hemodinamia y cardiología intervencionista sanatorio delta ... · cto classification, j am coll...
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XXXII Jornadas SOLACI, Santa Cruz de la Sierra, Bolivia, 11° Región Cono Sur, Abril, 2017
Dr. Rubén Piraino
Hemodinamia y Cardiología Intervencionista
Sanatorio Delta – Sanatorio Rosendo García
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Visión del Clínico
Visión del Cirujano
Visión del Intervencionista
Trata Lesiones Culpables y No Culpables
Trata Lesiones Culpables y Algunas
No Culpables
Trata Lesiones Culpables
Paciente Estable con Enfermedad Coronaria de Múltiples Vasos
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Pte 1
Pte 1 Pte 2
Pte 2 Cx 70-90%
DA 70-90%
CD 2 70-90%
CD 3 70-90%
TCI 99%
Cx 100%
DA 99%
CD 100%
Existen “enfermedad de 3 vasos” y “enfermedad de 3 vasos”
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Score de Syntax
BARI classification of coronary segments Leaman score, Circ 1981;63:285-299 Lesions classification ACC/AHA , Circ 2001;103:3019-3041 Bifurcation classification, CCI 2000;49:274-283 CTO classification, J Am Coll Cardiol 1997;30:649-656
No. &
Location
of lesion Left
Main
Tortuosity
3 Vessel Thrombus
Bifurcation CTO
Calcification
SYNTAX
SCORE
Dominance
3 Categorias de Riesgo:
BAJO
INTERMEDIO
ALTO
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Pte 1
Pte 1 Pte 2
Pte 2
SYNTAX SCORE 21 SYNTAX SCORE 52
Cx 70-90%
DA 70-90%
CD 2 70-90%
CD 3 70-90%
TCI 99%
Cx 100%
DA 99%
CD 100%
Existen “enfermedad de 3 vasos” y “enfermedad de 3 vasos”
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CORRECAMINOS “BY PASS”
COYOTE “STENT”
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COYOTE “STENT”
CORRECAMINOS “BY PASS”
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71% enrolled (N=3,075)
All Pts with de novo 3VD and/or LM disease (N=4,337)
Treatment preference (9.4%)
Referring MD or pts. refused informed consent (7.0%)
Inclusion/exclusion (4.7%)
Withdrew before consent (4.3%)
Other (1.8%)
Medical treatment (1.2%) TAXUS n=903
PCI n=198
CABG n=1077
CABG n=897
no f/u n=428
5yr f/u n=649
PCI all captured w/
follow up
CABG 2500
750 w/ f/u vs
Total enrollment N=3075
Stratification: LM and Diabetes
Two Registry Arms
Randomized Arms n=1800
Two Registry Arms N=1275
Randomized Arms N=1800
Heart Team (surgeon & interventionalist)
PCI N=198
CABG N=1077
Amenable for only one treatment approach
TAXUS*
N=903 CABG
N=897 vs
Amenable for both treatment options
Stratification: LM and Diabetes
LM 33.7%
3VD 66.3%
LM 34.6%
3VD 65.4%
DM 28.5%
Non DM 71.5%
NonDM 71.8%
DM 28.2%
23 US Sites 62 EU Sites +
SYNTAX Trial
SYNTAX trial. Lancet 2013;381(9867):629 – 638.
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CABG PCI P value
Death 10.1% 8.9% 0.64
CVA 4.0% 1.8% 0.11
MI 4.2% 7.8% 0.11
Death, CVA or
MI 14.9% 16.1% 0.81
Revasc. 16.9% 23.0% 0.06
P=0.43
Overall
MACCE a 5 años SYNTAX Score Tercile Low Scores (0-22)
32.1%
28.6%
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%)
0 12 24
50
0
25
48 36 60
SYNTAX trial. Lancet 2013;381(9867):629 – 638.
TAXUS (N=299)
CABG (N=275)
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CABG PCI P value
Death 12.7% 13.8% 0.68
CVA 3.6% 2.0% 0.25
MI 3.6% 11.2% <0.001
Death, CVA or
MI 18.0% 20.7% 0.42
Revasc. 12.7% 24.1% <0.001
Overall
MACCE a 5 años SYNTAX Score Tercile Intermediate Scores (23-32)
36.0%
25.8%
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%)
0 12 24
50
0
25
48 36 60
P=0.008
TAXUS (N=210)
CABG (N=300)
SYNTAX trial. Lancet 2013;381(9867):629 – 638.
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Overall
TAXUS (N=290)
CABG (N=315)
MACCE a 5 años SYNTAX Score Tercile High Scores (33)
P<0.001
44.0%
26.8%
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
CABG PCI P value
Death 11.4% 19.2% 0.005
CVA 3.7% 3.5% 0.80
MI 3.9% 10.1% 0.004
Death, CVA or
MI 17.1% 26.1% 0.007
Revasc. 12.1% 30.9% <0.001 Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%)
0 12 24
50
0
25
48 36 60
SYNTAX trial. Lancet 2013;381(9867):629 – 638.
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37,3
9,7 9
2,4
26,9
3,8 5,3 3,7
MACE IAM MUERTE STROKE
Seguimiento 5 años
DES CABG
SYNTAX Trial: Revascularizacion en Enfermedad Múltiples Vasos
P:Sig
P:Sig
P:Sig
P:Sig
SYNTAX trial. Lancet 2013;381(9867):629 – 638.
STENT FARMACOLOGICO de 1ra GENERACION
*TAXUS Express
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MV-Stenting Con DES
CIRUGIA LIMA
recomendada
Randomiza 1:1
Elegibilidad: Pacientes DM con MV-CAD elegibles para stent o cirugía
Angiográficamente: Enfermedad Coronaria confirmada, con lesiones severas (> 70%) en
al menos dos grandes vasos epicárdicos
Excluir: Pacientes con STEMI aguda
Punto Final Primario: Muerte, Infarto, ACV Seguimiento: 7 años (min 2 años, media 3.8 años)
Farkouh et al. N Engl J Med 2012;367:2375-84
STENT FARMACOLOGICOS DE 1ra GENERACION
FREEDOM: Revascularizacion en Diabeticos con EMV
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20,6
13,9
16,3
2,5
18,7
6
10,9
5,2
MACE IAM MUERTE STROKE
Seguimiento 5 años
DES CABG
FREEDOM: Revascularizacion en Diabeticos con EMV
P:Sig
P:Sig
P:Sig
P:Sig
Farkouh et al. N Engl J Med 2012;367:2375-84
STENT FARMACOLOGICO de 1ra GENERACION
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Recomendacion para el tipo de Revascularizacon (CABG or PCI) en pacentes con Enfermedad Coronaria Estable con Anatomia Compatible para ambos procedimientos
2014 ESC/EACTS Guias de Revascularizacion Miocardica
Extensión enfermedad Coronaria CIRUGIA ANGIOPLASTIA
CLASE NIVEL CLASE NIVEL
1 o 2 Vasos sin DA proximal IIb C I C
1 o 2 Vasos con DA proximal I A-B I A-C
TCI Syntax <22 I B I B
TCI Syntax 22-32 I B IIa B
TCI Syntax >32 I B III B
3 Vasos Syntax <22 I A I B
3 Vasos Syntax 22-32 I A III B
3 Vasos Syntax >32 I A III B
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Cual es el estado actual entre la Cirugia vs. Angioplastia?
• La CIRUGÍA disminuye la necesidad de Nuevas REVASCULARIZACIONES
• La CIRUGÍA disminuye el INFARTO a
largo Plazo Protege futuras rupturas de placa en el segmento tratado con el by pass. • La CIRUGÍA disminuye la MORTALIDAD a
largo Plazo
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alguna vez me
gustaría que gane el coyote!
…pero los tiempos cambian
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Nueva Generacion Stents Farmacologicos Cambio de Espesor
1ra Generacion DES Nueva Generacion DES
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1ra Generacion DES Nueva Generacion DES
….Si …………….….No …………….….No
No.. Si …………….. Si ………………….
Nueva Generacion Stents Farmacologicos Cambio de Polimero
1ra Generacion DES Nueva Generacion DES
Cubierta Uniforme Delaminacion
Grumos
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Endotelizacion completa A los 14 días
Endotelizacion Incompleta
Nueva Generacion Stents Farmacologicos Cambio de Endotelizacion
1ra Generacion DES Nueva Generacion DES
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STRUTS MORPHOLOGY AND SHEAR STRESS It can be seen that the meshes of greater height and with rectangular morphology produce larger areas of low shear (blue and green color)
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SHEAR STRESS AND THROMBOSIS
The morphology of the strut that produces a major obstacle to coronary flow produces zones of high shear stress in the upper part of the strut which induces the release of ADP which is an important inducer of platelet aggregation. In addition, immediately distal to the strut a large recirculation zone is formed and under shear stress inducing the formation of aggregators (vWF, fibrinogen, prothrombin) and retards endothelialization by decreasing levels of NO, PGI 2 and tPA
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SHEAR STRESS AND THROMBOSIS
The smaller size and the more adequate morphology of the strut favor the endothelialization and the inhibition of the antiaggregation
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REVASCULARIZACION
Bangalore et al. BMJ 2013;347
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MORTALIDAD
Bangalore et al. BMJ 2013;347
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INFARTO
Bangalore et al. BMJ 2013;347
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7,25
1,87
3,1
0,72
3,1
1,13
2,86
0,97
REVASC IAM MUERTE STROKE
% EVENTOS/año
Seguimiento 3 años
EES CABG
EES vs. Cirugia: Revascularizacion en Enfermedad Múltiples Vasos
Bangalore. NEJM 372;13. Marzo 2015
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MORTALIDAD: menor diferencia entre Angioplastia y Cirugía: NY State Registry
N Engl J Med 2005; 352: 2174-83
J Am Coll Cardiol 1999;33:63- 72.
N Engl J Med 2008;358:331-41. N Engl J med 2015; 372:1213-22
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REINTERVENCIONES: disminución de la Tasa con Angioplastia: NY State Registry
N Engl J Med 2005; 352: 2174-83 J Am Coll Cardiol 1999;33:63- 72.
N Engl J Med 2008;358:331-41. N Engl J med 2015; 372:1213-22
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Randomized trials in myocardial revascularization therapy
over the past five decades.
Authors/Task Force members et al. Eur Heart J
2014;35:2541-2619
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EXCEL
EES vs. CABG
EXCEL Trial Investigators. NEJM October 31, 2016
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R
Follow-up: 1 month, 6 months, 1 year, annually through 5 years
Primary endpoint: Measured at a median 3-yr FU, minimum 2-yr FU
Study Design
2900 pts with unprotected left main disease
SYNTAX score ≤32
Consensus agreement of eligibility and equipoise by heart team
Yes
(N=1900)
No
(N=1000)
Enrollment
registry
PCI (Xience EES)(N=950)
CABG(N=950)
Stratified by diabetes, SYNTAX score and center
2900 ptes. con Enf. TCI no Protegido
Diseño del Estudio
SYNTAX SCORE < 32 Acuerdo por Consenso del Heart Team de Elegibilidad para PCI o CABG
SGTO: 1 mes, 6 meses, 1 año, anualmente hasta 5 años PUNTO FINAL 1rio: Muerte, Infarto, Stroke medidos a una media de 3 anios
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Pte de SYNTAX
Pte de SYNTAX
Cx 70-90%
DA 70-90%
CD 2 70-90%
CD 3 70-90%
EXCEL: Enf. TCI no Protegido Syntax Score < 32
SYNTAX SCORE 21 SYNTAX SCORE 31
Pte de EXCEL
Pte de EXCEL
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17,3
31 34
17,2 17,8
31,2 31,5
19,4
0 vaso 1 vaso 2 vasos 3 vasos
EES CIRUGIA
EXCEL: Enf. TCI no Protegido Nro. Vasos Enfermos (NO TCI)
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CIRUGÍA Mayor riesgo de eventos a corto Plazo
Similar riesgo de eventos a Largo Plazo
EXCEL Trial Investigators. NEJM October 31, 2016
39%
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EXCEL Trial Investigators. NEJM October 31, 2016
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EXCEL Trial Investigators. NEJM October 31, 2016
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TCI no Protegido, Syntax bajo o intermedio (<22, 22-32)
EES=Cirugía : Muerte, infarto, Stroke a 3 años EES menor EVENTOS a 30 días comparado con Cirugía
La Angioplastia: modalidad de revascularización
aceptable o preferida para pacientes seleccionados con TCI no Protegido.
CONCLUSIONES
EXCEL Trial Investigators. NEJM October 31, 2016
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El “EXCEL”
Que cambio entre
nosotros?
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Revascularizacion en TCI y Múltiples Vasos Syntax Score <32
SYNTAX Left Main Score <32 – 5y FU
Muerte, Stroke, Infarto + Revascularizacion
EXCEL Left Main Score <32 – 3y FU
Muerte, Stroke, Infarto
Morice MC et al. Circulation. 2014;129:2388-94 . EXCEL Trial Investigators. NEJM October 31, 2016
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SYNTAX (TCI + MV) EXCEL (TCI + MV)
14,8
6,1 7,9
1,4
19,8
3,8
15,1
3,9
MACE IAM MUERTE STROKE
Seguimiento 5 años
PES CABG
15,4
8
3,7 2,3
14,7
8,3
3,4 2,9
MACE IAM MUERTE STROKE
Seguimiento 3 años
EES CABG
XIENCE V *TAXUS Express
Morice MC et al. Circulation. 2014;129:2388-94 . EXCEL Trial Investigators. NEJM October 31, 2016
Revascularizacion en TCI y Múltiples Vasos Syntax Score <32
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SYNTAX (TCI + MV) EXCEL (TCI + MV)
Morice MC et al. Circulation. 2014;129:2388-94 . EXCEL Trial Investigators. NEJM October 31, 2016
Revascularizacion en TCI y Múltiples Vasos Syntax Score <32
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Lesión de Tronco no Protegido Características Población Meta-Análisis (Boudriot, PRECOMBAT, SYNTAX, NOBLE, EXCEL)
28 33
61
2,6
16
24
33 34
60
2,8
18 24
Diabetes AnginaInestable
Fey RiesgoQuirurgico
LT solo Syntax
Angioplastia Cirugia
Nitesh Nerlekar et al. Circ Cardiovasc Interv.
2016;9:e004729
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Risk estimates for primary safety end point for percutaneous
coronary intervention vs coronary artery bypass grafting (CABG).
Nitesh Nerlekar et al. Circ Cardiovasc Interv.
2016;9:e004729
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Risk estimates for secondary effectiveness end point for percutaneous
coronary intervention vs coronary artery bypass grafting (CABG).
Nitesh Nerlekar et al. Circ Cardiovasc Interv.
2016;9:e004729
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Risk estimates for individual clinical outcomes for percutaneous
Coronary intervention vs coronary artery bypass grafting (CABG).
Nitesh Nerlekar et al. Circ Cardiovasc Interv.
2016;9:e004729
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Lesión de Tronco no Protegido Tasa de Eventos Clínicos Meta-Análisis (Boudriot, PRECOMBAT, SYNTAX, NOBLE, EXCEL)
13,7
23,3
6 7,4
2
14,2 14,1
18,2
4,8 7
2,2
8,3
Angioplastia Cirugia
Nitesh Nerlekar et al. Circ Cardiovasc Interv.
2016;9:e004729
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1ra Generacion Stent
Farmacológico
Eventos Relacionados con
el Stent
Reestenosis
Trombosis
Neoaterosclerosis
INFARTO
MUERTE
Cirugía Mejor que Angioplastia con Stent
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Nueva Generacion Stent
Farmacológico
Sin Eventos Relacionados con
el Stent
Menor Reestenosis,
Trombosis y
Neoaterosclerosis
MENOR
INFARTO
MUERTE
Angioplastia con Stent IGUAL que Cirugía
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CONCLUSIONES
• EFICACIA Y LA SEGURIDAD Superioridad consistente de la nueva generación de DES
• La decisión sobre: CIRUGÍA vs. ANGIOPLASTIA debería
basarse en: Capacidad para revascularizar completamente Pesar el riesgo a corto plazo de muerte y accidente
cerebrovascular con CABG con el beneficio a largo plazo de reducir el riesgo de revascularización repetida
Preferencia del paciente
• El beneficio de mortalidad de la CRM durante la segunda generación de DES sigue sin probarse
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Como elegir sabiamente entre Angioplastia o Cirugía
CIRUGÍA: con mayores eventos adversos dentro de los 30 días
ANGIOPLASTIA: con mayores REVASCULARIZACIONES largo plazo
La preferencia de los pacientes importa
CORRECAMINOS “BY PASS”
COYOTE “STENT”
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Editorial EXCEL Trial por Dr. Braunwald
"El mensaje del estudio EXCEL es que la mayoría de los pacientes con enfermedad de Tronco de coronaria izquierda no protegida, que era muy grave, acortaba la vida, e Incapacitante a principios de mi vida profesional, ahora se puede manejar igualmente bien por medio de dos estrategias de revascularización si se lleva a cabo por expertos y equipos experimentados ".
This editorial was published on October 31, 2016, at NEJM.org.
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BARI 2D: Revascularizacion en Diabeticos con EMV
16 14
15,8
21,9
ANGIOPLASTIA TMO CIRUGIA TMO
MORTALIDAD SEGUN TRATMIENTO
November 17, 2009, 10.1161/CIRCULATIONAHA.109
NS S
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BEST vs. Bangalore: Revascularizacion en Enfermedad Múltiples Vasos
Bangalore. NEJM 372;13. Marzo 2015
BEST. Park. NEJM . Marzo 2015
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SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 13
CABG PCI P value
Death 10.1% 8.9% 0.64
CVA 4.0% 1.8% 0.11
MI 4.2% 7.8% 0.11
Death, CVA or
MI 14.9% 16.1% 0.81
Revasc. 16.9% 23.0% 0.06
P=0.43
Overall TAXUS (N=299)
CABG (N=275)
MACCE to 5 Years by SYNTAX Score Tercile Low Scores (0-22)
32.1%
28.6%
Core lab-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Months Since Allocation
Cum
ula
tive E
vent
Rate
(%
)
0 12 24
50
0
25
48 36 60
SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 14
CABG PCI P value
Death 12.7% 13.8% 0.68
CVA 3.6% 2.0% 0.25
MI 3.6% 11.2% <0.001
Death, CVA or
MI 18.0% 20.7% 0.42
Revasc. 12.7% 24.1% <0.001
Overall TAXUS (N=310)
CABG (N=300)
MACCE to 5 Years by SYNTAX Score Tercile Intermediate Scores (23-32)
36.0%
25.8%
Core lab-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Months Since Allocation
Cum
ula
tive E
vent
Rate
(%
)
0 12 24
50
0
25
48 36 60
P=0.008
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Study Patient Demographics, Angiographic Characteristics, and Procedural Characteristics