JOVIN Banff DAWN February2106.pptx.pdf
Transcript of JOVIN Banff DAWN February2106.pptx.pdf
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THE DAWN TRIAL AND THE STATUS OF ENDOVASCULAR TREATMENT FOR ACUTE STROKE
BEYOND 6 HOURS
Tudor G. Jovin, M.D.
Associate Professor of Neurology and NeurosurgeryDirector, UPMC Stroke Institute
Director UPMC Center for Neuroendovascular TherapyUniversity of Pittsburgh Medical Center
SHOULDTHEREBEATIMEWINDOWFORACUTESTROKEINTERVENTIONS???
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DISCLOSURES
Consultant/AdvisoryBoard:OwnershipInterest:SilkRoadMedical–modest
Consultant/AdvisoryBoard:Covidien/Medtronic:unpaid
Consultant:StrykerNeurovascularunpaid
PI:REVASCAT(FundacioIctusMalalGaVascular),unpaid
PI:DAWN(StrykerNeurovascular),unpaid
Consultant:CodmanNeurovascular(DSMBmember–modest)
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Infarct volume (both treatment groups) strongly correlates with clinical outcome
(p<0.0001) P<0.0001
SWIFTPRIME,AlbersG.,etal,Stroke2015 IMS3,JovinT.,etal,ISC2015
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DarbyDGetal.Stroke.1999;30(10):2043
0 6 12 18 24
%
Time(hr)A=erStrokeOnset
PenumbralCore
00
25
50
75
100
Ischemic Penumbra
CORE
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SERIALMRI’S(CORONALSECTIONS)ATTHREELEVELSINTHEBRAINDEPICTINGTHEAPPARENTDIFFUSIONCOEFFICIENTOFWATER(ADC)(MARKEDBYTHEBLUECOLOUR)DEMONSTRATINGTHETIME-DEPENDENTGROWTHOFTHEISCHEMICCORE.
PROGRESSIVE GROWTH OF CORE IN MCA OCCLUSION
Hossmanetal.,CellMolNeurobiol,2006
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DEFUSE2
-20
30
80
130
180
230
0 2 4 6 8 10 12
Baselin
eDW
IVolum
e(m
l)
TimebetweenSymptomOnsetandBaselineMRI(hrs)
Initial Growth Rate: Known Onset & M1 Occlusion
WheelerHM,etal.IntJStroke.2015
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DEFUSE2
-20
30
80
130
180
230
0 2 4 6 8 10 12
Baselin
eDW
IVolum
e(m
l)
TimebetweenSymptomOnsetandBaselineMRI(hrs)
Initial Growth Rate: Known Onset & M1 Occlusion
WheelerHM,etal.IntJStroke.2015
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COLLATERALS
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Baseline MRI DEFUSE protocol
65YEAROLDMANPRESENTSWITHNIHSSOF15,9HOURSPOSTSX’SONSET.CTA-LICAOCCLUSION
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Khatri,LancetNeurology,2014
INTHEEARLYTIMEWINDOWIT’SALLABOUTTHETIMETOREPERFUSION
Every30minutedelayinreperfusionisassociatedwitha10%rela<vereduc<oninprobabilityof
goodclinicaloutcome(mRS0-2).
N=183MedianASPECTS:8
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Every30minutedelayinreperfusionisassociatedwitha5%rela<vereduc<oninprobabilityofgoodclinicaloutcome(mRS0-2).
Fransenetal.,JAMANeurol2016
RELATIONSHIPBETWEENTIMEFROMONSETTOREPERFUSIONANDGOODOUTCOMESINMRCLEAN
N=115MedianASPECTS=9
KHATRICURVEREVISITED
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RELATIONSHIPBETWEENONSETTOREPERFUSIONANDLIKELIHOODOFGOODOUTCOMEINESCAPE
CourtesyofDr.BMenon
N=113MedianASPECTS=9
Every30minutedelayinreperfusionisassociatedwitha0.5%rela<vereduc<oninprobabilityof
goodclinicaloutcome(mRS0-2).
KHATRICURVEREVISITED
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RELATIONSHIP BETWEEN TIME FROM ONSET TO REPERFUSION AND GOOD OUTCOMES IN REVASCAT
ProbabilityofmRS0-2-5%every30’ N=67
MedianASPECTS:7
RiboM,etal.,ESOC2015
Every30minutedelayinreperfusionisassociatedwitha5%rela<vereduc<oninprobabilityofgoodclinicaloutcome(mRS0-2).
KHATRICURVEREVISITED
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Only OR values with 95% CI < 1 are shown
-26% for each 30´ -28% for each 30´
-44% for each 30´ -50% for each 30´
LIKELIHOOD OF GOOD OUTCOME ACCORDING TO TIME INTERVALS FROM SX’S ONSET TO REPERFUSION AND
ASPECTS
Ribo et. al., Stroke, in press
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RELATIONSHIP BETWEEN TIME FROM ONSET TO REPERFUSION AND GOOD OUTCOMES IN DEFUSE 2
N=46Medianbaselineinfarctvolume=16cc
LansbergM.etal.,Neurology2015
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DEFUSE 2: Response to reperfusion is not time-dependent
in patients with salvageable tissue (mismatch)
16 LansbergandCereda,etal.Neurology;Aug2015
Treatment<6hoursTreatment>6hours
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WAKEUPSTROKEVSWITTNESEDONSETBEYOND8HRS-ISTHEREADIFFERFENCEINOUTCOMESWITHIAT?
AghaebrahimA.etal.,JNIS2015
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SHOULD WE TREAT PATIENTS WITH LVO AND MISMATCH BEYOND 6 HOURS WITH NO TIME LIMIT ???
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88 year old woman with L M1 occlusion, TLSW 22 hours, NIHSS 21, no intervenVon mRS at 3 weeks: 3
BaselineMRI/MRA–NIHSS21
4dayMRI/MRA–NIHSS11
MCAocclusion
MCAparGallyrecanalized
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88 year old woman with R M1 occlusion, TLSW 20 hours, NIHSS 17, no intervenVon mRS at 30 days 1
BaselineMRI/MRA
Follow-upMRI/MRAat24hours(NIHSS17)–noinfarctgrowthandparGalrecanalizaGon
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61 year old man with R M1 occlusion, TLSW 14 hours, NIHSS 21, no intervenVon 3 months mRS 4
BaselineMRI/MRA/CTP
MRI/MRAat24hours,NIHSS20
MRIatday5,NIHSS18
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OverviewTitle DWIorCTPAssessmentwithClinicalMismatchintheTriageof
WakeUpandLatePresenGngStrokesUndergoingNeurointervenGon(DAWN)
Sponsor StrykerNeyrovascularInc.
PIs TudorG.Jovin,MDandRaulG.Nogueira,MD
Funding StrykerNeurovascularInc.
Studydevice Trevo®ProVue™andTrevo®XPProVue™Retrievers
ControlintervenGon(IV-tPAyes/no?)
Bestmedicaltherapyincludingivt-PAineligiblepaGents(whichwillbeesGmatedtomakeupmaximium20%oftotal)
StudypopulaGon AcutestrokepaGentswithnoupperagelimitpresenGnginthe6-24hourGmewindowwithproximalanteriorcirculaGonocclusions(M1,ICAT)andsubstanGalclinical/coremismatch
ObjecGve ToevaluatethehypothesisthatTrevothrombectomyplusmedicalmanagementleadstosuperiorclinicaloutcomesat90daysascomparedtomedicalmanagementaloneinappropriatelyselectedsubjectsexperiencinganacuteischemicstrokewhentreatmentisiniGatedwithin6-24hoursamerlastseenwell.
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DAWN Trial: Why Do We Need to Do It?
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“PaGentseligibleforintravenousrtPAshouldreceiveintravenousrtPAevenifintra-arterialtreatmentsarebeingconsidered.”
ClassI LevelofEvidenceA UnchangedGuideline
EndovascularProtocolandPa`entSelec`on
PaGentsshouldreceiveendovasculartherapywithastentretrieveriftheymeetallthefollowingcriteria
a) prestrokemRSscore0to1,b) acuteischemicstrokereceivingintravenousr-tPAwithin4.5hoursofonset
accordingtoguidelinesfromprofessionalmedicalsocieGes,c) causaGveocclusionoftheinternalcaroGdarteryorproximalMCA(M1),d) age≥18years,e) NIHSSscoreof≥6,f) ASPECTSof≥6,andg) treatmentcanbeiniGated(groinpuncture)within6hoursofsymptomonset
NewRecommenda`onClassI LevelofEvidenceA
WilliamJ.Powers,ColinP.Derdeyn,JoséBiller,ChristopherS.Coffey,BrianL.Hoh,EdwardC.Jauch,KarenC.Johnston,S.ClaiborneJohnston,AlexanderA.Khalessi,ChelseaS.Kidwell,JamesF.Meschia,BruceOvbiagele,andDileepR.Yavagal.“2015AHA/ASAFocusedUpdateofthe2013GuidelinesfortheEarlyManagementofPaGentsWithAcuteIschemicStrokeRegardingEndovascularTreatment:AGuidelineforHealthcareProfessionalsFromtheAmericanHeartAssociaGon/AmericanStrokeAssociaGon.”AmericanHeartAssociaGonStrokeCouncil.StrokePublishedonlineJune29th2015.
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Raul Nogueira, MD
ForEvery10RandomizedPaGents
NNT=5
1:1RandomizaGon
5EndovascularArm 5ControlArm
DAWN
OpenRx
AssumingtheDAWNTreatmentParadigmisbeneficialandhasaverystrong
treatmenteffect(NNT=5)wewouldbemissingtheopportunitytohelponly1forevery10paGentsinthetrial
WhatistheWorstPriceWeCouldPay?
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Counterpoints Supporting Equipoise: Why DAWN Can Fail?
Longer Time from Stroke Onset to Treatment = ? Increased Risk of Hemorrhagic Transformation Longer Time from Stroke Onset to Treatment = ? Worse Reperfusion Rates Longer Time from Stroke Onset to Treatment = Better Collaterals = ? Better Natural History RCTs of Delayed IV Thrombolysis (including Mismatch-Based) Have Failed to Show a Benefit
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DAWN™ Trial
PrimaryObjecGveDWIorCTPAssessmentwithClinicalMismatchintheTriageofWake-UpandLatePresenGngStrokesUndergoingNeurointervenGon
ToevaluatethehypothesisthatTrevothrombectomyplusmedicalmanagementleadstosuperiorclinicaloutcomesat90daysascomparedwithmedicalmanagementaloneinappropriatelyselectedsubjectsexperiencinganacuteischemicstrokewhentreatmentisiniGatedwithin6-24hrsamerlastseenwell.
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Trevo® Retriever Thrombectomy Procedure
PhotographsandillustraGonsprovidedbyStrykerNeurovascular.
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• ProspecGve,randomized(1:1),mulG-center,PhaseII/III(feasibility/pivotal),adapGve,populaGonenrichment,blindedendpoint,controlledtrial
• Upto50sites(worldwide)• 150subjects(feasibility)upto500(pivotal)max• Primaryendpoint:
• DifferencebetweentheaverageweightedmRSat90daysbetweentreatmentandcontrolgroups
DAWN™ Trial Design
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DAWN™ Trial Unique Design Elements
PrimaryEndpoint:WeightedmRS
• DesignedtocapturehealthstatetransiGonsacrosstheenGrespectrum• EndpointthatisacombinaGonofbothefficacyandsafety• DifferenGatesoutcomes• PaGent-centeredoutcomesanalysis
Enrichment
• DesignedtofinetunethepaGentpopulaGonbasedoncoreinfarctsize• IdenGfysubgroupsexperiencingclinicalbenefit
mRS 0 1 2 3 4 5 6
Weight 10 9.1 7.6 6.5 3.3 0 0
Designedtomeasure
effecGveness&safetyinsingle
endpoint
0-50ccà0-45ccà0-40ccà0-35ccà0-30cc
hwp://dawntrial.trainingcampus.net
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UTILITY WEIGHTED MRS VS OTHER MODALITIES
Chasnainunkul,Saveretal.,Stroke2015
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DAWN™ Trial Unique Design Elements
ClinicalImagingMismatch
• Standardizesclinicalimagingtoselectsubjects
• LiteraturesupportscoreinfarctsizebeingpredicGveofoutcomes
• NIHSSassessment(clinicaldeficit)representsGssueatriskinrealGme,canbeeasilyadministered(andrepeated)mulGpleGmes,andisvalidatedinclinicalpracGce
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CLINICAL EXAM (NIHSS): A GOOD ESTIMATION OF THE AT RISK TERRITORY ??
Davalosetal.,Neurology2004
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DAWN™ Clinical Trial
RandomizaGonBalancedre:CIMsubgroup,GmeandocclusionlocaGon
StandardizedRAPIDsomware
ProximalOcclusion:
ICA-Tand/orMCA-M1Occlusion
ClinicalMismatch:
NIHSS>10
+SmallInfarct
Goal: To idenVfy the Target Mismatch PaVent in the 6-24h Window (including Wake-Up Strokes)
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ClinicalImagingMismatch(CIM)definedasoneofthefollowingonRAPIDMR-DWIorCTP-rCBFmaps:
a. 0-20cccoreinfarct&NIHSS≥10(&≥80yrsold)b. 0-30cccoreinfarct&NIHSS≥10(&<80yrsold)c. 31to≤50cccoreinfarct&NIHSS≥20(&<80yrsold)
WriwenConsentfromsubjectorLAR(ifnotobtainedpriortoRAPID)
Age≥18NIHSS≥10
Pre-strokemRS0-1<1/3MCAterritoryinvolved,asevidencedbyCTorMRI
OcclusionoftheintracranialICAand/orMCA-M1,byMRAorCTASubjectcanberandomizedwithin6-24hfromTLSW
DAWN Flow Chart – Screening and Enrollment
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RAPIDSo=warestandardizesmeasurementofcoreinfarctsize• SupportsobjecGvityinarandomizedclinicaltrial• Especiallyimportantfor6+hourpaGentpopulaGonwithunknowntreatmenteffect
• ONLYtheRAPIDcoreinfarctsizemaybeusedtodetermineeligibilityandstraGficaGon
• MRI-DWIorCTP-rCBF• 510(k)clearedhoweverDAWNTrialversioncanONLYbeusedforstudysubjectevaluaGon
• BaselineNIHSSmustbeobtainedwithin1houroftheRAPIDprocessedimagesusedforqualificaGon
DAWN™ Trial uses RAPID Socware
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Safety Outcomes
• Incidenceofstroke-relatedmortalityat90days• IncidenceofsICH,byECASSIIIdefiniGon,within24(-6/+24)hrspostrandomizaGon(Gmezero)
• IncidenceofneurologicaldeterioraGonfrombaselineNIHSSscorethroughDay5-7/Discharge(whicheverisearlier)postrandomizaGon(Gmezero).NeurologicaldeterioraGonisdefinedas≥4pointincreaseintheNIHSSscorefromthebaselinescore.
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Copyright © 2016 Stryker Confidential NV00018223.AA | Page 40 of 64
Site Status Maximum Number of Sites 31 Contracts Executed 21 Sites Qualified 31 Initiation Training Complete 26 IRB/EC Approvals 28 Subjects Enrolled 74
DAWN Trial Update (as of 18-Feb-2016)
Actual / Projected Enrollment
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Enrollment by Authorized Site (as of 18-Feb-2016)
0
0
0
0
0
0
0
1
1
1
2
2
2
4
5
6
7
17
26
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Baptist Jacksonville (Dr. Hanel, ATE 01/21/16)
Christiana (Dr. Satti, ATE 01/21/16)
Kaiser LA (Dr. Feng, ATE 11/19/15)
Royal Melbourne (Dr. Mitchell, ATE 11/12/15)
KUMC (Dr. Abraham, ATE 02/01/16)
Florida Hospital (Dr. Hellinger, ATE 11/09/15)
Rush (Dr. Chen, ATE 05/07/15)
Buffalo (Dr. Levy, ATE 12/01/15)
CPMC (Dr. English, ATE 05/05/15)
Capital (Dr. Vez, ATE 07/01/14)
Erlanger (Dr. Devlin, ATE 06/05/15)
Hopital Purpan Toulouse (Dr. Cognard, ATE 01/28/16)
Abington (Dr. Shah, ATE 10/29/15)
Valley Baptist (Dr. Hassan, ATE 03/31/15)
UH Cleveland (Dr. Sila, ATE 05/04/15)
Riverside (Dr. Budzik, ATE 08/28/14)
Texas Stroke Institute (Dr. Bhuva, ATE 04/10/15)
Grady (Dr. Nogueira, ATE 11/25/14)
UPMC (Dr. Jadhav, ATE 10/31/14)
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DAWN Time Points
61
111
133
78
27
0
20
40
60
80
100
120
140
Door to
Imaging
Door to
Randomization
Door to
Puncture
Imaging to
Puncture
Randomization to
Puncture
DAWN Trial Median Time Points (Minutes)
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CURRENT ENROLLMENT STATUS
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• Stroke/Interven`onalNeurology• TudorJovin,MD
• AshuJadhav,MDPhD
• LawrenceWechsler,MD
• MaximHammer,MD
• VivekReddy,MD
• MawStarr,MD
• ViktoriaTotoraiGs,MD
• NimaAghaebrahim,mD
• DanVictorGiurgiuGu,MD
• VascularEndovascularNeurosurgery• BrianJankowitz,MD
• AndrewDucruet,MD
• RobertFriedlander,MD
• PaulGardner,MD
• DanWecht,MD
• StrokeIns`tuteNursingStaff• LoriMassaro–CRNP
• SusanKim-CRNP
• MariaAbraham–PA
• ChrisGnaBonaccorsi–PA
• KathySeiler,RN
• CherieAdamsRN
• JonyaBrooks,RN
• KenCoval,RN
• Pa{Williams,RN
• Neurocri`calCare• BradMolyneaux,MD
• LoriShuwer,MD
• SherryChou,MD
• RuchiJha,MD
• KeesPolderman,MD
• Neuroanesthesia• ColeenMoran,MD
• FrankGyulai,MD
• TheresaGelzinis,MD
• EmergencyMedicine• CharissaPacella,MD
• FrankGuyewe,MD
• ChrisGill-MarGn,MD
• CliffCallaway,MD
• DonYealy,MD
• MikeTurturro,MD
• MariaGuyewe,MD
• Neuroradiology• BillDelfyew,MD
• CharBranstewer,MD
• EmanuelKanal,MD
• StrokeIns`tuteResearchStaff• LisaBaxendell–Researchcoord
• CarlynnGraves–Researchcoord
• PatriciaPorter–Researchcoord
• KaraArmbruster–Researchcoord
• YvonneCannon–Researchcoord
• HollyKromer-DataManagement
• NeuroIRRadiologyTechs&NursingStaff• KiwyO’Toole,RTVI
• CaseyFoster,RTVI
• JenniferHamil,RTVI
• JimBozak,RTVI
• JasonPaul,RTVI
• CandaceAcklin,RN
• JosieStashko,RN
• Neurorahabil`a`on• JenniferShen
• CaraCamiolo
• MikeBonimnger
• NeuroscienceNursing• MelanieSmith,RN
• BenMorrow,RN
• KateSpiering,RN
• ThereseDawson,RN
UPMCACUTEENDOVASCULARSTORKETEAM