B.G. 62 aa. Fumatore attivo, IA, dislipidemia

2009 SCA Malattia a. circonflessa : PTCA con stent “metallico”(BMS)

27/12/2013Ricovero programmato per TE positivo 75 W

28/12/2013Coronarografia : restenosi subocclusiva intra-stent arteria circonflessa prox ; lesione 50% c destra ; IVA “irregolarità”Angioplastica PCI: impianto di DES (tecnica “stent in stent”)

30/12/2014Dimissione . Asa 100, Clopidogrel 75, bisoprololo 2,5 , atorvastatina 20

B.G. 62 aa.

05/01/2014 ore 14:00 dolore tipico a riposoore 14:30 giunge in DEA (Pescia)con mezzi propri (!)

B.G. 62 aa.

05/01/2014 ore 15:30 entra in Sala di Emodinamica al San JacopoCoronarografia per via radiale destra

Diagnosi:Occlusione trombotica in ingresso stent:“Trombosi Subacuta di Stent”

Trattamento :In DEA :eparina 5000 U evIn Emodinamica Carico orale PrasugrelAvanzato catetere Export:Reo-Pro (Abcximab) i.c. & Trombectomia manuale

Fine art of thrombus suction in STEMI !February 29, 2012 by dr s venkatesan

B.G. 62 aa.

05/01/2014 ore 15:45 Trombectomia

B.G. 62 aa.

05/01/2014 ore 15:50 ripristinato flusso TIMI 3

2)Trattamento:

PTCA palloncino , con distensione alta pressione dello stent

B.G. 62 aa.

05/01/2014 ore 17:00 in reparto Liv 1 S.I.

Stent ThrombosisStent Thrombosis(ARC Definite + Probable)(ARC Definite + Probable)

0

1

2

3

0 30 60 90 180 270 360 450

HR 0.48P <0.0001

Prasugrel

Clopidogrel2.4

(142)

NNT= 77

1.1 (68)

Days

En

dp

oin

t (%

)

Any Stent at Index PCIAny Stent at Index PCI N= 12,844 N= 12,844

R I V A L

NSTE-ACS and STEMI(n=7021)

Radial Access(n=3507)

Femoral Access(n=3514)

Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days

Randomization

RIVAL StudyRIVAL Study Design Design

Key Inclusion: •Intact dual circulation of hand required•Interventionalist experienced with both (minimum 50 radial procedures in last year)

Jolly SS et al. Am Heart J. 2011;161:254-60.

Blinded Adjudication of Outcomes

R I V A L

Site of Non-CABG Major Bleeds Site of Non-CABG Major Bleeds (RIVAL definition)(RIVAL definition)

*Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH, Pericardial Tamponade and Other

0.25 1.00 4.00 16.00

Radial better Femoral better

High MediumLow

High MediumLow

High MediumLow

HighMediumLow

HighMediumLow

0.021

0.013

0.538

0.019

0.003

Interactionp-valueHR (95% CI)

Primary Outcome

Death, MI or stroke

Non CABG Major Bleed

Major Vascular Complications

Access site Cross-over

Results stratified by Results stratified by High*, Medium* and Low* Volume Radial CentresHigh*, Medium* and Low* Volume Radial Centres

R I V A L

No significant interaction by Femoral PCI center volume

Tertiles of Radial PCI Centre Volume/yr

*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)

Impact of Therapies on OutcomesImpact of Therapies on Outcomes

BleedingBleedingIschemic events:Ischemic events:

MI/CKMB↑MI/CKMB↑Stent ThrombosisStent Thrombosis

Bleeding and MortalityBleeding and Mortality

Major Bleeding

TransfusionHypotension

Ischemia Stent Thrombosis Inflammation

Mortality

Cessation of ASA/Clop

Bhatt DL. In Braunwald EB, Harrison’s Online. 2005.

HORIZONS: 1-Year All-Cause Mortality

Number at riskBivalirudin aloneHeparin+GPIIb/IIIa

1800 1705 1684 1669 15201802 1678 1663 1646 1486

Mo

rtal

ity

(%)

0

1

2

3

4

5

Time in Months

0 1 2 3 4 5 6 7 8 9 10 11 12

Bivalirudin alone (n=1800)

Heparin + GPIIb/IIIa (n=1802) 4.8%

3.4%

HR [95%CI] =

0.69 [0.50, 0.97]

P=0.029

3.1%

2.1%

Δ = 1.0%

P=0.049

Δ = 1.4%

Mehran R et al. Lancet 2009:on-lineMehran R et al. Lancet 2009:on-line

1.8

8.3

1.8

4.9

0

2

4

6

8

10

12

Reinfarction Major bleeding*

30 d

ay e

vent

rate

s (%

)Heparin + GPIIb/IIIa inhibitor (N=1802)Bivalirudin monotherapy (N=1800)

HORIZONS: 30 Day Adverse Events

*Not related to CABG*Not related to CABG** Plat cnt <100,000 cells/mm** Plat cnt <100,000 cells/mm33

P<0.001P<0.001

P = 0.90P = 0.90

Stone GW et al. NEJM 2008;358:2218-30Stone GW et al. NEJM 2008;358:2218-30

1:11:1

1:11:1

NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker

NSTEACS or STEMI with invasive managementAspirin+P2Y12 blocker

Trans-Femoral Access

Heparin±GPI

BivalirudinMono-Tx

StopInfusion

Prolong≥ 6 hs infusion

1:11:1

Trans-Radial Access

Is TRI superior to TFI ?

Is Bivalirudin superior to UFH ?

Should Bivalirudin be prolongedafter PCI ?

MATRIX TrialMATRIX Trial NCT01433627

http://www.cardiostudy.it/matrix

paziente

procedura farmacologia

Rischio ischemico

vs

Rischio emorragico

Trattamento delle SCA

AccessoTrombectomiaStentingIABPNuovi devices

ASA +ClopidogrelASA + nuovi bloccanti 2Py12Uso selettivo dei GP2b3aEparina vs Bivaluridina

MATRIX

TrialMATRIX

Trial

B.F. 76 aa

Familiarità per CI, IA, DM tipo 2, dislipidemia

25/10/2013: dolore toracico tipico insorto a riposo

FMC (118) ad un ora circa dall’esordio .

Diagnosi ecg di IM anteriore (ST sopra V2-V5)

“door to balloon (D2B)” time di 75 min

Coronarografia : stenosi “significativa” TC, occlusione trombotica di IVA, stenosi critica 75% “ulcerata” di C.dx prossimale, arteria CX indenne

B.F. coronarografia sinistra

Occlusione IVA

Stenosi TC

B.F.Angioplastica primaria tramite trombectomia ed impianto di stent (DES)

IVA

B.F….Ad un mese (11/12/2013) controllo con “IVUS” su TC …..

Stenosi TC

Stent di IVA

IVUS : intra vascular ultra sound

….Ad un mese (13/12/2013) controllo con “IVUS” su TC….

Stenosi TC

Stent di IVA

IVUS : intra vascular ultra sound

….Ad un mese controllo con “IVUS” su TC : MLA 4,2 mm2

Stenosi TC

Stent di IVA

IVUS : intra vascular ultra sound

Area luminale minima 4,2 mm2Valori cut off per TC 6,0 mm2

Stent su TC

Stent su IVA

B.F. (14/12/2013) PCI di TC mediante impianto di stent su TC-IVA

Stent su TC

Stent su IVA

B.F. (13/12/2013) PCI di TC mediante impianto di stent su TC-IVA

25/10/2013

Stent su C destra

PCI di c destra con impianto di stent DES 1° tratto

Stent C. destra

Ottimizzazione tecnica impianto “Clear Stent”

0

5

10

15

20

25

30

0 3 6 9 12 15 18 21 24 27 30

Months of Follow-up

PROVE-IT TIMI-22PROVE-IT TIMI-224,162 Randomized Pts with ACS4,162 Randomized Pts with ACS

16% RR16% RR

P = 0.005P = 0.005

Pravastatin 40 mg/dPravastatin 40 mg/d

Atorvastatin 80 mg/dAtorvastatin 80 mg/d

26.3%26.3%

22.4%22.4%

Dea

th, M

I, U

A r

equ

irin

g h

osp

, D

eath

, MI,

UA

req

uir

ing

ho

sp,

reva

sc >

30d

, or

stro

ke (

%)

reva

sc >

30d

, or

stro

ke (

%)

Cannon CP et al. NEJM 2004;350:1495-1504Cannon CP et al. NEJM 2004;350:1495-1504

How many events were attributable to: 1) Restenosis, stent thrombosis, etc. vs. 2) Significant disease left behind, vs. 3) VP with rapid lesion progression?

How many events were attributable to: 1) Restenosis, stent thrombosis, etc. vs. 2) Significant disease left behind, vs. 3) VP with rapid lesion progression?

ACSACSmedian 7dmedian 7dPCI 69%PCI 69%

• We therefore performed a prospective, We therefore performed a prospective,

multicenter natural history study using 3 vessel multicenter natural history study using 3 vessel

multimodality intracoronary imaging to quantify multimodality intracoronary imaging to quantify

the clinical event rate due to atherosclerotic the clinical event rate due to atherosclerotic

progression and to identify those lesions which progression and to identify those lesions which

place pts at risk for unexpected adverse place pts at risk for unexpected adverse

cardiovascular eventscardiovascular events

• We therefore performed a prospective, We therefore performed a prospective,

multicenter natural history study using 3 vessel multicenter natural history study using 3 vessel

multimodality intracoronary imaging to quantify multimodality intracoronary imaging to quantify

the clinical event rate due to atherosclerotic the clinical event rate due to atherosclerotic

progression and to identify those lesions which progression and to identify those lesions which

place pts at risk for unexpected adverse place pts at risk for unexpected adverse

cardiovascular eventscardiovascular events

The The PROSPECTPROSPECT TrialTrial

BackgroundBackground

700 pts with ACS700 pts with ACSUA (with ECGUA (with ECGΔΔ) ) oror NSTEMI NSTEMI oror STEMI >24º STEMI >24º

undergoing PCI of 1 or 2 major coronary arteriesundergoing PCI of 1 or 2 major coronary arteries

at up to 40 sites in the U.S. and Europeat up to 40 sites in the U.S. and Europe

PCI of culprit lesion(s)PCI of culprit lesion(s)Successful and uncomplicatedSuccessful and uncomplicated

Formally enrolledFormally enrolled

Metabolic S.Metabolic S.• Waist circumWaist circum• Fast lipidsFast lipids• Fast gluFast glu• HgbA1CHgbA1C• Fast insulinFast insulin• CreatinineCreatinine

BiomarkersBiomarkers• Hs CRPHs CRP• IL-6IL-6• sCD40LsCD40L• MPOMPO• TNFTNFαα• MMP9MMP9• Lp-PLA2Lp-PLA2• othersothers

PI: Gregg W. StonePI: Gregg W. StoneSponsor: Abbott Vascular; Partner: VolcanoSponsor: Abbott Vascular; Partner: Volcano

The The PROSPECTPROSPECT TrialTrial

3-vessel imaging post PCI3-vessel imaging post PCICulprit artery, followed byCulprit artery, followed by

non-culprit arteriesnon-culprit arteries

Angiography (QCA of entire coronary tree)Angiography (QCA of entire coronary tree)

IVUSIVUS

Virtual histologyVirtual histology

Palpography (n=~350)Palpography (n=~350)

Repeat imagingRepeat imagingin pts with events in pts with events

Meds recMeds recAspirinAspirinPlavix 1yrPlavix 1yrStatinStatinRepeat biomarkersRepeat biomarkers@ 30 days, 6 months @ 30 days, 6 months

Proximal 6-8 Proximal 6-8 cm of each cm of each coronary coronary

arteryartery

Proximal 6-8 Proximal 6-8 cm of each cm of each coronary coronary

arteryartery

MSCTMSCTSubstudySubstudyN=50-100N=50-100 F/U: 1 mo, 6 mo,F/U: 1 mo, 6 mo,

1 yr, 2 yr,1 yr, 2 yr,±3-5 yrs±3-5 yrs

F/U: 1 mo, 6 mo,F/U: 1 mo, 6 mo,1 yr, 2 yr,1 yr, 2 yr,±3-5 yrs±3-5 yrs

The The PROSPECTPROSPECT TrialTrial

Lesions are classified into 5 main typesLesions are classified into 5 main types

1.1. Fibrotic Fibrotic

2.2. Fibrocalcific Fibrocalcific

3.3. Pathological intimal thickening (PIT)Pathological intimal thickening (PIT)

4.4. Thick cap fibroatheroma (ThCFA) Thick cap fibroatheroma (ThCFA)

5. 5. VH-thin cap fibroatheroma (VH-TCFA)VH-thin cap fibroatheroma (VH-TCFA)(presumed high risk)(presumed high risk)

PROSPECT:PROSPECT: Methodology Methodology

Virtual histology lesion classificationVirtual histology lesion classification

Index 2/13/06Index 2/13/06 Event 2/6/07Event 2/6/07

QCA PLCX DS 28.6%QCA PLCX DS 28.6% QCA PLCX DS 71.3%QCA PLCX DS 71.3%

PROSPECT 82910-012: PROSPECT 82910-012: 52 yo♂52 yo♂

2/13/06: 2/13/06: NSTEMI, PCI of MLADNSTEMI, PCI of MLAD

2/6/07 (51 weeks later): 2/6/07 (51 weeks later): NSTEMI attributed to LCXNSTEMI attributed to LCX

38

1. ThCFA1. ThCFA

*OM

5.3mm2

LesionLesion

*

1

prox

PROSPECT 82910-012: PROSPECT 82910-012: Index 2/13/06Index 2/13/06

Baseline PLCXBaseline PLCXQCA: RVD 2.82 mm, QCA: RVD 2.82 mm, DS 28.6%, length 6.8 DS 28.6%, length 6.8

mmmmIVUS: MLA 5.3 mmIVUS: MLA 5.3 mm22

VH: ThCFAVH: ThCFA

PROSPECT: PROSPECT: MACEMACEM

AC

E (

%)

MA

CE

(%

)

Time in YearsTime in Years00 11 22 33

All All Culprit lesion (CL) relatedCulprit lesion (CL) relatedNon culprit lesion (NCL) relatedNon culprit lesion (NCL) relatedIndeterminateIndeterminate

00

55

1010

1515

2020

2525

Number at riskNumber at risk

ALLALL 697697 557 557 506 506 480480

CL relatedCL related 697697 590590 543543 518518

NCL relatedNCL related 697697 595595 553 553 521521

IndeterminateIndeterminate 697697 634634 604 604 583583

12.9%12.9%

20.4%20.4%

11.6%11.6%

2.7%2.7%

PROSPECT:PROSPECT: Multivariable Correlates Multivariable Correlates of Non Culprit Lesion Related Eventsof Non Culprit Lesion Related Events

Independent predictors of lesion level Independent predictors of lesion level events by logistic regression analysisevents by logistic regression analysis

Variables entered into the model: Minimal luminal area (MLA); plaque burden at the MLA (PBVariables entered into the model: Minimal luminal area (MLA); plaque burden at the MLA (PBMLAMLA); );

external elastic membrane at the MLA (EEMexternal elastic membrane at the MLA (EEMMLAMLA) <median; lesion length ≥ median (mm); VH-TCFA.) <median; lesion length ≥ median (mm); VH-TCFA.

VariableVariable OR [95% CI]OR [95% CI] P valueP value

PBPBMLAMLA ≥70% ≥70% 4.99 [2.54, 9.79] <0.0001<0.0001

VH-TCFA VH-TCFA 3.00 [1.68, 5.37] 0.00020.0002

MLA ≤4.0 mmMLA ≤4.0 mm22 2.77 [1.32, 5.81] 0.0070.007

Lesion length ≥11.6 mmLesion length ≥11.6 mm 1.97 [0.94, 4.16]] 0.070.07

EEMEEMMLAMLA <14.3 mm <14.3 mm22 1.30 [0.62, 2.75]] 0.490.49

I LIMITI DELLA CORONAROGRAFIA NELLO STUDIO DELL’ATS I LIMITI DELLA CORONAROGRAFIA NELLO STUDIO DELL’ATS CORONARICA (MALATTIA DI PARETE)CORONARICA (MALATTIA DI PARETE)

IVUS=intravascular ultrasound

Angiogram IVUS

Little evidence of disease

Atheroma

No evidence of disease

The IVUS technique can detect The IVUS technique can detect angiographically ‘silent’ angiographically ‘silent’

atheromaatheroma

NEW

Reproduced from Circulation 2001;103:604–616, with permission from Lippincott Williams & Wilkins.

RIMODELL.POSIT.