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徐泽升

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”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.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2.5mmn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%）hyperlipidemia12（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 inhibiter 2（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%）Inverted 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 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 balloon 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 （3.3%）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，RCA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 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, clinical 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% nTarget 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 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 AMInCannot 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 death、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%DiscussionnPartner 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%nMACE 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（CYPHER）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 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.MajpjMVcyzj21HLfrvy96dv02lPPfYgxUS7IYmZkyEmZ0kGeYZS3bpLCkYH1lt4EK7CxmUX3ijoYSOer7ZuaVWYgz4EpZrUirVpMzzvNtf1XZw5oswSXOtFaejnOcmfE1lZgnN1RSXg8wLCG8CVQ3XPJMvodPFWcpiYJgZazNSEPNIaklYSu7qSd1UpaxmZDlpN9zW7kljfsLCLi26Yv109ffbnDH8LbUN1G6ACURQ39eG12KHL9tXsZ1jzgoCK8g1kuNOh5eFvcmVT5ZYVQt9zk3rp3qLnf02FovEXxVRxjCcFRNppiJljNiOuk6fONnyX7fyGg7sXZ49BmCN5oy9VesHpKzdjTKwjrkCEQCFDehVmGax3lrOEbw63VscA3YSijtUKoCyiLzAlVRp7l4QgPNHxvJFFDyjUVN3oHlMah0XBd4uTbkfPIhHtw0evPmYOrdhEDoPwvYhzlGplU1AU9mpyiCXH8gpPCBRYjq77VcnbXumNE1yGfyTsbSj89J63kRTKDkKUg3mdS5sJ4X5cQ8dK7oW9IkScssECQdz2O9UTlpRjAFPChjhLdzopQzwxQf8ozdzOhogwAooXpUF83BX4C3jRgjDJiiXEUDMaNz4vQ4n164vspddHvOIVuBBdMA4xp1YhiHk0vOJ8TL1BxogzVlMpmod6ianYGmksQq6NWCEd56hZF4wfaNyZcrGfNxnPiG6ZAxSkfmhJAKtNmCqbRmppeXp8inz4eq3HkWCMSORyMMX522xpHG6basNr6KQfbZsFbHjzyNlJrruLolKFcC84dqfijBO5Dy2NaBcNEBPgQrT12PgpcKx2or2YChN5DPjs80zzdtdAdTKuW4uVv9bbZu3K2SZ2aEhTlIC1UqrIWibkzwHh6p8gLv26zr01mJybfOzFc4T7kQH1IpPwOzMDnAKPLsLrznXGjFNIA9bSWWms6ibKZwQIKrMzalwbFrQJvOP1rPH8rx2KkyYqrtQk5VRwM1HSX