PCI for STEMI: Fix theCulprit Lesion, or Fix All of

JamesJames HermillerHermiller, MD, FACC, FSCAI, MD, FACC, FSCAISt Vincent Medical GroupSt Vincent Medical Group

St Vincent Heart Center of IndianaSt Vincent Heart Center of IndianaIndianapolis, INIndianapolis, IN

Culprit Lesion, or Fix All ofthe Lesions

Disclosure Statement of Financial Interest

• Grant/Research Support

• Consulting Fees/Honoraria

• Edwards, Medtronic, Abbott, StJude, BSC

• Edwards, Medtronic, Abbott, StJude, BSC

Within the past 12 months, I or my spouse/partner have had a financialWithin the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

• Consulting Fees/Honoraria • Edwards, Medtronic, Abbott, StJude, BSC

Outline

• Introduction

• The DATA

• Randomized Trials• Randomized Trials

• Guidelines

• Future Studies

• Summary

Introduction

• 64 year old man presentswith an acute inferior MI

• Prior history of HTN,• Prior history of HTN,hyperlipidemia andsmoking

• Hemodynamically stable

Introduction

Decisions

IntroductionTreat the IRA/RCA and then:

1. PCI LAD during admission only ifrecurrent symptoms or high risk stresstest?

2. PCI LAD during admission or planned2. PCI LAD during admission or plannedstaged intervention?

3. Fix both RCA and LAD at same sitting?

4. FFR LAD at time of primary RCA PCIand treat LAD during hospitalization ifFFR abnormal?

The DataThe Data

PRAMI Trial

NEJM 2013;369:1115

465 STEMI patients

Randomized following infarct-related artery (IRA)-PCI:

Complete revascularization (n=234) – preventative PCI

Culprit-only PCI (n=231) – no preventative PCI

Complete revascularization performed during indexPCI

PRAMI Trial

PCI

1o endpoint: Cardiac death, non-fatal MI or refractoryangina

2o endpoints: repeat PCI, non-cardiac death andindividual components of 1o endpoint

Trial stopped early, mean follow-up 23 months (465 ofthe anticipated 600 patient enrollment)

NEJM 2013;369:1115

1o endpoint: Cardiac death, non-fatal MI or refractory angina

PRAMI Trial

NEJM 2013;369:1115

PRAMI Trial

NEJM 2013;369:1115

PRAMI – Questions?• Five high volume centers in UK (each has > 300

PCIs per year) to enroll 465 patients (2428patients screened) between 2008 and 2003

• Highly selected/selection bias?

• How representative are these patients of those• How representative are these patients of thosewe treat? Generalizibility?

• If there had between 10 rather than 7 events inthe treatment arm, the MI difference would havebeen insignificant

• All 50% lesions or more were stented – whenelse is that done today?

CVLRPIT Trial

JACC 2015;65:963

CvLRPIT Trial 296 STEMI patients

Randomized open-label study

Patients with MVD randomized before IRA PCI to : Culprit-only IRA PCI (146 pts)

Complete revascularization PCI (150 pts)

At the time of PPCI

Staged during index admission

Randomization stratified for:

- site of infarct (anterior /non-anterior)

- Symptom onset to balloon time (≤3 hrs or >3 hrs)

1o outcome: MACE – total mortality/recurrent MI/heartfailure and ischemia- driven revascularization at 12months

JACC 2015;65:963

The primary endpointcomposite of total

mortality, recurrentMI, heart failure and

ischemia-driven

CVLRPIT Trial

ischemia-drivenrevascularisation at

12 months

JACC 2015;65:963

CVLRPIT Trial

JACC 2015;65:963

CvLPRIT – Questions?• Small study – sceened 850 patients over 48

months to enroll 296

• Mixed primary endpoint

• Cross-over

Patients with mutli-vessel disease and STEMI at• Patients with mutli-vessel disease and STEMI attime of cath were randomized during IRA PCI

• Of the 146 in the IRA only arm, 7 had completerevascularization

• Of the 150 in the complete revasc arm, 139 hadcomplete revasc, 7 had target IRA PCI only and 3had CABG

DANAMI-3 PRIMULTI Trial

Lancet 2015;386:665

627 STEMI patients

Randomized following infarct-related artery (IRA)-PCI:

Complete FFR-guided revascularization (n=314)

IRA -only PCI (n=313)

Complete revascularization performed as a stagedprocedure in hospital

DANAMI-3 PRIMULTI Trial

procedure in hospital

1o endpoint: All-cause mortality, nonfatal MI, ischemiadriven revascularization of non IRA lesions

2o endpoints: cardiac death, cardiac death/nonfatalMI, urgent PCI, non-urgent PCI and individualcomponents of 1o endpoint

Lancet 2015;386:665

DANAMI-3 PRIMULTI Trial

Primary endpoint:All-causemortality,nonfatal MI, andischemia driven

Lancet 2015;386:665

ischemia drivenrevascularizationof non IRAlesions

Individual components of primary endpoint

Composite Revascularisation

DANAMI-3 PRIMULTI Trial

Non fatal MI All cause death

Lancet 2015;386:665

Multivessel coronary disease diagnosed at the timeof primary PCI for STEMI: complete

revascularization versus conservative strategy.PRAGUE 13 trial

O. HlinomazO. HlinomazICRC, St. Anne University Hospital, Brno, Czech Republic

On behalf of the PRAGUE-13 Investigators

L. Groch, K. Polokova, F. Lehar, T. Vekov, R. Petkov, M. Stoynev, M. Griva, J. Sitar, M. Rezek,M. Novak, J. Semenka, N. Penkov, B. Gersh, D. Holmes, G. Sandhu, P. Widimsky

Grant IGA Czech Republic NT11412-5/2010, VAVPI EU ProjectNCT01332591

EuroPCR 2015

214 STEMI patients

Randomized following infarct-related artery (IRA)-PCI:

Complete revascularization (n=106)

IRA -only PCI (n=108)

Complete revascularization performed as a staged

PRAGUE-13 Trial

Complete revascularization performed as a stagedprocedure

Enrollment ≥48 hrs following onset of symptoms

1o endpoint: All-cause mortality, nonfatal MI, stroke

2o endpoints: cardiac death, all-cause death/nonfatalMI, hospitalization for angina, hospitalization for heartfailure

EuroPCR 2015

PRAGUE-13 TrialPrimary endpoint: All-cause mortality, nonfatal MI, stroke

Kaplan-Meier curve for primary composite endpoint

Pri

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p=0.407

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EuroPCR 2015

Conclusions: Complete revascularization of all significantcoronary lesions at the time of primary PCI was associatedwith a reduction in the risk of MACE due to reduction in therisk of urgent re- vascularization. This approach appears to besafe, with no excess major bleeding, or contrast-inducednephropathy.

Meta-AnalysisElgendy IY,et al, CCI. 2016:88;501-505

STUDY

Prague 13

DANAMI-PRIMULTI

CVLPRIT

PRAMI

Ghani

Polti

HELP AMI

OVERALL

Complete revasc associated withlower incidence of MI or mortality

Complete revasc associated withhigher incidence of MI or mortality

Contrast dose in CO vs MV PPCI:Increased Risk of CI-AKI

CO (cc) MV (cc) P value

PRAMI 200 (150-260) 300 (210-380) < 0.001

CVLPRIT 190 (150-250) 250 (190-330) < 0.0001

Wald DS, et al. N Engl J Med 2013;369:1115-23.Gershlick AH, et al. J Am Coll Cardiol 2016;65:963-72

Gurm, HS et al. J Am Coll Cardiol 2011;58:907-914

Overestimation of Non-Culprit StenosisSeverity in Setting of STEMI (n=122)

PPCI (n=507)

Only culprit-lesionPCI indicated (n=374

[74%])

Non-culprit lesion f/uindicated (n=122

[24%])

Complete MV PCI(n=11 [2%])

Thim T, et al. Open Heart 2016;3:000427

[74%]) [24%])

3 died

3 LTFU

Non-culprit lesion f/uperformed (n=116)

Revasc not

[33.6%])

Revasc notindicated (n=39

[33.6%])

PCI indicated(n=58 [50%])

CABG indicated(n=19 [16.4%])

Overestimation of Non-Culprit StenosisSeverity in STEMI (n=81)

Donmez E, et al. Int J Cardiovasc Imaging 2016;32:1471-1476

’Critically narrowed’ non–culprit arteries at time of PPCIdeemed ‘non-critical’ during control coronary angiography in

13.3%

Outline

• Introduction

• The DATA

• Randomized Trials• Randomized Trials

• Guidelines

• Future Studies

• Summary

Levine, et al. JACC. 2016:67; 125-1250.

Outline

• Introduction

• The DATA

• Randomized Trials• Randomized Trials

• Guidelines

• Future Studies

• Summary

The Ongoing Trialsn ImmediateStrategy

SubsequentStrategy

for UntreatedNon-Culprit

Lesions

FFRStrategy

COMPARE-ACUTE

800 Culprit Only vsFFR GuidedComplete

“GuidelineBased” PCI in

CulpritOnly Group

DS > 50% - FFR(blinded inculprit only

group)

COMPLETE

3000 Culprit OnlyIn Both Groups

Staged CompleteRevasc (PCI)

Within 6 weeks

DS 50-70% - FFRDS > 70% - Stent

FULLREVASC

4052 Culprit Only vsFFR Guided

Complete DuringIndex Admission

(Immediate orStaged)

“PRAMI”CONTROL

Symptom orischaemia drivenrevasc only. No

mandatoryischaemia testing

DS 50-90% - FFRDS > 90% - Stent

Key Points• Despite current guidelines, there is expanding evidence for the safety

and efficacy of routine multivessel PCI for STEMI patients.• FFR has incremental value for assessing stenosis severity in STEMI

patients with multivessel disease.• Further studies of vulnerable plaque are needed to obtain a complete

risk assessment in STEMI patients.

Outline

• Introduction

• The DATA

• Randomized Trials• Randomized Trials

• Guidelines

• Future Studies

• Summary

Summary

•• The optimal time for completeThe optimal time for complete revascrevasc….….

•• Immediate?Immediate? Staged duringStaged during index?index? Staged a fewStaged a fewdays/weeksdays/weeks later?later?

•• ShouldShould we targetwe target ischemicischemic lesions only using FFR?lesions only using FFR?

•• InIn other situations FFRother situations FFR--guidedguided revascrevasc isisassociated with a better outcomeassociated with a better outcome andandassociated with a better outcomeassociated with a better outcome andand

•• PCIPCI on nonon non--ischaemic lesions has an adverseischaemic lesions has an adverseoutcomeoutcome……

•• Is the real world population so different from theIs the real world population so different from thecarefully selectedcarefully selected groups ingroups in the RCTs that it isthe RCTs that it isimpossible to extrapolateimpossible to extrapolate to real practice?to real practice?

Conclusion

• In patients with STEMI and MVD, there isinsufficient evidence to support areduction in death/MI long-term with multi-vessel PCI

• Await the results of larger RCTs before• Await the results of larger RCTs beforemaking any definitive conclusionsregarding optimal revascularizationstrategy

• For now, PCI is acceptable in selectedpatients (FFR directed at time of staged?)– IIb indication

Case Review

Stented RCA

It’s 2AM --It’s 2AM -- FFR LADFFR LAD

Case Review

FFR LAD

Case ReviewLAD Undilatable – Rota/Stent Prior to

Discharge

Thanks for your attention!Thanks for your attention!