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