1、Post BEST-CLI,BASIL 2 and REVIVEIs the controversy solved?Serdar Farhan,MD,FESC,FACC,FSCAIAssistant Professor of Medicine the Donald and Barbara Zucker School of Medicine,Hofstra/NorthwellInterventional Cardiology,Endovascular and Structural Heart Interventions,Lenox Hill Hospital,New YorkDisclosure
2、s:NonePost BEST-CLI,BASIL 2 and REVIVE.Is the controversy solved?NOEVOLUTION of clinical trials in revascularizationRITA-1,1993ERACI I,1993GABI,1994EAST,1994CABRI,1995BARI,1996ARTS I,2001ERACI II,2001AWESOME,2001SOS,2002MASS II,2004SYNTAX,2009CARDia,2010PRECOMBAT,2011FREEDOM,2012VA CARDS,2013EXCEL,2
3、016NOBLE,2016Coronary Revascularization CABG vs.PCI20072005BAESIC,1996BASIC,2004BASIL-1,2005Scandinavian THRUPASS,2009McQuade et al.,JVS(ePTFE/nitinol stent-graft vs PTFE bypass),2010SUPERB(SUrgical vs PERcutaneous Bypass),2017FINN-PTX(DES vs prosthetic above-Enzmann et al.,JACC-CI(Nitinol stent vs
4、autologous vein bypass),2019ZILVERPASS(ZILVER PTX DES vs above-knee prosthetic bypass),2017BEST-CLI,2022BASIL-2,2023PAD Revascularization:BSx vs.EVT5-year data5-year dataLager trialBSx vs EVT:4 studies to considerCLTIBASILBEST-CLIBASIL 2ICREVIVEBEST-CLIN Engl J Med 2022;387:2305-2316BEST-CLI subgrou
5、p analysisBASIL-2 Primary and secondary outcomeLancet 2023;401:1798809Direct comparison between BEST-CLI and BASIL 2FeatureBEST-CLI(NEJM 2022)BASIL-2(Lancet 2023)FundingMajority NIH+minor industryNHS onlyPopulationRF 46,infrainguinal infrapoplitealRF 46,infrapoplitealEligibilityFit for both BSx&EVT;
6、life expectancy 2 yrsFit for both BSx&EVT;life expectancy 6 moDesignCohort 1:BSx-GSV vs EVT(n=1395)Cohort 2:BSx-prosthetic vs EVT(n=385)BSx-GSV(n=172)vs EVT(n=173)Enrollment yield9%of screened10%of screenedPrimary endpointMALE(death,major amp,major reintervention)AFS(major amp or death)Median follow