藥物支架的臨床結(jié)果及藥物支架時(shí)代的CABG(2013年嶺南會(huì))課件

藥物支架的臨床結(jié)果

及藥物支架時(shí)代的CABGFinalResultsfromtheACCF-STSDatabaseCollaborationontheComparativeEffectivenessofRevascularizationStrategies(ASCERT)WilliamSWeintraub,etal.ACC2012PurposeTocomparelong-termmortalityofcoronaryarterybypasssurgeryandpercutaneouscoronaryinterventionConclusionsSurvivalwassimilarinthetwoarmsat1yearsSurvivalwashigherintheCABGthanPCIarmat4yearsTheresultswerelargelyconsistentacrosssubgroupsThisislargelyconsistentwithbothclinicaltrialandobservationalstudiesSirolimusElutingStentwithBiodegradablePolymerversusSirolimusElutingStentwithDurablePolymerfortheTreatmentofPatientswithdenovoCoronaryArteryLesions(EVOLUTION):ARandomizedNon-inferiorityTrial(Oneyearresult)JunboGe,etal.ACC2012Thisstudysoughttoinvestigatethesafetyandefficacyofsirolimuselutingstent(SES)withbiodegradablepolymerascomparedwithSESwithdurablepolymerin5yearsfollowup.AimofthepresentstudyEVOLUTIONWeundertookamulticenter,open-label,non-inferiorityrandomizedstudyin30centersinChinafromDecember2008toSeptember2010.Atotalof1923patientswithdenovocoronaryarterylesionswererandomizedtoimplantwitheitherSESwithbiodegradablepolymer(EXCEL,JWMedicalSystemLtd,Weihai,China)(n=1239)orSESwithdurablepolymerstent(CypherSelect,CordisCorporation,MiamiLakes,Florida,USA)(n=670).MethodsEVOLUTIONPrimaryEndpoint:TVFthrough12MonthsNon-InferiorityTest

RateDifference(EXCEL-CYPHER)Lower95%CIofRateDifference(EXCEL-CYPHER)Upper95%CIofRateDifference(EXCEL-CYPHER)PvalueTVF-0.45%-1.41%0.50%<0.05Note:Non-InferiorityMargin=4%,

Lower95%CIofRateDifference=-1.41%,so-1.41%>-4%,non-inferioritytestP<0.05,EXCELisnotinferiortoCYPHER.EVOLUTIONConclusionsAt1-yearfollowup,thesirolimuselutingstent(SES)withbiodegradablepolymeriscomparabletoSESwithdurablepolymerintermsofclinicalefficacyandsafety.Longertermfollow-up,especiallyafterstoppingantiplatelettherapy,willbenecessarytofindoutthepotentialdivergenceinoutcomesbetweenthetwodifferenttypeofstents.EVOLUTION2YearClinicalOutcomesfromthePivotalRESOLUTEUSStudyLauraMauriMD,MSconbehalfoftheRESOLUTEUSInvestigatorsBrighamandWomen’sHospitalBoston,MAACC2012HxControlsPerformanceGoalsResolutestent2.25–3.5Clinical(n=1242)2.25–3.5Angio/IVUS(n=100)4.0Angio(n=60)38mmClinical(n=110–175)RESOLUTEUSPI:M.Leon,L.Mauri,A.YeungPrimaryEndpoints:2.25–3.5Clinical→TargetLesionFailureat12mo2.25–3.5Angio/IVUS→In-StentLLLat8mo4.0Angio→In-SegmentLLLat8mo38mmClinical→TargetLesionFailureat12moDrugTherapy:ASAandclopidogrel/ticlopidine≥6mo(perguidelines)DeNovoNativeCoronaryLesionVesselDiameter:2.25–4.2mmLesionLength:≤27mm(≤35mm

lesionstxw/38mmstent)ClinicalendpointsAngio/IVUSendpoints6mo4yr3yr2yr12mo18mo8mo5yr9mo30dN=max1577patientsUpto135USsitesClinicalStudyDesignMauriL,etal.AmHeartJ.2011;161:807-14.RESOLUTEUSPatientFlowChart1YrClinicalFollow-upn=138698.9%PatientsEnrolledN=14022YrClinicalFollow-upn=135996.9%ACC2013

外科微創(chuàng)技術(shù)和概念也得到迅速發(fā)展，使得手術(shù)的創(chuàng)傷性越來(lái)越小，并發(fā)癥發(fā)生率越來(lái)越少，而且明顯縮短病人的恢復(fù)時(shí)間。不停跳非體外循環(huán)下CABG微創(chuàng)獲得血管材料鎮(zhèn)痛技術(shù)的發(fā)展藥物支架時(shí)代的CABG傷口感染率從常規(guī)切口的28.3％降到6.8％，減少了相關(guān)并發(fā)癥的發(fā)生；避免傳統(tǒng)移植靜脈獲取方法所造成的長(zhǎng)的切口創(chuàng)傷；減少術(shù)后殘留瘢痕；促進(jìn)早期下床活動(dòng)。內(nèi)窺鏡輔助獲取大隱靜脈減少了傳統(tǒng)胸骨正中切口的創(chuàng)傷；經(jīng)左前外、左胸骨旁、劍突下或右前外側(cè)切口；在常溫心臟不停跳下進(jìn)行CABG；大大縮短了患者的康復(fù)時(shí)間，降低了術(shù)后并發(fā)癥。小切口直視下的CABG將胸腔鏡技術(shù)應(yīng)用到心臟搭橋；進(jìn)一步減少了創(chuàng)傷；促進(jìn)了CABG向微創(chuàng)的方向發(fā)展。胸腔鏡輔助下的CABG在胸壁上開三個(gè)個(gè)窗，運(yùn)用機(jī)械手的遙控操作完成手術(shù)，將手術(shù)創(chuàng)傷減到最少。1998年5月，德國(guó)的Mohr運(yùn)用DaVinci系統(tǒng)完成了世界上首例機(jī)器人輔助下的CABG，該技術(shù)從此陸續(xù)在全球得到了推廣，手術(shù)和現(xiàn)代科技的結(jié)合大大縮短了患者的住院時(shí)間，減少了術(shù)后并發(fā)癥，更為患者所接受。運(yùn)用機(jī)器人輔助的CABG在跳動(dòng)的心臟上進(jìn)行手術(shù)操作，避免了體外循環(huán)引起的并發(fā)癥和心肌的再灌注損傷，減少手術(shù)創(chuàng)傷，加快康復(fù)時(shí)間，降低住院費(fèi)用。在各種微創(chuàng)切口和胸腔鏡的輔助下，OPCAB能做到病變心肌的完全血管化，不受病變血管數(shù)量和位置的限制，尤其適用于心室功能受損的患者。非體外循環(huán)下CABG

(off-pumpCABG,OPCABG)1993年華盛頓大學(xué)提出“快通道心臟麻醉”概念；就是要求術(shù)后即刻或術(shù)后1小時(shí)內(nèi)拔管氣管插管，以便病人盡早回到普通病房；而術(shù)后鎮(zhèn)痛的普遍采用，消除了疼痛給病人帶來(lái)的不便和痛苦，麻醉方法的改進(jìn)讓患者能盡早下床活動(dòng)，加快院內(nèi)的康復(fù)，減少心理負(fù)擔(dān)身體上的痛苦?？焱ǖ佬呐K麻醉

(fasttrackingcardiacanesthesia)ACC2013ACC2013首個(gè)高手術(shù)風(fēng)險(xiǎn)患者的體外循環(huán)和非體外循環(huán)下CABG的對(duì)比研究；206