藥物支架的臨床結果

及藥物支架時代的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

外科微創技術和概念也得到迅速發展，使得手術的創傷性越來越小，并發癥發生率越來越少，而且明顯縮短病人的恢復時間。不停跳非體外循環下CABG微創獲得血管材料鎮痛技術的發展藥物支架時代的CABG傷口感染率從常規切口的28.3％降到6.8％，減少了相關并發癥的發生；避免傳統移植靜脈獲取方法所造成的長的切口創傷；減少術后殘留瘢痕；促進早期下床活動。內窺鏡輔助獲取大隱靜脈減少了傳統胸骨正中切口的創傷；經左前外、左胸骨旁、劍突下或右前外側切口；在常溫心臟不停跳下進行CABG；大大縮短了患者的康復時間，降低了術后并發癥。小切口直視下的CABG將胸腔鏡技術應用到心臟搭橋；進一步減少了創傷；促進了CABG向微創的方向發展。胸腔鏡輔助下的CABG在胸壁上開三個個窗，運用機械手的遙控操作完成手術，將手術創傷減到最少。1998年5月，德國的Mohr運用DaVinci系統完成了世界上首例機器人輔助下的CABG，該技術從此陸續在全球得到了推廣，手術和現代科技的結合大大縮短了患者的住院時間，減少了術后并發癥，更為患者所接受。運用機器人輔助的CABG在跳動的心臟上進行手術操作，避免了體外循環引起的并發癥和心肌的再灌注損傷，減少手術創傷，加快康復時間，降低住院費用。在各種微創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。非體外循環下CABG

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

(fasttrackingcardiacanesthesia)ACC2013ACC2013首個高手術風險患者的體外循環和非體外循環下CABG的對比研究；206