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 115 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 2CAD 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 3CAD Trial Year
Incremental
in Review
Impact of New Research
PEGASUS AVOID ACCELERATE
MATRIX Chest Pain Choice PCSK9
PCI ACS Prevention
Trang 4CAD Trial Year
Incremental
in Review
Impact of New Research
TUXEDO LEADERS-FREE SPRINT MATRIX COSIRA PCSK9
Don’t Maybe Do
Trang 5l~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
ih.e ~:ii oe ~roup (h J!zm:I! ntio in theUt£5 of C'.l'!ro:iall'lrol 1'11 ~ (3.r:k With dtrolllOOllWCl'J' 'f'!i lS!l: Wjth !=Cl a.llm.Gj
1mn.t dtromClo;5is or illl~msel r~Jltn:31:ion ~.9lc "1i 9.8~ hhml fli!rlllJ l.00; 9!'1'Ar: Cl, o.B9 l1JJ 1.14; P.:.0.95)'l'IVE ILlm
sicn::ilwr ~ke: with.in 30 llaJ5 oc• ourre;t in B patil!nt!i (O.n) in th.e tlumrllie!:tom:, grou p 'JEfSU~ ff, p.i:til!nt!i {~
in tihe PCfilJDn.e fn:!up flt3z3rll riJ.:i,(], :2-0li, 9'n: G, '1.13 11:D 3.75; P=>0.02)
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,
cl?d not ml:ure lhe rsl:- of c:.an'.liCJT lltiJ3r d£3fh.,Jmull0lt rnyllC'lldi:il inllllt'Cti!ln, 1:3fdiclg0'Lie' aoor, or N'i}ilnass IV healt
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 60
Embolic protection
Manual thrombus aspiration
Mechanical thrombectomy
*Weighted Mean 5.0 months
Trang 7TOTAL 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 8Jolly et al Lancet 2015 Higuma JACC Card Int 2016;8:2002
Trang 9Jolly et al Lancet 2015
Trang 102013 ACC/AHA STEMI Guideline
Manual aspiration thrombectomy is reasonable for patients undergoing PPCI
Trang 112015 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 12w11a 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
jn-61 or IL!f!!fl"eclSN!llt Lmplurt1flo11,(n-f.O] Medi.la followsap ltbru!was 42rnontfu;{IQR 33-41Jj li>emsoornpnstng !he
prtmaJ)' endpeuu OCOIJTed lnJ 109 {111%1 pallents who Juel !il3lldard PO a11d In 1.05 ,[17%1 patJl!DtS wllo had dl!f!!fl"ecl Sll!ll t
~ - ~
,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
Hmvqlllbd:, Dein El-Hofstt11.l<l1fllr ~,amHr!qw,t lmell~ Lme fb'rrMlll!I E nt J ~ frants l't,fmni lilri5oow.Jmdi UIle ll\,d;rr; lillEJiilnglloo.s Fl(q,w.l,J111Wbl«1~KriA.k11111'111;\.1iif>Vcj.z,;.,~
HomE e.rt Clriot.iarJJTCl'tdK!\
[w ~H0rm""""'IJ'"' llmti1!~ Hon,,,H<rri"Tn1<'4l,lntonJl\l"""lf>nl.Ja,•Aa-"i .s n:1£ ,., , li<rrthmgo:nt l=tt~OJms<11
Pot,,-0,,m= ll'e,r C.-""'*',Jonl Mod'=\ a ti!lnTO')>l'<,f=<JJ11>,mw[ ngm,,rn
Sum marry
lla(j.k c11mlil Desplli! suc:a,ssul m1atml!Cl1 of the, rulpt11 tl!I)' lestoa "b)· prlmaty Jl'l!IOllaru!Oll'> onunarr 1m,l!Cl1Lon Mw.!C>5no
jPCII with s:taLt lmpl;mt1L1a.1arombo cemballsaL1cm o,crurs tn seme CISeS whc:b rmpnrs du!p:ngnosts ofp.111:ems Afd~.,n6
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
allocau we d.ld :mai}Sls II,· tme:mlon ta 1reat l11.Js ulaIs reipse:red wlth Clnllnals go,·number NCT01 ~8c MQFJI MQ
D O La.MD, L E m,g M Rl!ll r:igs Elelween March 1• znn and Feb 28,, 2JH4we, randcrm.ly assigned UIS patterns ta !Ea!h•e either standard PO J~MD,KN,-1,E,
anlllltiiv1rr9ntolC.~
1mplmtailan (IR,ard rarliJ o ·!19 9'5 Cl o · 76-1· 1 p,-0· 921- l'ro<l!!lwl!-relatoo l1\•oomllal 1E'.m:llllR bleedlag roqt1tr1a11 d K M i- M Q
111,msfasloo or SUJ:Bl!l)' c:antrZS1-lllduced aepaop;uby or StrOlie eccurred In.28 ,(5%) p.wellts Inihe ma-.·ooL1Dral PO ~ IYUap-11.1,n.,MD,
!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 13Primary 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 14BMS vs PTCA in AMI
De Luca et al Int J Card 2007;119:306
Trang 15Previous 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 16Excluded
To evaluate whether the prognosis of STEMI patients treated with PPCI
can be improved by deferred stent implantation
Trang 170 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 18560563
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 19Routine 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 20L 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 21Primary 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 223 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 23The 12-Month Primary Endpoint Composite
Gershlick, et al J Am Coll Cardiol 2015;65:963-972
Trang 24CvLPRIT 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 25Meta-Analysis of Recent Trials of
Complete Revascularization in STEMI
Complete vs Culprit-Only Revascularization
Trang 26Meta-Analysis of Recent Trials of
Complete Revascularization in STEMI
Trang 272013 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 282015 ACC/AHA/SCAI PCI Guidelines
Management of Patients with STEMI
PCI of a noninfarct artery may be considered in select STEMI patients without
Trang 29T<111 Oude Opl,ui._ P.1-D Ph.D J Wlllltcr Jukcnu M.D P.D Gal!l;a.na M D" Ferrari, M.D w·to1d ltuzflla D.
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