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CAD Trial YearIncremental in Review Impact of New Research PEGASUS AVOID ACCELERATE LEADERS-FREE TOTAL SPRINT MATRIX Chest Pain Choice PCSK9 PCI ACS Prevention DAPT CULPRIT HOPE-3... CAD

Trang 1

15 th National Congress of Cardiology

Hanoi, Vietnam, October 9-11, 2016

Coronary Artery Diseases Year in Review

2015-2016 Five Trials That Will Impact Patient Care

Gregory W Barsness, MD, FACC, FAHA, FSCAI Consultant, Internal Medicine & Cardiology and Radiology

Director, Mayo Clinic EECP Laboratory Director, Mayo Clinic Cardiac Intensive Care Unit

Mayo Clinic College of Medicine

Rochester, MN, USA

Nothing to Disclose Related to this Talk

Trang 2

CAD Trial Year

Incremental

in Review

Impact of New Research

PEGASUS AVOID ACCELERATE LEADERS-FREE TOTAL SPRINT

MATRIX Chest Pain Choice PCSK9

PCI ACS Prevention

DAPT CULPRIT HOPE-3

Trang 3

CAD Trial Year

Incremental

in Review

Impact of New Research

PEGASUS AVOID ACCELERATE

MATRIX Chest Pain Choice PCSK9

PCI ACS Prevention

Trang 4

CAD Trial Year

Incremental

in Review

Impact of New Research

TUXEDO LEADERS-FREE SPRINT MATRIX COSIRA PCSK9

Don’t Maybe Do

Trang 5

l~I ~~~~~~~ o_ n_ r r._ ,_ r N_A_ 1_ A_ R_ T_ 1c_,n_ F~~~~~~ '11

In patients w it h S T EMI who were under g oing pri m ar y P CI , r outine m a n al throrn •

b ecto my , a s comp a re d w i th PC I alone, did no t redu c e the ris k of c a rd i o va scul a r

de a t h > recurrent m y oc a rdial i nfar c t o , c ar d l o ge nic

failure w i th i n 1 8 0 d a ys but w as a ss o ci a ted with a n

s hock > or inc r e sed Ins t it ut es

S.S:.Jal1y; JA ~·ms, S YLl5l.lf; 16 Meeks JPogue, M J Rc,'kaoss, S Ki::t:b,

L Th.lb.ii~ G Stanlu:rwic., R Mc.r<!!n.o, A G~rshld:, S diawdli:a.ry, Sl 2w'~

K Niemel~ P.G Steg I Bi:m:a.t, Y.Xu, WJ.C;mlc>r C.B Owerg;md., C.K N;iber,

JI N dieem:i R.C W~,n OF ll.!!rtu1n:I.A.Jl.~um It BhindL S Pan.chol,-

S.\I ho 1.U( N~t~rajan,J.M.ten !Rrg 0 S~u, P Gc30, Widimsk,,

;iin:I V D:h.vlk for the TOTAL lrr,,utipmrs*

d w i th PC I alone, did no t redu c e the ris

M edtronic a nd the C a na d i a n Ins t it ut es

11: D LT !i

Th.e: pr'rm31'J' i:tutllDCru!OCCUl'il'«I in 3Q ofsml p3timl! C6 9l,J rn the: ih.rc!llloo:timlJ' group '1ll1111-li 351 eseao pati£nl! Cl.Die) in

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C CII C LV.S J Q I U

111 p:!liet.ts wirh STl!Jilil ~·ho we-e nnlfergoing [Pfloli!laJf PCI, routine m.:rn.11a! th.[D(llf• bel:MJC1LT, as c0Illj)i!J8111•ith PC! alon.e,

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llriiu rewidi.i;n 1EO dzjs tlu.t ~'al§ l!.cSS003bell '!ith an ini:rea5eil rate of c51fDkewith.i;n

Mt ,d.J.fii (Pun.d'.ed lly MOO:lfOn.ic 311.cl th.e Onarli:m lnstitutBS of He:ilrh ~.TOTAi a inie.'!.ffi'iaJ~ m moo, Menn U'!I044.J

Trang 6

0

Embolic protection

Manual thrombus aspiration

Mechanical thrombectomy

*Weighted Mean 5.0 months

Trang 7

TOTAL Trial Flow and Adherence

10,732 enrolled and randomized

10,066 underwent PCI for STEMI

5033 Manual Thrombectomy

5030 PCI Alone

Cross-over to Thrombectomy as inital

Trang 8

Jolly et al Lancet 2015 Higuma JACC Card Int 2016;8:2002

Trang 9

Jolly et al Lancet 2015

Trang 10

2013 ACC/AHA STEMI Guideline

Manual aspiration thrombectomy is reasonable for patients undergoing PPCI

Trang 11

2015 ACC/AHA STEMI Guideline

Routine aspiration thrombectomy is not useful

before PPCI

I

Usefulness of selective and bailout thrombectomy in PPCI is not well established

I

Trang 12

w11a ST-s:eipnem el·at1n m)11Cll'dlal Lnf.uollon (STEMI) we armed to assess the dnl:C1l autCllllles of d.eferreds:e.m

1mpla111at.1011v:m1s seandard PC! la palll!ll:tswth STIMI

Metnol!s wdldl dtl5 Ol]el1-bb!l :randomtsed controllc.:l.1111al alilllll' IJl;!mar,, rc1 Cl!Cllrl!!l tn Di!runJirlc El~i!, aa1tents ,., ,, o,mm

i nterpretat j on In p a t e nt s wi th S T M I , ro u n e d eferr ed st en t i m a n t at i on di n t r ed u ce th e occurr e nc e of d ea t h ,

on g oin g ra n dom i s e d t r i al s mig h t s h e d f u rth e r l ig ht o n the conce pt of d e f e rred sten t ing i n th is p a

[- ,;11,1111

N ,, ,., ll T D,

.- -llmpt,,I

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~ - ~

,l!r!,us ll ,(4%) pat1l!Cl In the def ed srl!Cl1 lmpl.1m31100 grmip.wlla no :51R111£icmt mlferencl!5 betwel!D ·groops

lllterpll!taUon ta partems with STEM I, llllllllll!! dl!ferredl 5tem 1m;plama1lon did 11111 reduce: dte ocrurramEof dl!Jih ~ Ea.p",1,.11 .iy,

l.1"cf'~ E fio<l.r Mon~ag randomtsed u!a.ls might shed fwlhl!,fllgllt on the macepi o! dr1!!Tedsiemrng In ts Jmlffit ])lllllllatl

10 both redua! tlu"ombus burden and tncrease111)-oa:nl!al lnla~ [STEM I]." , Ho:-'er; In :same

D efer r e d v e r sus co nv en t i o a l st e t i mplan t at i on i n p at i e nt s

w it h ST - s e gme n t e l ev at i on my oca r d i a l ln f a rc tl o (D ANAMI 3 - DEF E R.): a n o pe n - l a e l, r a dom i sed con t ro ll e d t r i a l

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Sum marry

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anlllltiiv1rr9ntolC.~

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!lop-al~hear1 fil11e CTl)·ocardlal 1r.1rn100 or Tl!pl!a\ Tl!l•il!Ollall.Siltlon oornpaTl!d w'111 con,-ea11.0n.Jl !'Cl IR15alt!; from A i ,A.a& ,.o-,,,.,i, C I T W l,l;l

Trang 13

Primary PCI vs. Fibrinolysis

2.2 2

0 0

Death Re-MI Rec

Isch

Total stroke

Hem stroke

Major bleed

Death

MI Stroke

NNT = 17 NNT = 50

Trang 14

BMS vs PTCA in AMI

De Luca et al Int J Card 2007;119:306

Trang 15

Previous Deferred Stenting Studies

Adverse Outcome of Stent in PPCI

Distal embolization occurs in 7% of cases

_ Non-randomised

Meneveau Isaaz Tang Cafri Ke Pascal

78 93 87 106 103 279

Procedural success*

TIMI 3 TIMI frame count thrombotic events MACE

101 140

no-/slow fow MVO (% of LVmass)

Trang 16

Excluded

To evaluate whether the prognosis of STEMI patients treated with PPCI

can be improved by deferred stent implantation

Trang 17

0 1 2 3 4 5

Time (years) Number at risk

Conventional 612 568 533 360 159 0

Deferred 603 543 526 359 156 0

Trang 18

560563

391395

167172

00

587559

561549

387382

170167

00

0 1 2 3 4

5

Number at risk

Hospitalisation for heart failure

Recurrent myocardial reinfarction B

Conventional HR: 1.1 [0.69 - 1.64];

P=0.77Deferred

Trang 19

Routine deferred stenting was associated with

an increased rate of target vessel revascularisation, mainly due to premature

stent implantation

Unplanned target vessel revascularisation D

5

2

0

C o n v e nt io n al

H R: 1 7 [1 0 4 - 2 9 2] ; P = 0 0 3 0 Deferred ce 2

n 0

e d 5

ci 1 n i 0 ve i 0 t a 1

l 0 m u 5

Components of the Primary Endpoint and PRIMACY may add clarity Prompt reperfusion and (drug-eluting) stent placement is warranted in PPCI C 0 0 Bottom Line Current practice of PPCI is difficult to improve upon with current technology DEFER is underpowered: minimal signal (LVEF) INNOVATION Prompt reperf placeme and PRIMACY may nt is warranted in 0 1 2 3 4 5

Time (years) Number at risk Conventional 612 587 561 387 170

0

Deferred 603 559 549 382 167

0

Trang 20

L es i on-O nl y Revascu l ar i zat i on i n Pa t i ent s

ra t e of th e co rn po sl te prima ry en d po i nt at 1 2 m o nt h s co mpared w i h t re at i n go n l y th I RA I n suc h pat i ent s,

in pa tie nt t o t al re v ascul a z at i o n ma y be co n si de re d , b ut L rg er dl ni ca l t r ia Ls a re ire q i IB d t o co nfi rm th is res u

s s t rata gy is a ss i ated w it h im ro v ed survi v al ( C o nn pl et V ersu s Les i o -on l y im a ry PC I P i Lot S.t u: cly

IS.RCTN709B60 5) ( J A m C o ll Ca r d iol 2015;65 : 9 63, - 72 ) © 2 015 by th A mer ic a n Co ll eg e o f C ar d i

[ Cv L PR ll];

lnpSt e nt tat.alre,,;;isauizatlm may be mmklere:I but larger dinlcat mats.are reqwedto cmfinn thJsregiand~

Random i zed Tr i a l of Comp l e t e Versus .

U n e rgo i ng Pr i mary Percutan e ous Corona r y I nt erven ti on f or STEMI and M ul t i vesse l D ease

T e Cv LP I T Tr i a l

Anthony H Gerablick, MBBS,• Jam Nasir Kba.n MB Ot!B,• D.ami.:m l Kelly ?.ffi oe, MD,

John P Greenwood, MB OIB, PKD, t~ 1h.i,agar.ajah Sasika:ra.n BSc , PH!D, 11 Nick Curzei, Bl>.{ P:HO

Thmiel l lUackman., MD,~ iles Dalb, MBBS, MD,t KatJ:u:ynL airbmther, BA,0 W ston Banya, MSc,ft

Duol.ao Wang, PHD n Ma.n:w Fther,MB BS.}~ Simon 1- Hetherington MB oe , MD JI II

Andre.YD Ke.lion, BM BO!., DM,1'1 Sul!l!l T:a.lwar MB BS, MD.II Ji.tlrk Guiming, MD.'"' Roger H3Jl, MD.~

Howa.ni Swanton MB BO!!R, MD ttt Ge.n:y PMcCa.nn MB C!!.B, MD•CONCLUSIO S

MnMCIDW Afm1h!yplOIM!d-'m.ZW!llt unl!nN!ntmmnaryangloglaplly2, gf! padffl1s 7U.C t'Mtt!l5wtrl!

ranloomlzed throu,gh an orte;-act:M! volce-leSpOOiS!! program to elthe1111-lla;ptal am p'e te re,,,.aiO!JlaJtz.a tlon (n - 150) or

IR-orty revasaJlariz.atm (n - 1'6) Ccmj:l.et revas.artariz.atm was peifooned eithe r at the time of P·PCI or bef«e

~Jtald6dwge, R.andomiz.aboo wa stratified by 111.t:am loc.atim (Mtenor/oonantel'lOf) and :l)'mptool OIISl!!t {:£3 h

o, =-3 hJ The pnl!Ul''.Ji ~w:as a COfT\l)051lte d all-cau.se ~a1h reaurm.tmyocardial ,nf:arction(Mii) hea f~

.and ls.dlemi.a-driven revas.rularlz.atlon wrthj12 mooths

IR.E.SULTS Pa nt g-wpswe1ewEilmatdiedfor~clLnk.ald!Mactensth lhe pnmary !!!fld;pwttocaurein1.0%

of the COlff\P'l!!te revas.oularlz.auoogroup ~,s, 2.2% in the I RA-oo.fy re asculanzaoon ~ {hazaid ratio, 45.: 95coo.fidence llter.at0.2to 0.84: p - 0.009) A trend wward bene1it was seen e.3!ly afte, complete re ascuhfaatioo(p- 0.055 a30 days).lthooghthere was nos4gn.tfic.ant redtctm Indeathor Ml a n.cns.,gnJfic.atredoctkn ,n all;inmary

endpo,.fltCOfllj)Of1elt:s was :s,een lhere 'Illas no redue1iloo kl isdlemburden oo ll"l)OCardatpe.rfu;SMlfl s.an1lgralfly a 111th-e

s.afet)' ~ts d fn¥W bl.eedng, cut1astilll!dtud nephropathy, or strob! bet en th! group;

co NOLus IO:NS Inpatientspl!S!!!lltllgf« P-PCI v.th multM!~dl>!!a;e.adel: aitru.slon IDl!lpleterevas.aJarizat bn Sl!ll(lf

bntl)'bwere:lthe rate of the ~pnmaiyel1od,poont atl2 mm.1ru.mmpared'llll1h tu t,ngonl)'1fle IRA dlpat.!!llts,

address""'1Elher t lti suateg), s ~tedwlth mi:ro-t su-,,i.,a(Complete Verst5 Les.lm-mPnrnaJ)' PCI lo: :Study

[C~ rtJ: ISRCTN,0913605) (J Am~ ardol.2CHSi6S,91i3-72j 11:l :.,0151\, the Ama'ic;,n CdlegeoQrdld.ogy FOJflidltloo

Trang 21

Primary PCI Angiogram

IRA

MVD in 30 - 60% of STEMI Higher mortality than single vessel

Culprit lesion PCI improves outcome

Is immediate non-culprit artery PCI indicated?

Trang 22

3 IRA only and referral for CABG

Randomized (during IRA PCI)

Stratified Anterior/ non-anterior Sxs

<3hours/>3hours

STEMI with MVD

>70% single view / >50% two views

Trang 23

The 12-Month Primary Endpoint Composite

Gershlick, et al J Am Coll Cardiol 2015;65:963-972

Trang 24

CvLPRIT Conclusions

55% MACE reduction with PPCI + Non-IRA lesion(s)

on index admission with no adverse safety signal

compared with IRA-alone

Gershlick, et al J Am Coll Cardiol 2015;65:963-972

Does not answer primary question of appropriate timing or identification of suitable lesions for

staged PCI

Trang 25

Meta-Analysis of Recent Trials of

Complete Revascularization in STEMI

Complete vs Culprit-Only Revascularization

Trang 26

Meta-Analysis of Recent Trials of

Complete Revascularization in STEMI

Trang 27

2013 ACC/AHA/SCAI PCI Guidelines

Management of Patients with STEMI

PCI should not be performed in a noninfarct artery at the time of primary PCI in patients without hemodynamic compromise

Trang 28

2015 ACC/AHA/SCAI PCI Guidelines

Management of Patients with STEMI

PCI of a noninfarct artery may be considered in select STEMI patients without

Trang 29

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