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Terapia
endovascular:
primera linea de
manejo en CLI?
Dr Luis Morelli
intervencionista periférico
Costa rica
CLI: persiste el reto
!
• Tipo de paciente!
• Compromiso Vascular!
• Altas tasas de reestenosis!
• Severidad del daño tisular
bypass, la mejor estrategia
de tratamiento?
• Morbilidad usualmente subvalorada !
• Eligibilidad!
• Comorbilidades prohibitivas!
• Inadecuado conducto!
• Ausencia de vasos distales meta
ESTUDIO BASIL
• Único estudio randomizado que busca comparar
ambos métodos. !
• Resultados de 1999 a 2004 (más de una década)!
• Pacientes candidatos a ambos en solo un 30%!
• 70% terapia endovascular en un solo segmento,
y la enfermedad multisegmentaria...?
CUAL MÉTODO DE
REVASCULARIZACIÓN?
• Condición general del paciente?!
• Distribución anatómica y características
de la lesión arterial?!
• Grado de calcificación?!
• Inflow, Outflow?!
• Localización de la lesión arterial y tisular!
• Grado de lesión tisular y sepsis?!
• Compromiso de arterias del pie?!
comorbilidades?
the three territories (27).
Figure A7 Typical overlap in vascular disease affecting different territories
(26) Based on REACH data
Norgren L, Circulation 2006; 113:463-654
Legend to figure A7: PAD – peripheral arterial disease
Caracteristicas y distribución
anatomicas de las lesiones
Figure F1 TASC classification of aorto-iliac lesions
Figure F2 TASC classification of femoral popliteal lesions
Legend to figure F1: CIA – common iliac artery; EIA – external iliac artery; CFA –
Legend to figure F2: CFA – common femoral artery; SFA – superficial femoral
Arterial Progressive Involvement
74% all cases !
1%
8%
14%
36%
Graziani l. et al. Eur J Vasc Endovasc Surg 2007;33,453-460
11%
27%
1%
Limitaciones en Clasificaciones
actuales TASC...
Graziani L, Piaggesi A. Catheter and Cardiovasc Interv 2010;75: 433-443
Limitaciones en Clasificaciones
actuales TASC...
1.
No considerar la enfermedad multisegmentaria
2.
Exclusión del territorio BK en sus recomendaciones
3.
Además recomendar cx convencional en casos complejos se basa en experiencia
desactualizada.
Graziani L, Piaggesi A. Catheter and Cardiovasc Interv 2010;75: 433-443
Grado de calcificación
VIA ARTERIA PLANTAR
Compromiso
inflow-outflow
Ilio-femoro-popliteo-tibial,
Bypass?
stent
iliac
o
Enf tibial
difusa
Oclusiones !
fem-pop
Endovascular?
PTA+Stenting Iliaca externa, femoro-popliteo y tibial posterior
Localización del Daño tisular y
arterial??
angiosome guide
Peroneal Artery Ang
Tibial
Anterior Tibial Angiosome
Posterior Tibial Angiosomes
Peronea
Anterior
Tibial PosteriorPeroneal Artery Angiosome
Posterior Tibial Angiosomes
QUE DEBERIAMOS
REVASCULARIZAR?
• El mejor vaso meta: bypass!
• Revascularización directa:
compartimentalización por angiosomas!
• Lide et al : direct vs indirect revascularization:!
✴ Amputation free survival 49% vs 29%
(P=0.0002)!
✴ Freedom from MAE limbs 51% vs 28%
(P=0.008)!
✴ Freedom Major Amputation 82% vs 68%%
J Vasc Surg 2011; 18:753-61
(P=0.01)
INVOLUCRO DE
LAS ARTERIAS
DEL PIE
REVASCULARIZACIÒN
DEL ARCO DEL PIE
REVASCULARIZACIÒN
DEL ARCO DEL PIE
REVASCULARIZACIÒN
DEL ARCO DEL PIE
AUSENCIA DE CONDUCTO
VENOSO ADECUADO
Protesis de PTFEe Heparin Bonded
Muñon Bypass
PTA previa
DEB +BMS
RESULTADOS
soporte en la literatura
• Lo primero ha declarar es que no existe
estudios que comparen adecuadamente
ambos procedimiento!
• Debido a la heterogenicidad de
población, tratamientos, características
de las lesiones, objetivos buscados.
angioplastia con balón
• Meta-analysis 30 estudios con un total
de 2653 extremidades con lesiones BTK!
• Ofreció un “endovascular first
approach” en comparación con bypass
popliteo-distal
Romiti et al. J Vasc Surg 2011; 53:1007-13
data PTA
Author
Romiti et al!
J Vasc 2008;47:975-81
Arvela et al!
Br J Surg 2011;98:518-26
Haider et al !
J Vasc Surg
2006;43:504-12
# patients
2653
Technical
Success
89%
Primary
Patency
48.6% (36m)
584 lesions in
>80 years old
180 (ATK/BTK
vs Bypass)
75% vs 69%ATK !
60% vs 53%BTK!
2y!
Secondary!
Patency
82.3% (36 m)
Limb salvage
Comments
82.4% (36m)
Bypass PP 72%
(36m) same LS
results
85.4% vs 78.7%
(2y)
Angioplasty:
better 2y
survival rates
57.7vs52.3%
No significant
90% vs 87%!
better outcomes
76%vs 57% (2y)
for surgery
Tab. 4. Results of endovascular treatment of combined BK and femoropopliteal lesions in
subjects with CLI
Author
Technical
Lesions
success %
Faglia [14]
993 (1,191)
83
Dorros [17]
270
Lofberg [18]
Soder [19]
Brillu [20]
Limb salvage
Primary
%
Patency
0.1
88 (5yrs)
-
91
0.4
91 (5yrs)
-
94
88
2.4
72 (3yrs)
-
72
74
-
80 (18mo)
48%, (18mo)
37
94.5
-
87 (2yrs)
-
Fo
Patients/
Mortality %
ev
rR
37/57
-
2.0
98 (6mo)
61-83%, (6mo)
Staffa [22]
18
-
-
-
78%, (6mo)
Matsagas [23]
67
88
4.0
98 (3yrs)
52%, (2yrs)
Balmer [24]
66
-
-
94 (12mo)
44%, (1yr)
Ferraresi [25]
107
98
-
93 (3yrs)
42%, (1yr)
iew
Rand [21]
Graziani L, Piaggesi A. (2010). Indications and clinical outcomes for below knee endovascular therapy: review article.
Catheterization and Cardiovascular Interventions 75(3):433-43
Tab. 4. Results of endovascular treatment of combined BK and femoropopliteal lesions in
subjects with CLI
Author
Faglia [14]
Patients/
Technical
Lesions
success %
993 (1,191)
83
Mortality %
0.1
Limb salvage
Primary
%
Patency
88 (5yrs)
-
Technical
Success
% Limb
Salvage
Dorros [17]
270% Mortality
91
0.4
91 (5yrs)
Primary
Patency
94
88
2.4
72 (3yrs)
-
Soder [19]
72
74
-
80 (18mo)
48%, (18mo)
37
94.5
-
87 (2yrs)
-
Brillu [20]
Fo
Lofberg [18]
ev
rR
Rand [21]
37/57
-
2.0
98 (6mo)
61-83%, (6mo)
Staffa [22]
18
-
-
-
78%, (6mo)
<2%
88
4.0
98 (3yrs)
55,6%
-
-
94 (12mo)
44%, (1yr)
98
-
93 (3yrs)
42%, (1yr)
88%
67
Balmer [24]
66
Ferraresi [25]
107
89%
iew
Matsagas [23]
52%, (2yrs)
Graziani L, Piaggesi A. (2010). Indications and clinical outcomes for below knee endovascular therapy: review article.
Catheterization and Cardiovascular Interventions 75(3):433-43
data BMS IN BTK
Author
Abularrage et
al!
J Vasc Surg
2011;53:1007-13
Bosiers et al!
J Cardiovasc
Surg2007;48:455-61
# patients
Technical Success
Primary
Patency
Secondary!
Patency
Limb salvage
Comments
920 (1075
procedures)
89%
30% tibial (5y)
81% (5y)
75% (5y)
5y survival tibial
group 47%
95.9% (1y)
Differences
proximal and
distal BTK proc
for limb salvage
100% vs 81.8%
90.8% (2y)
No differences
between proximal
and distal
96% (1y)
Heterogeneity
affected the
outcome
51 (58 BTK
procedures)
Xpert stent
Bosiers et al!
Update
102 (134
Xpert stens)
Biondi-Zoccai
et al !
640 tibial
secondary
stenting
J Endovasc
Ther2009;16:251-60
76.3% (1y)
angiographic
54.4% (2y US)
79% (1y)!
data BMS IN BTK
Author
# patients
Technical Success
PRIMARY PATENCY
Abularrage et
al!
J Vasc Surg
2011;53:1007-13
920 (1075
procedures)
51 (58 BTK
procedures)
Xpert stent
77%
Bosiers et al!
J Cardiovasc
Surg2007;48:455-61
Bosiers et al!
Update
102 (134
Xpert stens)
89%
Primary
Patency
Secondary!
Patency
Limb salvage
Comments
SECONDARY PATENCY LIMB SALVAGE
30% tibial (5y)
81% (5y)
81%
76.3% (1y)
angiographic
54.4% (2y US)
75% (5y)
5y survival tibial
group 47%
95.9% (1y)
Differences
proximal and
distal BTK proc
for limb salvage
100% vs 81.8%
90.8% (2y)
No differences
between proximal
and distal
95%
MEAN 1 YEAR RESULTS
Biondi-Zoccai
et al !
J Endovasc
Ther2009;16:251-60
640 tibial
secondary
stenting
79% (1y)!
96% (1y)
Heterogeneity
affected the
outcome
data DES in BTK
Author
Siablis et al!
J Vasc Interv
Radiol2007;
18:1351-61
Scheinert et
al!
Eurointervention
2006;2:169-74!
Feiring et al!
PaRADISE!
J Am Coll Cardiol
2010;55:1580
ACHILLES
study!
# patients
Primary
Patency
29 (sirolimus stents) vs 29
BMS in BTK
86.4% vs
40.5%(1y)
60 with BTK maximal
lenght 30mm
76.3% (1y)
angiographic
Limb
salvage
Comments
36.7% vs 78.6%
(1y)
75% (5y)
Mean Length 14
mm!
P<0.001
0% vs 56.6% 6m
angiographic
95.9%
(1y)
P<0.001
94% (3y)
Survival rate and
amputation free
survival 71% and
68% respectively
Binary Restenosis
118
200 ( maximal lenght
120mm)!
113 Cypher vs 115 PTA
80.6% vs
YUKON-BTK 82 Sirulimus polymer free
55.6% (1y) P=
trial
vs 79 BMS
0.004
DESTINY!
J Vasc Surg
Secondary
Patency
140 Compared Xcience V
85.2% vs
to Multilink Vision
54.4%
Maximal lenght 40mm P=0.0001 12 m
18.7 mm vs 45.5
mm (P<0.001) 1y
71.4% vs
91.9% (1y)
P=0.005
CLI and
Claudicants
data DES in BTK
Author
Siablis et al!
J Vasc Interv
Radiol2007;
18:1351-61
Scheinert et
al!
Eurointervention
2006;2:169-74!
# patients
Primary
Patency
29 (sirolimus stents) vs 29
BMS in BTK
86.4% vs
40.5%(1y)
60 with BTK maximal
lenght 30mm
76.3% (1y)
angiographic
Secondary
Patency
Limb
salvage
Comments
36.7% vs 78.6%
(1y)
75% (5y)
Mean Length 14
mm!
P<0.001
0% vs 56.6% 6m
angiographic
95.9%
(1y)
P<0.001
Binary Restenosis
Mean Primary Patency 82,2% vs
50,1% for BMS
Feiring et al!
PaRADISE!
J Am Coll Cardiol
2010;55:1580
ACHILLES
study!
118
200 ( maximal lenght
120mm)!
113 Cypher vs 115 PTA
80.6% vs
YUKON-BTK 82 Sirulimus polymer free
55.6% (1y) P=
trial
vs 79 BMS
0.004
DESTINY!
J Vasc Surg
94% (3y)
140 Compared Xcience V
85.2% vs
to Multilink Vision
54.4%
Maximal lenght 40mm P=0.0001 12 m
Survival rate and
amputation free
survival 71% and
68% respectively
18.7 mm vs 45.5
mm (P<0.001) 1y
71.4% vs
91.9% (1y)
P=0.005
CLI and
Claudicants
FINISHED CLINICAL STUDIES ON DEB
STUDY
Thunder
DEVICE
LESIONS
TREATED
Paccocath (A1), PTA
De novo
contrast(A2),
femoropoplitea
PTA(A3)
PATIENTS
RESULTS
154
LLL a 6 m: A1 0.4mm, A2 2.2mm n’ A3 1.7mm!
TLR a 6 m:A1 4%, A2 29% n’ A3 37%
Fempac
Pilot
Paccocath (A1),
PTA(A2)
De novo
femoropoplitea
87
LLL a 6 m: A1 0.3mm, A2 0.8mm BR a 18m: A1
7% y A2 17%!
TLR a 18 m:A1 17%, A2 40%
In.Pact
Admiral
Italian
Registry
In.Pact Admiral
De novo
femoropoplitea
105
Patencia Primaria a 12 meses 84% n TLR 9%
PACIFIER
In.Pact Pacific (A1)
vs PTA (A2)
De novo
femoropoplitea
91
LLL a 6 m: A1 0.01mm, A2 0.65mm !
BR a 6 m: A1 9% y A2 32%!
TLR a 6 m:A1 7%, A2 26%
Levanti I
Moxy DEB (A1) vs
PTA (A2)
De novo
femoropoplitea
75
LLL a 6 m: A1 0.46mm, A2 1.09mm!
TLR a 6 m:A1 49%, A2 72%
Schmidt et
al
In.Pact Amphirion
BTK
104
BR a 3 m: 27%!
TLR a 12 m: 17%!
Limb Salvaje a 12 m: 96%
DEBATEBTK
In.Pact
Amphirion(A1)/
Amphirion (A2)
BTK
120
BR a 12 m: A1 29%, A2 72%
FINISHED CLINICAL STUDIES ON DEB
STUDY
Thunder
Fempac
Pilot
DEVICE
LESIONS
TREATED
Paccocath (A1), PTA
De novo
contrast(A2),
femoropoplitea
PTA(A3)
Paccocath (A1),
PTA(A2)
De novo
femoropoplitea
PATIENTS
RESULTS
154
LLL a 6 m: A1 0.4mm, A2 2.2mm n’ A3 1.7mm!
TLR a 6 m:A1 4%, A2 29% n’ A3 37%
87
LLL a 6 m: A1 0.3mm, A2 0.8mm BR a 18m: A1
7% y A2 17%!
TLR a 18 m:A1 17%, A2 40%
Statistical Improvement on LLL,
TLR and BR at 12 month FU
In.Pact
Admiral
Italian
Registry
In.Pact Admiral
De novo
femoropoplitea
PACIFIER
In.Pact Pacific (A1)
vs PTA (A2)
Levanti I
Moxy DEB (A1) vs
PTA (A2)
105
Patencia Primaria a 12 meses 84% n TLR 9%
De novo
femoropoplitea
91
LLL a 6 m: A1 0.01mm, A2 0.65mm !
BR a 6 m: A1 9% y A2 32%!
TLR a 6 m:A1 7%, A2 26%
De novo
femoropoplitea
75
LLL a 6 m: A1 0.46mm, A2 1.09mm!
TLR a 6 m:A1 49%, A2 72%
Schmidt et
al
In.Pact Amphirion
BTK
104
BR a 3 m: 27%!
TLR a 12 m: 17%!
Limb Salvaje a 12 m: 96%
DEBATEBTK
In.Pact
Amphirion(A1)/
Amphirion (A2)
BTK
120
BR a 12 m: A1 29%, A2 72%
more distal vessels. Anatomic factors that affect the patency include severity of
disease in run off arteries, length of the stenosis/occlusion and the number of
lesions treated. Clinical variables impacting the outcome also include diabetes,
renal failure, smoking and the severity of ischemia.
Recommendation 35: Choosing between techniques with equivalent short- and
long-term clinical outcomes
•
In a situation where endovascular revascularization and open repair/bypass
of a specific lesion causing symptoms of peripheral arterial disease give
equivalent short-term and long-term symptomatic improvement,
endovascular techniques should be used first [B]
Norgren L, Circulation 2006; 113:463-654
F1.1 Classification of lesions
While the specific lesions stratified in the following TASC classification schemes
more distal vessels. Anatomic factors that affect the patency include severity of
disease in run off arteries, length of the stenosis/occlusion and the number of
lesions treated. Clinical variables impacting the outcome also include diabetes,
renal failure, smoking and the severity of ischemia.
Recommendation 35: Choosing between techniques with equivalent short- and
long-term clinical outcomes
•
In a situation where endovascular revascularization and open repair/bypass
of a specific lesion causing symptoms of peripheral arterial disease give
equivalent short-term and long-term symptomatic improvement,
endovascular techniques should be used first [B]
Norgren L, Circulation 2006; 113:463-654
F1.1 Classification of lesions
While the specific lesions stratified in the following TASC classification schemes
Conclusiones
Conclusiones
• Terapia endovascular ha probado ser:!
• Fácil reproductibilidad de resultados en
centros de alto volumen de pacientes!
• Amplia indicación en pacientes de alto
riesgo quirúrgico!
• Cumple desempeño clínico y funcional,
parcialmente con desempeño técnico!
Conclusiones
• Terapia endovascular ha probado ser:!
• Fácil reproductibilidad de resultados en
centros de alto volumen de pacientes!
• Amplia indicación en pacientes de alto
riesgo quirúrgico!
• Cumple desempeño clínico y funcional,
parcialmente con desempeño técnico!
Durabilidad
Conclusiones
• Nuevos avances tecnológicos y farmacológicos
han permitido ofrecer la terapia endovascular
como el tratamiento de elección en pts con CLI.!
• Diseñado para una población muy enferma y
añosa!
• Desde el punto de vista técnico ha sobrepasado
la cirugía convencional con la excepción en la
durabilidad.
Conclusiones
Conclusiones
• Del punto de vista clínico con
resultados similares o superiores,
incluso desde el punto de vista
durabilidad: “Clinical Patency”!
• Desde el punto de vista del paciente la
aceptabilidad ha sido mucho mejor.
Contact: [email protected]
• Muchas Gracias
Contact: [email protected]