avc criptogénico: estána alturade alteraras guidelines? · § ~25% of all ischemic strokes are...

AVCCriptogénico:Está na altura dealterar as

guidelines?

ClaudiaJorgeUniversityHospitalofSantaMaria

Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?

AVCCriptogénico:Está na altura dealterar asguidelines?


Cryptogenic strokeremainsamajorchallenge

§ PFO-relatedstrokes,i.e.duetoparadoxicalembolism,havebeenstronglyimplicatedasapossiblecause

1-Hartetal.LancetNeurology20142-Wolfetal.CerebrovascularDis2015

3-Lechatetal.NEJM19884-Kissela,etal,Neurology2012

§ ~25%ofallischemicstrokesare“cryptogenic”1

§ 34-46%ofischemicstrokesoccurbetween18-60years2

§ PFOpresentin40-50%ofcryptogenic strokepatients3

§ YoungandmiddleagedpatientshavecontinuedexposuretoPFO-relatedrecurrencerisk



Normal appearing atrial septum

Septum Secundum Septum

Primum

Agitated saline study demonstrating right to leftshunting through the PFO

Blood clot passing through the PFO becoming a paradoxical embolism



CLOSURETrial2012 PCTrial2013 RESPECTtrial2013



Multicenter, randomized, open-label

PFOpercutaneousclosure(C)(n=447)

5.5%PFOCvs 6.8%MT,p=0.37

86%effectivePFOclosure3.2%majorvascularcomplications

Medicaltherapy(MT)(n=462)

Recurrentstroke:2.9%closurevs 3.1%MT,riskdifference– 0.13%

PrimaryendpointstrokeorTIA(2years)deathfromanycause (first30days)deathfromneurologiccauses(31daysand2years)

AF:5.7%PFOCvs 0.7%MT,p<0.001

Starflex device(NMTMedical,Boston,MA)2yearsfollow-up


PrimaryendpointComposite ofdeathfromanycausenon-fatalstroke,TIAperipheralembolism




AF:2.9%PFOCvs 1.0%MT,p=0.16Bleeding:3.9%PFOCvs 5.7%MT,p=0.4

3.4%PFOCvs 5.2%MT

Recurrentstroke:0.5%closurevs 2.4%MT,p=0.14

AMPLATZERPFO(St.JudeMedical,Inc,St.Paul,MN)

4yearsfollowup





AF:3.0%PFOCvs 1.5%MT,p=0.13

Claudia Jorge, Hospital de Santa Maria

3/9 device group patients did not have adevice at timeof endpoint stroke

72.7% risk reduction of stroke in favor of device

Bleeding:1.6%PFOCvs 1.9%MT,p=0.8

Recurrentstroke1.8%PFOCvs3.3%TM,p=0.08

AMPLATZERPFO(St.JudeMedical,Inc,St.Paul,MN)

2.5yearsfollow-up


RESPECT protocol required follow-up until Food and Drug Administration (FDA)regulatory decision (data lock, August 2015)

FDA Advisory Panel in May 2016 requested a final analysis of long-termoutcomes using updated data (data lock, May 2016)

In the ITT population, early and medium-term results in in RESPECT showed pointestimates in favor of closure but did notreach statistical significance

Loweventratesincreaseimportanceoflonger follow-up



IntheRESPECTtrial,forpatientswithcryptogenicstrokeandPFO,closurewiththeAMPLATZERPFOOccluder isanappropriatetreatmentoptionthatreducestheriskof

recurrentstroke,with very low risk


RESPECTTRIALAugust 14,2015,

Primary events18PFOClosure vs 24MTevents

Dropout rate18.2%PFOClosure vs 30.1%MT

Atrial fibrillation4.2%PFOClosure vs 1.9%MT

DVTor pulmonary embolism18PFOClosure vs 3MT



GORE®HELEX®Septal Occluder /GORE®Septal Occluder + antiplatelet medical vsantiplatelet medicalmanagement alone

Population:PFOand cryptogenic stroke or imaging-confirmed TIA

https://clinicaltrials.gov/ct2/show/NCT00738894



Primary objective

assess whether chronic anticoagulation on the one hand and endovasculartreatment on the other hand are superior to chronic antiplatelet therapy

https://clinicaltrials.gov/ct2/show/NCT00562289?term=close+pfo&rank=2



“Forthosewhobelieve,noexplanationisnecessary;forthosewhodon't,noexplanationispossible.“JosephDunninger


AVCCriptogénico:

Está na altura devoltar a alterar asguidelines!

RecentpublicationsandresearchonCTO Claudia Jorge, Hospital de Santa Maria

Obrigada!

[email protected]

• Nunca em doentes assintom.ticos !• •Encerramento em alguns doentes comAVCcriptog.nico

• •Melhor selec..odosdoentes criptog.nico (estudocompleto doAVC)e

• identifica..odecaracter.sticas derisco• •Discuss.o benef.cio /risco individualizada• •Aguardar novos estudos eresultados defollow-upmais longo dosj.

• existentes• •Novos dispositivos (endotelizáveis /biodegrad.veis)

avc criptogénico: estána alturade alteraras guidelines? · § ~25% of all ischemic strokes are...

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