Jose Mª de la Torre HernandezUnidad de Cardiologia Intervencionista

Hospital Universitario Marques de ValdecillaSantander

IVUS/OCT como guía del intervencionismo

coronario

La importancia del diagnostico basal

Una angioplastia exitosa comienza por una adecuada indicación y un

correcto diagnostico

Lesiones Intermedias

Lesiones TRONCO

Lesiones Ostiales

Bifurcaciones

Segmentos con “flou”

Imagenes ambiguas

Re-estenosis

400 pts 400 pts

FFR IVUS

Centro-FFR vs. Centro-IVUSCentro-FFR vs. Centro-IVUS(De la Torre Hernandez, Lopez Palop, et al. )

FFR < 0.75MLA < 3,5 - 4 mm2 (based on vessel size) and PB > 50%

EuroIntervention. 2013 May 20.(Epub ahead of print)

11 estudios , incluyendo 2 en tronco (TC) (total N= 1759 pacientes, 1953 lesiones)

El corte ponderado medio fue 2.6 mm2 en estudios no-TC y de

5.5 mm2 en estudios en TC

En lesiones no-TC, el ALM mostro:Sensibilidad = 79%Especificidad = 65%

En lesiones de TC el ALM mostro: Sensibilidad = 90%Especificidad = 90%

11 estudios , incluyendo 2 en tronco (TC) (total N= 1759 pacientes, 1953 lesiones)

El corte ponderado medio fue 2.6 mm2 en estudios no-TC y de

5.5 mm2 en estudios en TC

En lesiones no-TC, el ALM mostro:Sensibilidad = 79%Especificidad = 65%

En lesiones de TC el ALM mostro: Sensibilidad = 90%Especificidad = 90%

Precision diagnostica del ALM obtenido por IVS comparado con el FFR

- Meta-analisis -

Precision diagnostica del ALM obtenido por IVS comparado con el FFR

- Meta-analisis -

FFR Significacion

IVUS Presencia de placaCantidad de placaReduccion luminalCalcioMorfologia (complicada ?)Remodelado Extension enfermedad (vaso total)

Lesiones intermediasFFR-Estenosis bien definidas 40-70%IVUS-Lesiones irregulares (ulceradas, disecadas...)-Defectos contrastacion (nodulares, lineales…)-Posibles artefactos (ostium tronco, ostium CD…)-No bien visualizables (tri-bifurcaciones, superposiciones de ramas,…)

Luz minima ?Significativo ???

ALM = 3 mm2

ALM = 3 mm2

ALM = 6 mm2

TC

Proximal DA

Proximal CxJasti et al. Circulation 2004;110:2831-6

Linear law (epicardial coronary artery)

Do = 0.678*(D1+D2)

Finet G et al. Eurointervention 2007;3:10-17

De la Torre et al. J Am Coll Cardiol 2011;58(4):351-8

Validación prospectiva de ALM = 6 mm2 como corte para revascularizacion del TC en nuestra población

354 pacientes en 22 centros

En que nos ayuda el IVUS para mejorar los resultados de la ICPEn que nos ayuda el IVUS para mejorar los resultados de la ICP

Hematoma

Hallazgos de IVUS en el stent

Enf. bordes

Rotura stentProlapso placa

Subexpansion AposicionIncompleta

Diseccionen margenes

Problemas mas comunes

Diseccion bordeSubexpansionAposicion Incompleta

IVUS en reestenosis de BMS/DES : ImplicacionesImplicaciones TerapeuticasTerapeuticas

Predomina

Subexpansion

Predomina

Prolif. intimal

Fractura

stent

IVUS Predictores de Trombosis y Reestenosis precoz con BMS

Trombosis precoz

Reestenosis

SubexpansionSubexpansion •Cheneau et al. Circulation 2003;108:43-7

•Kasaoka et al. J Am Coll Cardiol 1998;32:1630-5•Castagna et al. AHJ 2001;142:970-4•de Feyter et al. Circulation 1999;100:1777-83•Sonoda et al. J Am Coll Cardiol 2004;43:1959-63•Morino et al. Am J Cardiol 2001;88:301-3•Ziada et al. Am Heart J 2001;141:823-31•Doi et al. JACC Cardiovasc Interv. 2009;2:1269-75

Problemas de borde Problemas de borde (“geographic miss”, carga de (“geographic miss”, carga de placa alta, disecciones,… etc)placa alta, disecciones,… etc)

•Cheneau et al. Circulation 2003;108:43-7

•Sakurai et al. Am J Cardiol 2005;96:1251-3•Liu et al. Am J Cardiol 2009;103:501-6

Longitud stentLongitud stent •Kasaoka et al. J Am Coll Cardiol 1998;32:1630-5•de Feyter et al. Circulation 1999;100:1777-83

Impacto de la longitud de lesion y area minima intrastent sobre la reestenosis

de Feyter et al. Circulation 1999;100:1777-83de Feyter et al. Circulation 1999;100:1777-83

Final Minimum Stent Area (mm2)

Stent L

ength

(mm

)Res

ten

osi

s (%

)

**

**

*

**

* **

** *

***

******

*

**

**

.1 1 10

TULIP

DIPOL 

Gaster

RESIST

SIPS

AVID

OPTICUS

Favors Non-IVUSFavors IVUS Odds Ratio

Combined (RE)Combined (FE)

MACE

Meta-analisis de Trials IVUS vs Angiografia en implantacion de BMS (n=2.193 pts)

El uso de IVUS se asocio a menos:•Reestenosis Angiografica •(22.2% vs. 28.9%; p=0.02)•Revascularizacion Repetida (12.6% vs. 18.4%; p=0.004)•MACE •(19.1% vs. 23.1%; p=0.03)

Parise et al. Am J Cardiol. 2011;107:374-82

Predictores en IVUS para trombosis y reestenosis de DES

Trombosis precoz Reestenosis

SubexpansionSubexpansion •Fujii et al. J Am Coll Cardiol 2005;45:995-8)•Okabe et al., Am J Cardiol. 2007;100:615-20•Liu et al. JACC Cardiovasc Interv. 2009;2:428-34•Choi et al. Circ Cardiovasc Interv 2011;4:239-47

•Sonoda et al. J Am Coll Cardiol 2004;43:1959-63•Hong et al. Eur Heart J 2006;27:1305-10•Doi et al JACC Cardiovasc Interv. 2009;2:1269-75•Fujii et al. Circulation 2004;109:1085-1088•Kang et al. Circ Cardiovasc Interv 2011;4:9-14•Choi et al. Am J Cardiol 2012;109:455-60•Song et al. Catheter Cardiovasc Interv, in press

Problemas de borde Problemas de borde (“geographic miss”, (“geographic miss”, carga de placa alta, carga de placa alta, disecciones,… etc)disecciones,… etc)

•Fujii et al. J Am Coll Cardiol 2005;45:995-8•Okabe et al., Am J Cardiol. 2007;100:615-20•Liu et al. JACC Cardiovasc Interv. 2009;2:428-34•Choi et al. Circ Cardiovasc Interv 2011;4:239-47

•Sakurai et al. Am J Cardiol 2005;96:1251-3•Liu et al.Am J Cardiol 2009;103:501-6•Costa et al, Am J Cardiol, 2008;101:1704-11

Predictores-IVUS de reestenosis con DES

Hong et al Eur Heart J 2006;27:1305-10

> 40 > 40 < 40< 40

< 5.5< 5.5

> 5.5> 5.5

Comparado con angiografia, el uso de IVUS en el implante de DES se asocio a menos:

Muerte (HR: 0.58, 95% CI: 0.47-0.71, p<0.001)

MACE(HR: 0.85, 95% CI: 0.76-0.95, p=0.005)

Trombosis de Stent(HR: 0.62, 95% CI: 0.46-0.83, p=0.002)

No efecto en IM

No efecto en TLR

Study Year Death HR (95% CI) Weight %

0.10.1

.1.1

11

1010

100100

Favors IVUS Favors Non-IVUS

P Roy SJ Park SH Kim

J Jakabcin JS Kim

BE Claessen SH Hur

K Ahmed Overall

20082009201020102011201120112011

20082009201020102011201120112011

0.81 (0.55, 1.20)0.39 (0.15, 1.02)0.21 (0.06, 0.73)

1.50 (0.15, 15.42)0.58 (0.21, 1.61)0.74 (0.37, 1.47)0.49 (0.35, 0.69)0.49 (0.28, 0.86)0.58 (0.47, 0.71)

0.81 (0.55, 1.20)0.39 (0.15, 1.02)0.21 (0.06, 0.73)

1.50 (0.15, 15.42)0.58 (0.21, 1.61)0.74 (0.37, 1.47)0.49 (0.35, 0.69)0.49 (0.28, 0.86)0.58 (0.47, 0.71)

28.004.762.800.804.219.1936.3813.86

100.00

28.004.762.800.804.219.1936.3813.86

100.00

MACE

0.10.1

.1.1

11

1010

100100

Favors IVUS Favors Non-IVUS

P Agostoni P Roy

SJ Park J Jakabcin

JS Kim BE Claessen

SH Hur K Ahmed

Overall

20052008200920102011201120112011

20052008200920102011201120112011

0.40 (0.05, 2.91)0.90 (0.71, 1.15)0.64 (0.39, 1.05)0.92 (0.37, 2.28)0.73 (0.44, 1.20)0.77 (0.56, 1.06)0.76 (0.62, 0.93)1.07 (0.86, 1.33)0.85 (0.76, 0.95)

0.40 (0.05, 2.91)0.90 (0.71, 1.15)0.64 (0.39, 1.05)0.92 (0.37, 2.28)0.73 (0.44, 1.20)0.77 (0.56, 1.06)0.76 (0.62, 0.93)1.07 (0.86, 1.33)0.85 (0.76, 0.95)

0.3120.595.091.494.9512.0329.7525.76

100.00

0.3120.595.091.494.9512.0329.7525.76

100.00

Stent Thrombosis

0.10.1

.1.1

11

1010

100100

Favors IVUS Favors Non-IVUS

P Roy SJ Park

J Jakabcin SH Kim

BE ClaessenJS Kim SH Hur

Overall

2008200920102010201120112011

2008200920102010201120112011

0.59 (0.39, 0.89) 3.00 (0.12, 76.85)0.67 (0.15, 3.00)0.28 (0.06, 1.28)0.60 (0.10, 3.51)0.33 (0.04, 2.96)0.72 (0.44, 1.17)0.62 (0.46, 0.83)

0.59 (0.39, 0.89) 3.00 (0.12, 76.85)0.67 (0.15, 3.00)0.28 (0.06, 1.28)0.60 (0.10, 3.51)0.33 (0.04, 2.96)0.72 (0.44, 1.17)0.62 (0.46, 0.83)

50.500.823.823.732.751.7936.59

100.00

50.500.823.823.732.751.7936.59

100.00

Zhang et al. Eurointervention, 2012;8:855-65

Meta-Analisis de estudios (n=19.619)

EuroIntervention 2012;8: published online ahead of print October 2012 EuroIntervention 2012;8: published online ahead of print October 2012

EstudiosconPropensityMatching

EstudiosconPropensityMatching

Estudiossin tronconi SCA

Estudiossin tronconi SCA

Eventos Clinicos a 12 meses

Constantini et al TCT 2008

IVUS mejora resultados clinicos

RESET trialEn el subgrupo de lesiones largas ( ≥28mm

longitud stent en vasos ≥2.5mm), los pacientes se randomizaron a IVUS vs solo angiografia

Kim JS, JACC Cardiovasc Interv. 2013 Apr;6(4):369-76.

IVUS-guidance

Angiography-guidance

RR p

N 297 246

MACE (cardiac death, MI, ST, TVR)

4.0% 8.1% 0.48 (0.23-0.99) 0.048

Patel Y. Am J Cardiol 2012;109:960

225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance.

After propensity score adjustment, IVUS use was associated with significantly lower rates of the composite of cardiovascular death, MI, or TLR, composite MI or TLR and MI compared with no IVUS.

The use of IVUS was also associated with a trend towards a lower rate of TLR.

Conclusions: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events

225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance.

After propensity score adjustment, IVUS use was associated with significantly lower rates of the composite of cardiovascular death, MI, or TLR, composite MI or TLR and MI compared with no IVUS.

The use of IVUS was also associated with a trend towards a lower rate of TLR.

Conclusions: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events

Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with

complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels).

The study included 284 patients.The primary study end point (MLD stent) showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %)

CONCLUSIONS:A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months

Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with

complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels).

The study included 284 patients.The primary study end point (MLD stent) showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %)

CONCLUSIONS:A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months

Outcomes in 145 propensity-matched pairs of patients receiving DES with and without IVUS guidance

Park S et al. Circ Cardiovasc Interv 2009;2:167-177

The Korean experience

IVUS guidance decreased mortality

Mortality

Death + MI TVR

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled

analysis at patient level of 4 registries. 

Jose M de la Torre Hernandez, MD, PhD, José Antonio Baz Alonso, MD, Joan Antoni Gómez Hospital, MD, PhD, Fernando Alfonso, MD, PhD, Tamara Garcia Camarero,

MD, Federico Gimeno de Carlos, MD, PhD, Gerard Roura Ferrer, MD, Angel Sanchez Recalde, MD, Íñigo Lozano Martínez-Luengas, MD, PhD, Josep Gomez Lara, MD, Felipe Hernandez, MD, María José Pérez-Vizcayno, MD, Angel Cequier Fillat, MD,

PhD, Armando Perez de Prado, MD, Agustín Albarrán, MD, Manuel Jimenez Navarro, MD, PhD, Josepa Mauri, MD, Jose A Fernandez Diaz, MD, Eduardo Pinar, MD, PhD,

Javier Zueco, MD

on behalf of the collaborative IVUS-TRONCO-ICP Spanish study

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled

analysis at patient level of 4 registries. 

Jose M de la Torre Hernandez, MD, PhD, José Antonio Baz Alonso, MD, Joan Antoni Gómez Hospital, MD, PhD, Fernando Alfonso, MD, PhD, Tamara Garcia Camarero,

MD, Federico Gimeno de Carlos, MD, PhD, Gerard Roura Ferrer, MD, Angel Sanchez Recalde, MD, Íñigo Lozano Martínez-Luengas, MD, PhD, Josep Gomez Lara, MD, Felipe Hernandez, MD, María José Pérez-Vizcayno, MD, Angel Cequier Fillat, MD,

PhD, Armando Perez de Prado, MD, Agustín Albarrán, MD, Manuel Jimenez Navarro, MD, PhD, Josepa Mauri, MD, Jose A Fernandez Diaz, MD, Eduardo Pinar, MD, PhD,

Javier Zueco, MD

on behalf of the collaborative IVUS-TRONCO-ICP Spanish study

De la Torre et al. JACC Intv. 2013 (Accepted, in press)De la Torre et al. JACC Intv. 2013 (Accepted, in press)

Registries pooled: Pts with DES in LM: F up:ESTROFA-LM (770 pts in 21 centers) 3 yrs

RENACIMIENTO (596 pts in 30 centers) 1 yr

Bellvitge (189 pts in 1 center) 3 yrs

Valdecilla (200 pts in 1 center) 3 yrs

1.670 patients with PCI with DES in LM

505 patients under IVUS guidance (IVUS group)

Propensity score matched to:

505 patients without the use of IVUS (no-IVUS group)

Registries pooled: Pts with DES in LM: F up:ESTROFA-LM (770 pts in 21 centers) 3 yrs

RENACIMIENTO (596 pts in 30 centers) 1 yr

Bellvitge (189 pts in 1 center) 3 yrs

Valdecilla (200 pts in 1 center) 3 yrs

1.670 patients with PCI with DES in LM

505 patients under IVUS guidance (IVUS group)

Propensity score matched to:

505 patients without the use of IVUS (no-IVUS group)

LM distal subgroupLM distal subgroup

LM distal-2 stents subgroupLM distal-2 stents subgroup

Meta-analysis

0,1 1 10

Odds ratio

RENACIMIENTO (1yr)

ESTROFA-LM (3 yrs)

Valdecilla (3 yrs)

Bellvitge (3 yrs)

Total (fixed effects)

Total (random effects)

IVUS better Angio betterIVUS better Angio better

Overall population

HR 95% CI pIVUS 0.70 0.52 – 0.99 0.04Age 1.03 1.01 – 1.05 0.0001LVEF 0.98 0.97 – 0.99 0.01Diabetes 1.81 1.32 – 2.47 0.0002Distal LM with 2 stents 2.23 1.44 – 3.48 0.0004ACS 1.84 1.30 – 2.60 0.0006 

Subgroup with distal LM disease

HR 95% CI pIVUS 0.54 0.34 – 0.90 0.02Age 1.02 1.004 – 1.05 0.02Diabetes 1.62 1.02 – 2.59 0.04Distal LM with 2 stents 2.86 1.71 – 4.77 0.0001ACS 1.95 1.14 – 3.31 0.01

Predictors of adverse outcome(Cardiac death, MI, TLR)

BifurcacionesOstialesLargas TroncoOTC

Fallo RenalDiabetes FE deprimidaLimitaciones a terapia antiagregante

Cuando hacer IVUS trae cuenta

Angiografia confusa, no clara, flou,.... “La angio no resulta del todo correcta ....”

Lesiones Intermedias

Tronco

Ostiales

Bifurcaciones

“Flou”

Ambiguas

Reestenosis

ICP

Basal Optimizacion ICP

Tomografia de coherencia optica

Placa fibrosa TCFA Placa calcificadaPlaca fibrosa TCFA Placa calcificada

Gonzalo N, J Am Coll Cardiol. 2012 Mar 20;59(12):1080-9Gonzalo N, J Am Coll Cardiol. 2012 Mar 20;59(12):1080-9

Erosión / Disección endotelioDisecciones

Gran diseccion(hematoma)

Trombo RojoTrombo Rojo

Masa que protruye Masa que protruye con sombracon sombra

Trombo BlancoTrombo Blanco

Masa que protruye Masa que protruye sin sombrasin sombra

Sensibilidad: 95%Especificidad: 88%

Diseccionesborde

Diseccionesintrastent

Prolapsotisular

Aposicionincompleta

Mas sensibilidad para hallazgos

STENTS: implante

Gonzalo N, Heart. 2009;95:1913-9Gonzalo N, Heart. 2009;95:1913-9

Kato K et al. ACC 2013Kato K et al. ACC 2013

BIFURCACIONESBIFURCACIONES

Reestenosis de DESMecanismos y opciones de Tx

Reestenosis de DESMecanismos y opciones de Tx

SubexpansionProliferacion intimalFractura stent

SubexpansionProliferacion intimalFractura stent

11

2233

11

22

33

Trombosis a los 7 añosde un DES

Trombosis a los 7 añosde un DES

Neo-aterosclerosisNeo-aterosclerosis

Trombosis de DESMecanismosOpciones de Tx

Trombosis de DESMecanismosOpciones de Tx

Falta de cobertura initmalFalta de cobertura initmal

Trombosis a los 3 mesesde un DES

Trombosis a los 3 mesesde un DES

Estudio DES en el seguimiento

DES: cobertura intimal y aposicion

Tamaño real de la placa o del vaso ?

Carga de placa ? Distribucion de la placa ?Remodelado del vaso ?

?

?

EuroIntervention 2012;8: published online ahead of print October 2012 EuroIntervention 2012;8: published online ahead of print October 2012

Methods

• Consecutive patients undergoing PCI with angiographic plus OCT guidance (OCT group) at three high OCT-volume Italian centers between 2009 and 2011 were included.

• Patients in the OCT group (335 pts) were matched 1:1 with randomly-selected patients undergoing during the same month PCI with angiographic only guidance Angio group (335 pts).

Stent malapposition • > 200 µ• lenght > 600 µ

Edge dissection• > 200 µ• lenght > 600 µ

Under-expansion

In-stent MLA ≥90% of the average reference lumen area or ≥100% of lumen area of the reference segment with the lowest lumen area

Thrombus• > 200 µ• lenght > 600 µ

Absence of residual stenosisadjacent to stent endings (MLA <4.0 mm2)

Distal ProxMSA

MLA <4.0 mm2 MLA <4.0 mm2

Aleatorizados a:IVUS = 35 pacOCT = 35 pac

Aleatorizados a:IVUS = 35 pacOCT = 35 pac

Conclusions: FD-OCT guidance for stent implantation was associated with smaller stent expansion and more frequent significant residual

reference segment stenosis compared with conventional IVUS guidance

Conclusions: FD-OCT guidance for stent implantation was associated with smaller stent expansion and more frequent significant residual

reference segment stenosis compared with conventional IVUS guidance

Aun reconociendo la limitada evidencia con IVUS, aun mas limitada con OCT, ambas mejoran:

- La indicación de la ICP

- Los resultados “mecánicos” inmediatos y muy probablemente los clínicos, especialmente en lesiones de riesgo(Tronco, Bifurcaciones, Reestenosis,...)

Aun reconociendo la limitada evidencia con IVUS, aun mas limitada con OCT, ambas mejoran:

- La indicación de la ICP

- Los resultados “mecánicos” inmediatos y muy probablemente los clínicos, especialmente en lesiones de riesgo(Tronco, Bifurcaciones, Reestenosis,...)

EN CONCLUSIÓN