strategie di trattamento delle lesioni “non culprit ...€¦ · 2 muller dw et al. am heart j...
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Strategie di trattamento delle lesioni “non culprit” nelle SCA
Matteo VercellinoLaboratorio di emodinamicaASO AlessandriaOspedale SS. Antonio, Biagio e Cesare Arrigo
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1 Jong JA al. Coronary Artery disease 20062 Muller DW et al. Am Heart J 19913 Wald et al. NEJM 20134 Gershlick et al. ESC 2014
Multivessel PCI in SCA: rationale?
CL/culprit
NCL/non culprit
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The lesson from PROSPECT trialMACE = cardiac death, cardiac arrest, MI, or rehospitalization for unstable or progressive angina
Providing Regional Observations to Study Predictors of Events in the Coronary Tree. G. Stone et al
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Independent predictors of lesion level events
Providing Regional Observations to Study Predictors of Events in the Coronary Tree. G. Stone et al
Variables entered: minimal lumen area (MLA), plaque burden at the MLA, external elastic membrane at the MLA, lesion length, distance from the coronary ostium to the MLA,
remodeling index, thin-cap fibroatheroma, insulin-requiring diabetes and prior percutaneous coronary intervention
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Multivessel PCI in STEMI
CL/culprit lesion
NCL/non culprit lesion
1) CULPRIT ONLY
REVASCULARIZATION/con
servative strategy
2) COMPLETE
REVASCULARIZATION
STAGED/
intermediate strategy
Rivascolarizzazione solo in casodi recidiva dei sintomi o test
provocativi positivi(Eco/Scinti/Ergo/CRM)
Rivascolarizzazione guidatada angiografia/FFR, in altra
seduta durante ricoverooppure dopo dimissione
(media 30 giorni).
3) COMPLETE
REVASCULARIZATION-
IMMEDIATE/
aggressive strategy
Rivascolarizzazione nellastessa seduta guidatadall’angiografia/FFR.
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SF. Male. 71 Years oldCV risk factors→ Htx; dyslipidemia; 03.10.2019 subacute inferior STEMI; 3V-CAD; FEVS 35%;
Moderate MR
Self-expandable SES medium 37 + large 27
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SF. Male. 71 Years oldCV risk factors→ Htx; dyslipidemia; 03.10.2019 subacute inferior STEMI; 3V-CAD; FEVS 35%;
Moderate MR
LAD + deferred CDX stent post-dilata tion 4 days after hospital admission
EES 3.25 x 23 mm
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SF. Male. 71 Years oldCV risk factors→ Htx; dyslipidemia; 03.10.2019 subacute inferior STEMI; 3V-CAD; FEVS 35%;
Moderate MR
CTO after 2 months and stress echo +
Gaia 1-microcatheterZES 2.5 x 38 mm
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Pros and Cons of each strategy
NCL overestimation: 20% of NCL ≥50% in the acute phase become subcritical in the FUP
T. Cuisset et al. EuroIntervention 2014;10-T47-T54
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Multivessel PCI in STEMI: past guidelines
Steg et al, Eur Heart J 2012
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Vlaar Metanalysis: etherogeneity of results
Vlaar et al. J Am Coll Cardiol. 2011;58:692-703
Discrepancies between the
results of retrospective and
prospective randomized
studies
Four prospective and 14 retrospective studies involving 40,280 patients were included
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PRAMI trial: open label RCT about preventive PCI
DS Wald et al. N Engl J Med 2013;369:1115-23.
Primary Eps→23% culprit only vs 9% “preventive PCI”
group; ARR=14%.
DS≥50%
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DS Wald et al. N Engl J Med 2013;369:1115-23.
CULPRIT trial10% CR arm; 21.2% IRA-only arm;HR
MACCE: 0.45; IC95%: 0.24-0.84; p=0.009
> 70% DS or > 50% DS in 2 views
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GP, McCann et al. J Am Coll Cardiol 2015;66:2713–24
CRM CULPRIT subanalysis: non IRA infarction
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News from PRAMI and CULPRIT→shift from the theory of unstable plaque to the theory of unstable patient
Unsolved issues- Which the role of imaging and functional tecniques (FFR, IVUS, OCT)
in the NCLs evaluation?- Which benefit on hard endpoint like death or MI?→need of large RCT
adequately powered?- Which is the right time to complete (immediate, staged in hospital;
staged within 30 days, 60 days etc….)
PRAMI/CULPRIT: open questions
Gershlick H.A. et al J Am Coll Cardiol 2015;65:963–72
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DANAMI 3 PRIMULTI trial: the role of FFR
Lancet 2015; 386: 665–71
; Median FUP=27 month (12-44).
13% CR FFR guided; 22% IRA-only arm;HR MACCE: 0.56; IC95%: 0.38-
0.83; p=0.009
> 50% DS and FFR <0.80 or > 90% DS
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PC, Smits et al. NEJM 2017;376: 1234–44
COMPARE Acute: the role of FFR
Primary EP: 8% in FFR CR arm VS 21% in conservative arm (HR ratio, 0.35; 95% CI, 0.22 to 0.55; P<0.001)
> 50% DS and FFR <0.80
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PRAMIWald NEJM 2013
CvLPRITGershlick JACC 2015
D3-PRIMULTIEngstrom Lancet
2015
COMPARE ACUTE Smits NEJM 2017
Pt (n) 465 296 627 885
Strategy for non-IRA lesions
Immediate Immediate (64%) or staged within index admission (36%)
FFR; staged within index admission
FFR; immediate (84%) or staged
within index (16%)
Lesion criteria > 50% DS > 70% DS or > 50% DS in 2 views
> 50% DS and FFR <0.80 or > 90% DS
> 50% DS and FFR <0.80
Age 62 years 65 years 64 years 62 years
Non Anterior MI 67% 65% 66% 65%
Primaryendpoint
D/MI/refractoryischaemia
D/MI/HF/isch D R D/MI/isch D R D/MI/isch D R/CVA
FUP 23 month (67%) 12 months 27 months 12 months
Result 23% to 9% 21% to 10% 22% to 13% 21% to 8%
Early Benefit Yes Yes Safe to postpone Yes
Effect on hard endpoints
Yes (CV death p=0.07,
MI p<0.05)
No No No
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As the optimal timing ofrevascularization (immediatevs. staged) has not beenadequately investigated, norecommendation in favourof immediate vs. stagedmultivessel PCI can beformulated.
Multivessel PCI in STEMI: new guidelines
Ibanez et al, Eur Heart J 2018;39:119-77
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COMPLETE trial: ESC 2019 and NEJM publication
Mehta S et al. NEJM 381(15):1411-1421
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COMPLETE trial
Mehta S et al. NEJM 381(15):1411-1421
> 70% DS or > 50% DS in 2 + FFR≤0.80
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Cumulative Incidence of the First and Second Co-primary Outcomes
Mehta S et al. NEJM 381(15):1411-1421
158 patients (7.8%) in the complete-group VS
213 patients (10.5%) in the culprit-lesion-only PCI group
179 patients (8.9%) in the complete-revascularization group VS
339 patients (16.7%) in the culprit-lesion- only PCI group
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Primary EP driven by MI and IDR reduction
Mehta S et al. NEJM 381(15):1411-1421
Complete revascularization in 90.1% after NCL PCI
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Pay attention to the sample!
CTO 2.0%
Simple lesions
Mehta S et al. NEJM 381(15):1411-1421
FFR guided strategy<1%
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COMPLETE TRIAL: safety endopoints
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Timing substudy: CV death and MI
D.A. Wood et al Volume 74, Issue 22, December 2019
Randomization was stratified according to investigator-planned timing of NCL PCI: during (mean 1 dats after PPCi) or after the index hospitalization (mean 23 days after PPCI).
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Timing substudy: CV death, MI, IDR
D.A. Wood et al Volume 74, Issue 22, December 2019
Randomization was stratified according to investigator-planned timing of NCL PCI: during (mean 1 dats after PPCi) or after the index hospitalization (mean 23 days after PPCI).
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Ongoing trials intermediate vs aggressive
PRAMI 2013 & CvLPRIT 2015
COMPARE-ACUTE 2017
DANAMI – 3 – PREMULTI 2015 MULTISTARS AMI
Non-IRA lesion?
CONSERVATIVEOMT
INTERMEDIATEnon-IRA PCI
STAGED
AGGRESSIVEnon-IRA PCIIMMEDIATE
Ischemia-drivenrevascularization
FFR*Based
angiographybased
FFR*based
angiographybased
COMPLETE 2018
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MULTISTAR AMI trial
ClinicalTrials.gov Identifier: NCT03135275
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GE. Female. 75 Years oldCV risk factors→ NIDDM; Htx; dyslipidemia; 03.10.2019 lateral STEMI; 2V-CAD; FEVS 50%
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GE. Female. 75 Years oldCV risk factors→ NIDDM; Htx; dyslipidemia; 03.10.2019 lateral STEMI; 2V-CAD; FEVS 50%
EES 2.25 X 28 mm
CONTRAST MEDIUM 240 CC
EES 3.0 X 16 mm + KB
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Ongoing trials including NSTEMI
PRAMI 2013 & CvLPRIT 2015
COMPARE-ACUTE 2017
DANAMI – 3 – PREMULTI 2015
Non-IRA lesion?
CONSERVATIVEOMT
INTERMEDIATEnon-IRA PCI
STAGED
AGGRESSIVEnon-IRA PCIIMMEDIATE
Ischemia-drivenrevascularization
FFR*Based
angiographybased
FFR*based
angiographybased
COMPLETE 2018
BioVasc (STEMI and NSTEMI)
FULL-REVASC
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shift from the theory of unstable plaque to the theory of unstable patient
(Un)solved issues
- Which the role of imaging tecniques (FFR, IVUS, OCT)in the NCL evaluation?
- Which benefit on hard endpoint like death or MI?→need of large RCT adequately powered?
- Which is the right time to complete (immediate, staged in hospital; staged within 30 days, 60 days etc….)
Open question
Gershlick H.A. et al J Am Coll Cardiol 2015;65:963–72
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Molte possibilità e pertanto poca chiarezza
T. Cuisset et al. EuroIntervention 2014;10-T47-T54
Heart team
Which issues could guide our choice
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DM. Male. 52 Years oldCV risk factors→ Htx; Thrombocytosis; 08/2019 infero-posterior STEMI; 3VCAD; FEVS 45%
EES 4.0 x 18 mm
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DM. Male. 52 Years old
BPAC AMI sx→IVA; AMI dx “Y” graft MO
CV risk factors→ Htx; Thrombocytosis; 08/2019 infero-posterior STEMI; 3VCAD; FEVS 45%
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H. Thiele. N Engl J Med 2017;377:2419-32.
• Ibanez et al. Eur Heart J 2018;39:119-177• Neumann et al. Eur Heart J 2018;epub
25.08.2018
Cardiogenic shock: change of paradigm after CULPRIT
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Matteo VercellinoLaboratorio di emodinamicaASO AlessandriaOspedale SS. Antonio, Biagio e Cesare Arrigo
Thank you for your attention…
Strategie di trattamento delle lesioni “non culprit” nelle SCA