortic balloon pumb0(0%)Glycoproteinb/a inhibiter2(6
6、.7%)IVUS guidence1(3.3%)CAG follow-up9(30%)Follow-up time(months)5.42.1Procedural findingsvariablePatients(n=30)transradia2(6.7%)transfemoral28(93.3%)6F guiding cathter2(6.7%)7F guiding cather27(90%)8F guiding cather1(3.3%)Type of crushvariableBifurcation=31Mini-crush23(74.2%)Step crush7(22.6%)Inver
7、ted crush1(3.2%)Procedural findingsvariablePatients(n=30)Number of bifurcation31(103.3%) LAD&LCX10(32.3%) LAD&Diag16(51.6%) LCX&Marg2(6.5%) RCA&PD3(9.7%)Procedural findingsNumber of bifurcationMain branch(n=31)Side branch(n=31)Number of stents1.50.551.1 0.34Mean stent length37.21.221.60.83Mean stent
8、 diameter 3.270.512.760.48Maximal inflation pressure(atm)15.40.6514.40.71Final kissing techniqueNumber of patient30number of bifurcation31Final kissing30(96.8%)Type of re-wire coating23(76.7%) no-coating7(23.3%)Anchor technique3(10%)Kissing pressure (atm) 8.670.89Final kissing techniqueType of ballo
9、on 1.252(6.7%) 1.522(73.3%) 2.06(20%)Kissing balloon N+N8(26.7%) N+C10(33.3%) C+C12(40%)In-hospital outcomesVariablePatients(n=30)Death0Periprocedural MI1(3.3%) Non-Q-wave1(3.3%) Q-wave0Stent thrombosis0Emergent revascularization0Follow-up resultsVariablePatients(n=30)Death0MI0TLR1(3.3%)TVR0MACE1 (3
10、.3%)讨论n即刻手术成功率达100%n5.42.1月MACE发生率分别为3.3%n心源性死亡0%n非致死性心肌梗死0%讨论nPartner西罗莫司洗脱支架是我国自主创新设计 的一种支架,支架平台采用双螺旋结构,使得整个支架系统具有较好的支撑力和贴壁性能。n在Partner西罗莫司洗脱支架,西罗莫司120g/ cm2装载在多PBMA /PEVA聚合物涂层上,外表再覆盖一层表面涂层( top coating)以控制药物释放速度。讨论n高压扩张15.40.65 atmn非顺应性球囊的应用58.1%nFinal kissing的完成96.8%Case-1n男性,79岁n3年前AMI,急诊PCI,RC
11、A置入支架2枚n6个月前不稳定心绞痛Case1(pre-PCI)Case1(post-PCI)LCX 2.7536 PartnerLM to LAD 3.524+3.036 ParterCase1(7 months follow up)Case-2 LCX os restenosisn2001年LAD支架(CYPHER)术后1年心绞痛再发n2009年4月LM Crush(Partner),术后4个心绞痛再发n2009年9月LCX os PTCA+RCA os Stentn脑梗死后遗症+糖尿病Case-22001,LAD,CypherCase-2LCX 2.524&2.529 PartnerLM
12、 to LAD 3.024 PartnerCase-2 (5 months follow up)Final kissing(3.015 & 2.515)Case-2Case-2RCA os 3.015 partner Case-3n男性 59岁n突发心前区疼痛7小时n高血压病史20年n糖尿病史11年First : CRUSHLAD2.7524&D2 2.512 PartnerSecond :CRUSHLM to LAD 3.524 Rumas 2.536 Partner BMW in LCX研究不足n样本量小n随访时间短n缺少双盲、对比研究结论n本临床研究初步证实,Partner支架在实际临床
13、中治疗真是安分叉病变安全、有效。n相对低的费用使国产西罗莫司洗脱支架Partner在国内的临床复杂病变更具有吸引力。Thanks for your attention!Partner stents for crush technique in coronary bifurcation: immediate and short-time follow-up resultsCang Zhou Central HosipitalXu Ze-shengBackgroundnIn 2005, Partner stents have been on the market.nIn 2008, clinica
14、l study involving 1352 patients in 21 cardiovascular centersBackgroundnDiabetes mellitus 23.3% nAcute coronary syndrome 90.49%nC-type lesion 30.98% nBifurcation lesion 11.13% nChronic total ccculusion 7.81%Backgroundn1 year accumulative cardiovascular mortality 0.52% nCoronary infarction 0.96% nTarg
15、et vessel reconstruction 2.14% nMACE 3.62% n1 year accumulative thrombosis rate 0.166% BackgroundnThe study include 208(11.13%) Bifurcation lesionsnTypes of bifurcation lesions, procedure method?ObjectivenTo observe the immediate and follow-up results of home-made Partner stents for crush technique
16、in true bifurcation lesions.Inclusion Criteria nTrue bifurcation lesions confirmed by transradial artery angiographynStenosis 75% in main artery & branch arteriesnMain artery diameter 2.75 mmnbranch arteries diameter over 2.5 mm nSymptoms of myocardial ischemiaExclusion CriterianPrimary PCI for AMIn
17、Cannot be treated with anti-platelet or intensive anticoagulant therapy nBranch arteries diameter 2.5mmnMain artery diameter 5.0mmMethodsnFollow up: outpatient follow-up or telephone follow-up, record main primary endpoint eventsnPrimary endpoint: main adverse coronary event (MACE:cardiovascular dea
18、th、non-fatal coronary infarction and target vessel revescularization ) ratesCriteria for successnimmediate success: stents completely covering target lesions and residual stenosis 20% after sufficient expansion。nfollow-up success: TIMI Grade 3 when follow-up and residual stenosis 30%DiscussionnPartn
19、er sirolimus-eluting stent is a new type domestic stent, DOUBLE-HELIX stent structure is engineered for outstanding flexibility and conformability.nSirolimus is loaded 120g/ cm2 in PBMA /PEVA compatible coating,and another top coating to control drug release.DiscussionnImmediate success rate 100%nMA
20、CE rate 3.3% in (5.42.1) monthsnCardiovascular mortality 0%nNon-fatal coronary infarction 0%DiscussionnExpand with high pressure to 15.40.65 atmnApplication of non-compliance balloon 58.1%nFinal kissing rate 96.8%Case-2 LCX os restenosisnIn 2001, angina recur 1 year after procedure with LAD stent(CY
21、PHER)nIn April, 2009, angina recur 4 months after procedure with LM Crush(Partner)nIn September, 2009, LCX os PTCA+RCA os StentnCerebral infarction sequelea plus DMCase-3nMale, 59 years oldnSudden chest pain for7 hours nHypertension for 20 yearsnDM for 11 yearsLimitationsnSmall scalenShort follow-up
22、 periodnCompare with foreign productsConclusionsnOur study preliminarily confirmed the safety and efficiency of Partner stents in clinical practice of treating true bifurcation lesions.nRelatively lower cost makes domestic sirolimus-eluting stent Partner attractive in clinical use of complex lesions.