multivessel diseasein stemi: fixtheculpritand ......cto intervention after stemi. blinded evaluation...
TRANSCRIPT
Multivessel Disease in STEMI:FIXTHECULPRITand GOBACK
TOBED!
David Cox, MDFSCAI FACCLehigh Valley Health Network
Allentown PAControversiesand Advancements
2016
Disclosure
• Medical Advisory Board: Abbott Vascular,Boston Scientific, theMedicinesCompany
Lehigh Valley Hospital
2016 YTD 533 PCI 112 STEMI 21%
FY2016 1419 PCI 333 STEMI 23%
FY2015 1293 PCI 259 STEMI 20%
What we aren’t talking about
Why th is is Im p ortan t!
Mr. and Mrs . Z’s 50 th Wedding Annivers a ry
Asweet story no one should argue with
Challenging Dogma• Everyone in shock should get all
their arteriesopened: IRAculpritand all the rest
• Doesopeningnon-culprit artery withTIMI 3 flow and segmental normalwall motion improve shockoutcomes?
P rima ry Endpoint:
Morta lity a nd/or
S e ve re re na l fa ilure 30 da ys
CULPRIT-SHOCK Tria l
Patients in ca rdiogenic shockafte r AMI
Ka the te rla bor:PCI a ll re levant s tenoses
Group 2Culprit Les ion only PCI +
potentia l s ta gedReva scula riza tion
Check In- and exclus ion crite ria
Informed consent(4 diffe rent ve rs ions)
Randomiza tion
Cath lab:PCI culprit le s ion only
Group 1Immedia te Multives se l PCI
Not suitable :CULPRIT-SHOCK
Regis try
How to win thisdebate
• A COMMON PROBLEM
• 40-50%of patientswith STEMI haveMVdisease
• Nature of non-culprit disease: a mixedbag of challenges!
How to win thisdebate
• Me: Fix the culprit IRAwith a perfectresult
Leave the rest for thoughtfulapproach—LATER!
• Tim: Just fix them all after you fixthe infarct artery…..Don’t be lazy!
NON-IRA: What we don’t know
• Fix it during infarct
• Stent before discharge…..?FFR
• Stent in a few weeks…..? FFR
• Get a stress test and go fromthere
• Fix only if symptoms
Why NOTdo all the blockages?
Benefits
• Avoid risk of second procedure• Decrease infarct size by increasing
collateral flow?• Reduce recurrent MI?• Reduce length of stay?• Reduce recurrent ischemia?
Why NOTdo all the blockages?
• Increase infarct size
–Non-IRAPCI related no-reflow, ST
• Contrast induced nephropathy
• Increase cost with no clinical benefit
• Do they all need another PCI?
• Risks
Tim is tricky: Watch out for him!
• He will quote meta-analysesthat areflawed and confounded by includingobservation registriesor RCT’swithsmall trials!
• He will show multiple anecdotalexamplesto try and prove hispoint!
JAMA. 2014;312(19):2019-2027:
2015 ACC/AHA/SCAI Focus ed Updateon PPCI for Pa tien ts With STEMI
J Am Coll Cardiol 2016;67:1235-1250
2013 Recommendation 2015 Focused Update
Recommendation
Comment
Class III: Harm Class IIb
PCI should not be
performed in a
noninfarct artery at the
time of primary PCI in
patients with STEMI who
are hemodynamically
stable. (LOE:B)
PCI of a noninfarct artery
may be considered in
selected patients with
STEMI and multivessel
disease who are
hemodynamically stable,
either at the time of
primary PCI or as a
planned staged
procedure . (LOE: B-R)
Modified
recommendation
(changed class from III:
Harm to IIb and
expanded time frame in
which multivessel PCI
could be performed).
How to win thisdebate
• Why am I right?
• Common sense!
Overes timation of Non-CulpritS tenos is Severity in STEMI (n=81)
Donmez E, e t a l. Int J Cardiovasc Imaging 2016;32:1471-1476
’Critica lly na rrowe d ’ non–culprit a rte rie s a t time of P P CI
de e me d ‘non-critica l’ during control corona ry a ngiogra phy in 13.3%
Ove re s tim a tio n o f No n -Cu lp rit S te n o s isS e ve rity in S e ttin g o f S TEMI (n =122)
Thim T, e t a l. Open Heart 2016;3:000427
Contras t dos e in CO vs MV PPCI:Increas ed Ris k of CI-AKI
Wald DS, et a l. N Engl J Med 2013;369:1115-23.Gershlick AH, e t a l. J Am Coll Cardiol 2016;65:963-72
Gurm, HS et a l. J Am Coll Cardiol 2011;58:907-914
CO (cc) MV (cc) Pvalue
PRAMI 200 (150-260) 300 (210-380) < 0.001
CVLPRIT 190 (150-250) 250 (190-330) < 0.0001
Kevin R. Bainey, Shamir R.Mehta , Tony Lai, Robert C.Wels h
Ame rica n He a rt J ourna l,
Volume 167, Is s ue 1, 2014,
1–14.e 2
Confounded: Sicker patientswith MVdzget fixed ….more likely to expire
Wald DSet al. N Engl JMed 2013;369:1115-1123 Gershlick JAm Coll Cardiol. 2015 Mar 17;65(10
PRAMI Trial: 50%or >, Same setting
Variable Preventive
PCI(N=234)
Medical Rx
(N=231)
HR(95%CI) Pvalue
Cardiac death
or MI
11 27 0.36 (0.18-0.73 0.004
Cardiac Death 4 11 0.34 (0.11-0.73) NS
Wald NEJM 2013
Cvlprit Trial: 70%or >, imd or staged
Variable Medical Rx
(N=146)
PCI
(N=150)
HR(95%CI) P
value
All-cause
mortality
6 (4.1) 2 (1.3) 0.32 (0.06,
1.60)
0.14
Heart failure 9 (6.2) 4 (2.7) 0.43 (0.13,
1.39)
0.14
FFRto guide revascularisation in non-infarct related artery territories
• Randomised 627 STEMI patientsto receive culprit-only orcomplete revascularisation staged before DC.
• FFRused to guide N-IRAPCI in complete group• FFRused if lesion diameter stenosis50-90%.
50-90% DS all had FFR: Stent if ч 0.80
or
> 90%DS(no FFR)
DANAMI 3 – PRIMULTI Trial:FFR-Guided PCI reduced revasc with
no difference in death or MI
IRAonly(n =313)
Completerevascularisation
(n =314)HR[95%CI] p
All-causedeath 11(4%) 15(5%)1·4 [0·63–
3·0]0·43
Ischemia-drivenrevascularisation*
52 (17%) 17(5%)0·31 [0·18–
0·53]<0·001
So far, RCTnot definitive
• PRAMI: 5 years to recruit, excluded many,stopped early by DSMB
• Culprit: small, MACEpositive, not individualcomponents
• Danami-3: FFRdriven if 50-90%..1/3 50-90%FFRnot ischemic
• None address issue of safety re: go home andcome back
Primary endpoint according to severity of non-infarctrelated stenosis– DANAMI-3-PRIMULTI
Add DANAMI -3 and PRAGUE
Meta analyses less convincing
combined endpoint of death / recurrent myocardial infarction.
Me ta -An a lys is o f 7 RCTsMV vs . CO-P CI S tra te g y fo r S TEMI (n =1,939)
Elgendy IY, et a l. Ca the ter Cardiovsac Interv 2016;88:501-505
Clin ic a l Ou tc o m e sOutc ome Inc id ence (Comple te %/Culp rit %) RR 95% CI P-va lue I2%
Morta lity or MI 7.8/10.4 0.69 0.42–1.12 0.14 51
MACE 14.7/24.4 0.61 0.45–0.81 <0.001 54
All-causemorta lity
4.6/5.6 0.85 0.57–1.26 0.41 0
MI 5.2/6.0 0.74 0.38–1.44 0.38 49
Urgentrevascula riza tion
9.2/19.0 0.46 0.29–0.70 <0.001 61
Major bleeding 2.2/2.5 0.83 0.41–1.71 0.62 1
Contra s t-inducednephropa thy
1.6/1.7 0.94 0.42–2.12 0.89 0
Call MomIS Tim rea lly going
to a rgue we s hould fixa ll non-cu lprit b lockages
a t the s ame time ….bas edon thes e s mall RCT’s and
mx meta ’s I can ’tunders tand?
CTOdrivesexcessmortality in MVD
• CTO in non-IRA in 10%of STEMI patients
• Reduced LV function in MVD patients mainly driven by presence of CTO
Van der Schaaf e t a l, Heart, 2006Claessen et a l. JACC: Cardiovascular Interventions , 2009
s ubs tudy from the HORIZONS-AMI tria l
Claessen BE et alEur Heart J 2012
Explore Trial Design
Patients with
STEMI + CTO
LVEFand LVEDV
MRI at 4 month
• De s ig nGloba l, multi-cente r, randomized, prospectivetwo-arm tria l with e ithe r PCI of the CTO or noCTO inte rvention afte r STEMI.Blinded eva lua tion of endpoints .
• P a tie n ts
Patients with STEMI trea ted with pPCI andwith a non-infa rct re la ted CTO.
• Ob je c tive
CTO-PCI < 7d No CTO-PCI
1:1
To de te rmine whether PCI of the CTOwithin 7 days afte r STEMI results in ahigher LVEF and a lower LVEDVassessed by MRI a t 4 months
Henriques JPet al, JACC, 2016
EXPLORETrial Outcome
- Early CTO-PCI :
- not associated with higher LVEFand lower LVEDV @ 4 months
Henriques JPet al, JACC, 2016
CTO-PCI in the LAD was associated with higher LVEF@ 4 months
47.2±12.3%vs. 40.4±11.9%, p=0.02
Henriques JPet al, JACC, 2016
COMPLETEStudy Design
Ongoing Trials
n Immediate
Strategy
Subsequent Strategy
for Untreated Non-
Culprit Lesions
FFR
Strategy
COMPARE-
ACUTE
800 Culprit Only vs
FFRGuided
Complete
Guideline Based
PCI in Culprit
Only Group
DS> 50%- FFR
(blinded in culprit
only group)
COMPLETE 3900 Culprit Only
In Both Groups
Staged Complete
Revasc (PCI)
Within 6 weeks
DS50-70%- FFRDS> 70%- Stent
FULL
REVASC
4052 Culprit Only vs
FFRGuided
Complete During
Index Admission
(Immediate or
Staged)
PRAMI CONTROL
Symptom or
ischaemia driven
revasc only. No
mandatory
ischaemia testing
DS50-90%- FFRDS> 90%- Stent
STEMI
Significant N-IRA lesion
Will the patient be better off/worse offif it is treated with PCI?
Final thoughtsWhat I have to concede to Tim:
meta of 7 RCT’sshowsno increase inCIN with MVPCI same settingorbefore DC
What Tim has to concede to me:
If Danami 3 isright and 31%of 50-90%lesionsare FFRnegative…..we willbe doinga lot of unnecessary stenting!
Final thoughts
• No one trial will likely settle thisdebate
• BEA DOCTOR..No-Reflow in IRA, don’t ’play with fire in non-IRA!
• At least we have some data to makechoices and not end up in Guideline-Jail
• More powerful studieson the way
Most of my call nights…
See what Tim comesup withBut I think….I won!