facilitated pci vs rescue pci.pptx

8/16/2019 Facilitated PCI vs rescue PCI.pptx

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Facilitated PCI & rescue

PCIDolly mathew



• Primary PCI is the preferred reperfusionstrategy in STEMI

• Most patients donot arrive at the PCIcenter within the !mts of FMC

• If delay is e"pected# timely throm$olysis #followed $y early transfer for PCI

• Com$ined reperfusion strategies includefacilitated pci# pharmacoinvasivetherapy#rescue pci



Facilitated PCI

• Strategy of throm$olysis immediately followed $yPCI with a planned door to $alloon time !% '!mts in pts with STEMI

• (eduction in ischemia time# earlierreperfusion#higher TIMI III )ow in the occludedartery# with facilitation of guidewire or $alloonpassage# decreased clot $urden# lower incidenceof distal em$oli*ation

• Full + half dose throm$olysis # half dosethrom$olysis with ,PII$+IIIa antagonists

• -ddresses the value of pre treatment withthrom$olytics in patients otherwise eligi$le for



Pharmacoinvasive therapy

• ,iving T lysis at a non PCI center# transferthe pt to PCI center# performed within '%'. hrs within Tlytic therapy# regardless of

whether Tlysis results in successfulreperfusion

• Time to PCI is longer than facilitated PCI

• (outine early PCI after Tlysis in pts whoare not eligi$le for primary PCI



(escue PCI

• PCI performed urgently if Tlysis fails %Persistant hemodynamic or electrical

insta$ility

%Persistant ischemic symptoms %Failure to achieve /!%0!1 ST resolution

at !mts after infusion started



Timing of PCI



Trials reviewed % facilitated PCI



GRACIA 2002N50030 day results

Early post t lysisPCIVsRoutine drugtreatment

Early interventionsupr to drugtreatment

C-PIT-2 -MI '!!. 3 0!4! day results

Com$ined angioplasty5 pharmacologictreatment6sthrom$olysis

Primary end point sigreduced incom$ination group

FI3ESSE '!!.3 './'

! day results

Primary PCIFacilitated PCI witha$ci"ima$FPCI with reteplase ora$ci"ima$

3o signi7cantdi8erence in endpoints

-SSE3T% . PCI949+9'

Std PCI Tenecteplase 5 PCI

Prematurelyterminated

:(-6E3 '/4

;alf dose reteplase 5a$ci"ima$ + a$ci"ima$ alone 5 PCI

3o di8 in the post pci TIMI )owMa<or $leeding morein com$ination group



PCI immediately after throm$olysis%,(-CI- '!!' =,roup analysis of a+c I;D > lancet

• /!! -MI pts# '4 centers in Spain and Portugal# the 30-dayresults

% early interventional strategy within '. hours ofthrom$olysis # followed $y stent implantation

% post throm$olysis classical drug%$ased treatment

• Early intervention may $e superior to medical therapy in -MI• (eduction in inhospital ischemia driven revascularisation% '1vs '1 = p?o@oo >

• - com$ined therapy of stenting within '. hours of

throm$olysis results in shorter hospital stays and alower risA of adverse events after discharge#compared with conventional drug therapy



Com$ined angioplasty & pharmacological intrvention vs throm$olysis in -MI

% C-PIT-2 -MI B<acc'!!. trial

• 0! high%risA MI patients within hrs of symptomonset• throm$olysis alone with full%dose tenecteplase or

throm$olysis with full%dose tenecteplase followed $yimmediate transfer for C-, and possi$le PCI

=com$ination group>• Pts with failed throm$olysis also referred for C-,

&possi$le intervention

• The primary end point of the study was a composite ofdeath+MI+stroAe+recurrent ischemia at 4! days# whichwas signi7cantly reduced in the com$ination group

• Ma<or $leeding was not signi7cantly di8erent $etweenthe two groups



Ma or e!"a"y results in CAPI#A$%AMI End point Thrombolysis

aloneThrombolysisplus immediatetransfer forangiography/PCI

Significant

Death/MI/stroke/recurrent ischemia ( !

"#$% &$' es(p)*$*'%!

Death ( ! '$+ "$' ,o

MI ( ! ##$& %$- ,o

Stroke ( ! #$" #$" ,o

.ecurrent ischemia( !

#-$& -$* es(p)*$*'-!

LeMay M. American College of Cardiology 2004Scientific Sessions; Mar 7-10, 2004; Ne !rleans, LA.



,(-CI- ' trial '!!4

• ' ' pts#-MI ? 'hrs %Primary PCI with a$ci"ima$

%tenecteplase 5 eno"aparinfollowed $y C-, within '% ' hrs &interventions if indicated

• 3o di8erence in the infarct si*e or 26function at wAs

• 3o di8erence in the ma<or $leeding



:(-6E trial :averian (eperfusion-lternative Evaluation

• '/4 pts # ' hrs of symptom onset to facilitated PCI• ;alf dose reteplase 5 a$ci"ima$ or a$ci"ima$ alone• Primary endpoint infarct si*e estimation $y SPECT at /% ! days

after randomi*ation•

;igher incidence of TIMI III )ow in the infarct occluded artery inthe reteplase plus a$ci"ima$ group than in the a$ci"ima$ groupalone =.!1 vs 91# p?!@!! >

• 3o di8erence in the post PCI TIMI III )ow =90@'1 vs 9 @01# p!@ > or infarct si*e = 41 vs @/1>

• Ma<or $leeding /@ 1 =reteplase 5a$ci"ima$> vs @ 1=a$ci"ima$> # p o@

• ithin months after randomi*ation# the composite end point ofdeath# recurrent MI# or stroAe occurred in @.1 pts vs .@01



Tiro7$an given in the emergency room $eforeangioplasty= TI,E(% P-> pilot study% circulation '!!4

• !! acute MI pts# within ' hrs ofsymptom onset

• Tiro7$an in the emergency dept + cath la$

• Early administration asso withimprovement in the initial TIMI )ow grade

• Early administration of of tiro7$an is

feasi$le & safe # it improved theangiographic outcome in in pts with -MIundergoing PCI

• 4! day incidence of M-CE suggested $y

early administration of tiro7$an $ene7cial



ngoing tiro7$an in myocardial infarctionevaluation trial= n% TIME>

• /!0 pts with -MI # transferred to pci center# randomi*edto early prehospital initiation or late cath la$ initiaition oftiro7$an

• Primary end point# TIMI iii )ow at initial angio did not

di8er signi7cantly $etween the ' groups = vs /1#p!@''>• Throm$us or fresh occlusion !1vs 041 # p!@!!'• 4! day death 4@01 vs !@91• yr mortality .@/vs 4@01# p !@• Despite lower prevalence of throm$us or fresh occlusion#

early initiation of tiro was not asso with $ene7cial e8ectsin the post pci angiographic or yr clinical outcome



Facilitated intervention with enhanced reperfusionto stop events FI3ESSE trial -m heart < '!!.

=%ve results>• './' pts# 4 arm study# dou$le $lind # hrs of pain onset #

estimated time to cathla$ %. hrs# door to $alloon 4'mts %Primary PCI % Facilitated PCI with a$ci"ima$ alone % Facilitated PCI with reteplase+a$ci"ima$

• Primary endpointG Composite at ! days of all%causemortality+re hospitali*ation for CCF# resuscitated 6F morethan .9 hours after randomi*ation & cardiogenic shocA

• Secondary endpointsG• Complications of MI through ! days

– (e hospitali*ation for congestive heart failure – (esuscitated ventricular 7$rillation – Cardiogenic shocA



FI3ESSE Conclusions

• 3o signi7cant improvement in the endpointin pts treated with either a$ci"ima$%

facilitated PCI or reteplase+a$ci"ima$%facilitated PCI compared with primary PCI withadministration of a$ci"ima$ in the cath la$

• (eteplase+a$ci"ima$ administered early wasassociated with an increase in pre%PCI TIMI 4)ow and J 0!1 ST%segment resolution at !%

! minutes• Post%PCI TIMI 4 )ow and ST resolution at 9!%'.! minutes was similar in all 4 treatmentgroups



FI3ESSE $efore pci

-fter pci



FI3ESSE su$group analysis

• !1 pts entered in pci hospitals• -nalysis of pts with TIMI score K4#

within .hrs of symptom onset had areduction in ischemic events withfacilitated strategy

• Thus# for pts seen '%4 hrs ofsymptom onset# immediatethrom$olysis recommended # if PCIliAely to $e delayed



-ssessment of safety & eLcacy of a new treatmentstrategy for -MI %. =-SSE3T%.>trial lancet'!!

=%ve results in facilitated PCI>

• (andomi*ed trial # hrs of symptom onset# who werescheduled to undergo pci after a delay of %4 hrs#who were assigned to std pci=n% 949># pci preceded$y full dose tenecteplase=n 9' > B door% $alloon%

!mts• Premature termination higher inhospital mortality

in facilitated pci group• end point achieved in 1 in facilitated 41 in

the std pci group=(( @4 # /1 CIG @ % @0.BP@!!./>• Inhospital stroAe @9 vs !1#p ?!@!!• ;igher incidence of re infarction= 1vs .1 !@!'0 >#

target vessel revasculari*ation =01 vs 41 p @!!. >



-SSE3T%.

• Strategy of facilitated pci consisting of fulldose throm$olysis plus anti throm$otic cotherapy & preceding pci $y %4 hrs was

associated with worse clinical outcome thanprimary pci alone & cannot $e recommended

% -$sence of heparin infusion#

clopidogrel loading# prohi$ition of routine useof ,P II$IIIa antagonists

% Delay in throm$olytic therapy



Su$group analysis %-SSE3T .

• ./1 pts enrolled in the PCI hospitalswith a minimal pci related delay time

• These pts had a worst outcome withfacilitated strategy

• In contrast# pts who had a short timepain onset to throm$olysis='%4hrs>#who were given prehospitalthrom$olysis# had a trend towards$etter outcome with facilitated pci



Pharmacoinvasive trials



CARE&& IN AMI2'()300

*a"ilitated p"iVsMedi"al) res"ue

Com+ined endpoint lo,er in-a"ilitated p"i

EST4!.

Early 7$rinolyticsith or without

(outine rescue+ earlyinvasivevs primary pci

Similar end points

T(-3SFE( -MI

!/

T3N immediate pci

T3N rescue pci

Cardiovascular events

lower in thepharmacoinvasivegroup compared withstd care & rescue pci



The Com$ined -$ci"ima$ (eteplase Stent Study in-cute Myocardial Infarction =C-(ESS in -MI>

pharmacoinvasive

• compared a strategy of early transfer ofpatients to a PCI center after throm$olysis vsmedical treatment continued in the admittinghospital and transfer for rescue PCI only if therewas evidence of lacA of reperfusion

• Patients less than ' hours from symptomonset and with STEMI were randomi*ed to either

%% Facilitated PCI =lytics and transfer to thenearest PCI center>

%% Medical treatment+rescue =lytics and transferfor rescue PCI if persistent ST elevation>



• !! patients were randomi*ed to facilitated PCI=n ' 0> or to the medical+rescue =n 4!!>arms of the study

• time from pain onset to reteplase treatment was% 0 minutes

• time from reteplase administration to PCI was

4 mts in the facilitated arm vs ' ' mts in therescue arm• The com$ined endpoint of

death+reinfarction+refractory ischemia at 4! dayswas signi7cantly lower in the facilitated armcompared with the medical+rescue%treatedpatients

=.@ 1 vs @ 1# respectivelyB P @!! >



utcome Immediate PCI =1> (escue PCI=1> p

Death# re%MI#

refractory ischemiaat 4! days .@. !@0

!@!!.Ma<or $leed 4@. '@4

[email protected] StroAe !@0@4 !@/!



The EST = hich Early ST%ElevationMyocardial Infarction Therapy> trial

• 4!. patients%% 7$rinolytic therapy at the earliest contact =prehospitalor in referral hospital# with clopidogrel and eno"aparin>

with+without routine rescue or early invasive therapy

%% primary PCI• Tenecteplase and eno"aparin followed $y routine early

invasive therapy had similar death and MI rates toprimary PCI

• This supports the need for further trials to assess therole of optimal early 7$rinolytic therapy =includingprehospital> and antithrom$otic therapy versus primaryPCI in settings where very rapid PCI is not availa$le



(outine angioplasty after throm$olysisfor -MIG T(-3SFE(%-MI ne<m'!!

• !/ pts with high risA STEMI# at nonPCI center

• Full dose tenecteplase immediatetransfer for PCI

• tenecteplase transfer for rescuePCI

• Median time for PCI 4@ hrs='% hrs>



Inclusion Criteria T(-3SFE( -MI

• ithin ' hrs of symptom onset• K ' mm ST%segment elevation in ' anterior

leadsOR• K mm ST%segment elevation in ' inferior

leads and at least one of the followingG – S:P ? !! – ;( J !! – Nillip Class II%III – K 'mm ST%segment depression in anterior leads – K mm ST%segment elevation in 6 . (



Selected E"clusion Criteria

• Cardiogenic ShocA• PCI within month• Previous C-:,

• Primary PCI availa$le with DT: ? ! minutes• Ose of Eno"aparin in last ' hours in patient J 0/

years of age• Consent not o$tained within 4! minutes of T3N



Procedures

Cardiac Cath performed (%) Time- TNK to Cath (hrs)

PCI performed (%) Stent used (% of PCI cases) Time- TNK to PCI (hrs) PCI within 6 hrs of TNK (%) PCI within ! hrs of TNK (%)

"P II#$IIIa inhi#itor use (%) Time- TNK to "P II#$IIIa inhi# (hrs)I&'P use (%)C&'" performed (%)

Standard

Treatment(n *+)

+!!, ( . 6/)

6!/++ ( . ,0)

0+,

0 ( . 60)6+

Pharmacoin1asi1e

Strate23(n !!)

/,0 (!. )

+/+ (0. )+//,

,0 (0. ),6



*

!

6

+

*

!

6+

* * !* ! 0*

* 6

6 6

4a3s from 5andomi ation

% of Patients

Standard PCI 7 ! hrs (n /6)In1asi1e 8 6 hrs (n *+)

n=496n=508

422468

415466

415463

414461

414460

412457

Primary Endpoint: 30-Day Death, re-M ,!"#, $e%ere &e'(rrent )'hemia,

$ho'*

95 * 0, (* 06+. * ,+0): p * ** 0



Components of Primary Endpoint

4eath

5einfarction5ecurrent Ischemia4eath$;I$IschemiaNew $ worsenin2 C<=Cardio2enic Shoc>

StandardTreatment

(n /+)0 66 *! !

,!

! 6

Pharmacoin1asi1eStrate23(n !)

0 ,

0 0* !6! /

P-?a@ue

* /

* ** * /* *** *6/*



Summary

• Compared with QStandard TreatmentR# a

QPharmacoinvasive StrategyR of routineearly PCI within hrs after throm$olysisis associated with a 1 a$solute =. 1relative> reduction in the composite ofdeath# reinfarction# recurrent ischemia#heart failure and shocA

• The pharmacoinvasive strategy is notassociated with any increase intransfusions# severe $leeding orintracranial hemorrhage despite highuse of ,P II$+IIIa inhi$itors during PCI

• In contrast to older trials# routine early



Conclusions

• For high%risA STEMI patients receivingthrom$olysis at non%PCI centres# urgenttransfer and PCI within hours isassociated with signi7cantly less ischemiccomplications and no e"cess in $leeding

• Transfers to PCI centres should $einitiated immediately after throm$olysiswithout waiting to see whetherreperfusion is successful



(escue trials



Middles$rough early revasculari*ation tolimit infarction ME(2I3 trial U-CC '!!.

• 4!0 patients• DidnRt improve survival at 4! days• Improved event free survival• More stroAes# more $leeding complications• DidnRt result in preservation of 26 systolic function

at 4! days



ME(2I3 T(I-2 end points



(escue angioplasty vs conservative treatment orrepeat throm$olysis (E-CT trial# ne<m'!!/

• .'0 patients• Primary end points signi7cantly reduced in

rescue group



Coronary stenting vs $alloon angioplasty as a rescueintervention after failed throm$olysis in pts with -MI

ST P-MI . trial U-CC '!!.

• 9 patients#after failed throm$olysis# within '.hrs

=TIMI )ow 'during C-, >• Coronary stenting ! patients• :alloon angioplasty in patients• Salvage inde" = proportion of initial perfusion

defect salvaged $y rescue intervention> o$tained$y paired scintigraphic studies performed 0% !days apart was the primary end point



• Myocardial salvage inde" was signi7cantlygreater in the stent group =@4/ vs @'/#p @!!/> than in angioplasty group

• 3o di8erence in the ma<or $leeding• yr mortality was 91 vs '1• Pts with -MI# failed throm$olysis $ene7t

from rescue mechanical reperfusion interms of myocardial salvage

• Stenting asso with greater myocardialsalvage than $alloon angioplasty group



• Meta analysis of rescue PCI trials• (eduction in heart failure# reinfarction & a

trend towards lower mortality rate withrescue PCI

• -nother meta analysis of / randomi*ed trials%%4 1 reduction in risA of death# '91

reduction in the risA of heart failure#compared with the conservative group



(eperfusion strategy



• For patients presenting with high risASTEMI# who cannot undergo timelyprimary PCI # $est approach would $epre hospital throm$olysis# or localthrom$olysis at non PCI hospitals#followed $y transferring the patient

for PCI



ThanA you

facilitated pci vs rescue pci.pptx

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