Strategie di trattamento delle lesioni “non culprit” nelle SCA
Matteo VercellinoLaboratorio di emodinamicaASO AlessandriaOspedale SS. Antonio, Biagio e Cesare Arrigo
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
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
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
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.
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
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
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
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
Multivessel PCI in STEMI: past guidelines
Steg et al, Eur Heart J 2012
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
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%
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
GP, McCann et al. J Am Coll Cardiol 2015;66:2713–24
CRM CULPRIT subanalysis: non IRA infarction
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
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
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
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
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
COMPLETE trial: ESC 2019 and NEJM publication
Mehta S et al. NEJM 381(15):1411-1421
COMPLETE trial
Mehta S et al. NEJM 381(15):1411-1421
> 70% DS or > 50% DS in 2 + FFR≤0.80
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
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
Pay attention to the sample!
CTO 2.0%
Simple lesions
Mehta S et al. NEJM 381(15):1411-1421
FFR guided strategy<1%
COMPLETE TRIAL: safety endopoints
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).
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).
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
MULTISTAR AMI trial
ClinicalTrials.gov Identifier: NCT03135275
GE. Female. 75 Years oldCV risk factors→ NIDDM; Htx; dyslipidemia; 03.10.2019 lateral STEMI; 2V-CAD; FEVS 50%
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
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
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
Molte possibilità e pertanto poca chiarezza
T. Cuisset et al. EuroIntervention 2014;10-T47-T54
Heart team
Which issues could guide our choice
DM. Male. 52 Years oldCV risk factors→ Htx; Thrombocytosis; 08/2019 infero-posterior STEMI; 3VCAD; FEVS 45%
EES 4.0 x 18 mm
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%
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
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