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ImpressiveSafetyRecordContinuesinLongTermFollow-up81patientswith6-monthrenalCTA,MRAorduplexNovascularabnormalitiesatanysiteofRFdeliveryOneprogressionofapre-existingstenosisunrelatedtoRFtreatment(stentedwithoutfurthersequelae)Onenewmoderatestenosiswhichwasnothemodynamicallyrelevantandnottreated3deathswithinthefollow-upperiod;allunrelatedtothedeviceortherapyNohypotensiveeventsthatrequiredhospitalizationTherewerenoobservedchangesinmeanelectrolytesoreGFRExpandedresultspresentedattheAmericanCollegeofCardiologyAnnualMeeting2012(Krum,H.)PercentageRespondersIncreasesOverTimeResponderwasdefinedasanofficeSBPreduction≥10mmHg(n=143)(n=148)(n=144)(n=130)(n=107)(n=59)(n=24)(n=24)SymplicityHTN-2:RDNSuperiortoMedicalManagement,ReductionsSustainedto12M?fromBaselineto6Months(mmHg)PrimaryEndpoint:84%ofRDNpatientshad≥10mmHgreductioninSBP10%ofRDNpatientshadnoreductioninSBPSystolicDiastolicSystolicDiastolicRDN(n=49)?fromBaselineto12Months(mmHg)SystolicDiastolicPrimaryEndpoint(6MpostRandomisation)LatestFollow-up(12MpostRandomisation)LatestFollow-up:Controlcrossover(n=35):-24/-8mmHg(AnalysisonpatientswithSBP≥160mmHgat6M)p0.01for?frombaselinep0.01fordifferencebetweenRDNandControlMedicationChangesat6and12Months
Post-RenalDenervationRDN(n=47)6month12monthsDecrease(#MedsorDose)20.9%(9/43)27.9%(12/43)Increase(#MedsorDose)11.6%(5/43)18.6%(8/43)Crossover(n=35)6monthspost-RDNDecrease(#MedsorDose)18.2%(6/33)Increase(#MedsorDose)15.2%(5/33)PhysicianswereallowedtomakechangestomedicationsOncethe6monthprimaryendpointwasreached*SymplicityRDNSafetyRecordContinuestobeStronginExpandedResultsBaseline6month12monthseGFR(ml/min/1.73m2)76.9±19.3(n=49)77.1±18.8(n=49)78.2±17.4(n=45)CystatinC(mg/
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