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Tratamiento endovascular eje fémoro-poplíteo: actualización de estudios y “new data”
Dr Costantini Ricardo – Cardioangiología Intervencionista
Jornadas Intervencionistas
Arteriales y Venosas del Hospital Austral
(JAVA) 2019
5 Yr Mortality – Enfermedad Vascular Periférica
Para aquellos que han sufrido amputación
Varu VN; Hogg ME; Kibbe MR. Critical limb ischemia J Vasc Surg 2010; 51: 230 - 241
Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg. 2000;31(1 pt 2):S1–S296
Weighted mean prevalence of intermittent claudication in large population-based studies.
Prevalencia de enfermedad vascular periférica:4% > 40 años
15% - 20% > 65 añosCirculation 2006; 113: 463 - TASC II – J Vasc Surg 2007
N Engl J Med 2001 Vol 344, 21: 1608
Circulation. 2007;116:2203-2215
Consensus Definitions From Peripheral Academic Research Consortium (PARC) J Am Coll Cardiol 2015;65:931–41)
Mortalidad en Enfermedad Vascular Periférica
Disminución del riesgo de infarto, stroke y muerte CV
Mejoría de los síntomas, calidad de vida y prevención de amputación
Discontinuación habito tabáquico Discontinuación habito tabáquico
Programa de caminata / ejercicios Programa de caminata / ejercicios
Control de presión arterial Cilostazol
Estatinas: dosis altas Cuidado adecuado de pies: cremas, tratamiento y prevención de micosis, prevención de puntos de presión anormal con ortesis, cuidados de uñas.
Tratamiento antiplaquetario Revascularización
Farzin Fakhry; Sandra Spronk et alJAMA. 2015;314(18):1936-1944
(ERASE Trial)Endovascular Revascularization And Supervised Exercise
212 patients: supervised exercise (n = 106) vs PTA plus supervised exercise (n = 106)
The primary outcome was maximum walking distance at12 months assessed during a
graded treadmill test (maximum duration,
30 minutes).
Farzin Fakhry; Sandra Spronk et alJAMA. 2015;314(18):1936-1944
(ERASE Trial)Endovascular Revascularization And Supervised Exercise
212 patients: supervised exercise (n = 106) vs PTA plus supervised exercise (n = 106)
Piotr Sobieszczyk and Andrew Eisenhauer - Circulation. 2013;128:749-757
POBA
DrugsElutingsStents
AtherectomyStents
Drugs-Coated
Balloons
(BASIL trial): Bypass versus PTA in severe ischaemia of the leg
Lancet 2005; 366: 1925–34
Since 1999 - finished 2004452 patients underwent randomisation at one of 27 UK hospitals
Primary endpoint (amputation-free survival) at 1 year was 68% and at 3 years was 57% for those assigned to surgery first;
Survival at 1 year was 71% and at 3 years was 52% for those randomised to angioplasty first.
(ABSOLUTE trial)The randomized Balloon Angioplasty Versus Stenting With Nitinol Stents in the
Superficial Femoral Artery
104 pts with severe intermittent claudication (Rutherford class 3) or chronic critical limb ischemia with either rest pain(Rutherford class 4) or ischemic ulcers (Rutherford class 5) and a 50% stenosis or occlusion of the ipsilateral SFA with a target lesion length 30 mm and at least 1 patent (50% stenosis) tibioperoneal runoff vessel.
EP 1°= Restenosis rates at 2 years were 45.7% versus 69.2% in favor of primary
stenting compared with balloon angioplasty with optional stenting (p=0.03).
N Engl J Med 2006; 354:1879-1888
N Engl J Med 2006; 354:1879-1888
The randomized Balloon Angioplasty Versus Stenting With Nitinol Stents in the
Superficial Femoral Artery (ABSOLUTE) trial
Prevalence and Clinical Impact ofStent Fractures After Femoropopliteal Stenting
Dierk Scheinert, Susanne Scheinert, Matthias Ulrich, Giancarlo Biamino, Andrej SchmidtJ Am Coll Cardiol 2005;45:312–5
SMART stents (Cordis, ) were used in 52, SelfX stents (Abbott Medical Devices) in24, and Luminex stents (BARD) in 45 limbs, respectively.
Non fracturedstent
Fracturedstent
Fracture rates
13.2% = length 8 cm,
42.4% = 8 to 16 cm,
52.0% = > 16 cm
Stent fractures were detected in 37.2%
Michael Werk; Thomas Albrecht et al of PACIFIER Trial - Circ Cardiovasc Interv. 2012;5:00-00
(PACIFIER Trial) Paclitaxel-Coated Balloons Reduce Restenosis After Femoro- Popliteal Angioplasty
82.2
2.4
52.4
20.6
0
10
20
30
40
50
60
70
80
90
Permeabildad 1° TLR clínica
DCB PTA
p<0.001
p<0.001
Gunnar Tepe; John Laird et al - Circulation. 2015;131:495-502
(IN.PACT SFA) Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal
Lesions: 12-Month Results
%
✓ No major target limb amputations in either group (p>0.999) and low thrombosis rates of 1.5% in the IN.PACT™ Admiral™ DCB group, compared to 3.8% in the PTA group (p=0.243).
✓ In women, the primary patency rate was 73.3% for the IN.PACT™ Admiral™
DCB, compared to 45.8% in the PTA group (p<0.001).
✓In diabetic patients, the primary patency rate was 76.7% in the IN.PACT™
Admiral™ DCB group, compared to 42.3% in the PTA group (p<0.001).
Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions:24-Month Results of IN.PACT SFA
DCB vs PBA for femoropopliteal artery diseaseMetaanalysis of randomized clinical trial
Trial Tipo DCB Droga Dosis droga
Excipiente
PACIFIER IN.PACT pacific Paclitaxel 3 µ/mm2 Urea
THUNDER Paccocath Paclitaxel 3 µ/mm2 Iopromida
IN.PACT IN.PACT Admiral Paclitaxel 3,5 µ/mm2 Urea
LEVANT 2 Lutonix Paclitaxel 2 µ/mm2 Polysorbato y Sorbitol
Biolux P-I Passeo-18 lux Paclitaxel 3 µ/mm2 Butyryl-tri-n-hexylcitrato (BTHC)
Giacoppo D; Fusaro M; Kastrati A; J Am Coll Cardiol 2016; 9: 1731 – 42)
Trial SFA (%)
SFA +Poplitea
(%)
BTK + SFA + Poplitea
(%)
Longitud lesión (cm)
Oclusión total (%)
Stent bailout(DCB vs PTA -
%)
PACIFIER 100 100 0 6,8 31 9 vs 16
THUNDER 68 34 0 7,4 26 4 vs 22
IN.PACT 93 23 0 8,9 23 16 vs 14
LEVANT 2 91 43 0 6,3 21 2,5 vs 7
Biolux P-I 81 8 4 6 26 2 vs 26
Giacoppo D; Fusaro M; Kastrati A; J Am Coll Cardiol 2016; 9: 1731 – 42
DCB vs PBA for femoropopliteal artery diseaseMetaanalysis of randomized clinical trial
0
10
20
30
40
50
60
70
80
90
100
Permeabilidad primaria Libre de TLR
82
98
8994
6572
In.Pact (n=220) 3,5µ/mm2 ILLUMENATE (n=220) 2 µ/mm2 LEVANT 2 (n= 316) 2 µ/mm2
%
Konstantinos Katsanos ; J Am Coll Cardiol 2016; 9: 1743 – 45
COMPARE-Pilot RCT:1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB
in complex SFA lesions (n= 150 400 pts)
Reclutamiento finalizado
Resultados 2020
Jeffrey W. Olin, Christopher J. White et al – JACC 2016; 67: 1338 - 57
Gunnar Tepe, et al IN.PACT Global Study InvestigatorsJ Am Coll Cardiol Intv 2019;12:484–93
Chronic Total Occlusion Cohort in the IN.PACT Global Study
0
20
40
60
80
100
Éxito técnico POBA DCB Stent
91
36
13
54
95
39
27 27
Gpo A (n=43) Fem+BTK Gpo B (n=18) Fem puros
p=0,1*p=1
p= 0,7
p= 0,1
%
Impacto de la presencia de enfermedad infrapoplítea en el tratamiento de obstrucciones femoropoplíteas.
Costantini, R; Telayna JM(h); Telayna, JM; Pataro, M; Acosta Pimentel M.
Mundo real
Longer mean lesion length in DCB studiescorrelates with higher provisional stenting rate
Limitationsof Endovascular Treatment
Provisional Stenting
Treatment of Complex Atherosclerotic Popliteal Artery Disease With a New Self-Expanding Interwoven Nitinol Stent
12-Month Results of the Leipzig SUPERA Popliteal Artery Stent Registry
Scheinert D, Werner M, Scheinert S, Schmidt AJ Am Coll Cardiol Intv 2013;6:65–71
Spot Stenting Versus Long Stenting
After Intentional Subintimal Approach
for Long Chronic Total Occlusions of the Femoropopliteal Artery
Sung-Jin Hong - J Am Coll Cardiol Intv 2015;8:472–80
Real-world performance of paclitaxel drug-eluting bare metal stenting (Zilver PTX) for femoropopliteal occlusive disease
Chronic Total Occlusion 24 (46.1) - Treated lesion length, cm 20.15 ± 12.20
Tran K, Ullery B, Kret M, Lee J - Ann Vasc Surg. 2017;38:90-98
(ZILVERPASS study)Cook Zilver PTX drug-eluting stent versus bypass surgeryfor the treatment of femoropopliteal TASC C&D lesions:
Very complex lesions: 94.55% were occluded
and mean lesion length was
247.11mm
220 patients4 countries13 clinical
centers
The Leipzig Interventional Course - January 2019
MAJESTIC TrialEluvia PES for Femoropopliteal: 3-Year Follow-up
57 patients - long lesions (71± 28 mm); the patency rate: 91% and 82% at 1 and 2 years, respectively.
Kaplan–Meier estimate offreedom from TLR
S Muller Hulsbeck; K Keirse; T Zeller; H Schroe; J Diaz-CartelleCardiovascular and Interventional Radiological Society of Europe (CIRSE) 2017
1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty
62 patients were included.
32 patients (52%) presented with life-style-limiting claudication (Rutherford class 3) and 30 patients (48%) with CLTI (Rutherford class 4, n= 14 [23%];
class 5, n = 10 [16%]; class 6, n= 6 [10%]).
The majority of lesions (84%) were de novo. Mean lesion length was 20 ± 12 cm.
The median number of implanted stents was 1.5 stent per limb (interquartile range: 1 to 3).
Theodosios Bisdas et al - JACC Cardiovasc Interv Vol 11(10) 2018
1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty
Amputation-free survival was 100% in patients with claudication and 87% in those with critical limb ischemia. Two patients underwent major amputations (at 2 and 6 months).
Aneurysmal degeneration of the arterial wall (mean diameter 14 mm) in 5 patients (8%).
Theodosios Bisdas et al - JACC Cardiovasc Interv Vol 11(10) 2018
A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for
endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial
The superficial femoral and/or proximal popliteal artery lesions up to 140 mm in
length (85mm average).
(Sub-study = longer lesions between 140 and 190 mm ).
Enroll up to 535 patients at up to 75 sites worldwide
and provide up to 5 years of follow-up
Gray Williams et al behalf IMPERIAL trial – Lancet 2018; 392 sep 24
A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for
endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial
Gray Williams et al behalf IMPERIAL trial – Lancet 2018; 392 sep 24
FDA finds 50% higher risk of 5-year mortality with paclitaxel PAD productsMarch 15, 2019
The FDA’s own preliminary analysis included three trials with at least five years of follow-up data.
“While the analyses are ongoing, our preliminary review of this data has identified a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products compared to patients treated with uncoated devices,” the agency stated. “In total, among the 975 subjects in these 3 trials, there was an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coated devices versus those treated with control devices (20.1% versus 13.4% crude risk of death at 5 years).”
The FDA acknowledged pooling the studies may lead to a “greater uncertainty in the results” and said the specific cause and mechanism of the higher mortality rates is unknown. Nevertheless, the agency said it would convene an advisory committee meeting of its Circulatory System Devices Panel to discuss those potential mechanisms, facilitate a discussion on the long-term mortality signal, consider modifications to U.S. clinical trials of paclitaxel products and re-examine the benefit-risk profile for these devices.
The Leipzig Interventional Course - January 2019
The Leipzig Interventional Course - January 2019
REAL PTX (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of
the Femoropopliteal Artery) studyProspective randomized controlled trial including 150 patients with symptomatic femoropopliteal arterial disease (Rutherford category 2 to 5) centers located in Germany and Belgium.De novo or restenotic femoropopliteal lesions not exceeding the medial femoral epicondyle, a lesion length ≤30 cm, and at least 1 patent tibial runoff vessel.
Yvonne Bausback, Andrej Schmidt, Thomas Zeller, Marc Bosiers, Dierk Scheinert, Sabine SteinerJ Am Coll Cardiol 2019;73:667–79
REAL PTX (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of
the Femoropopliteal Artery) study
Yvonne Bausback, Andrej Schmidt, Thomas Zeller, Marc Bosiers, Dierk Scheinert, Sabine SteinerJ Am Coll Cardiol 2019;73:667–79
REAL PTX (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of
the Femoropopliteal Artery) study
Yvonne Bausback, Andrej Schmidt, Thomas Zeller, Marc Bosiers, Dierk Scheinert, Sabine SteinerJ Am Coll Cardiol 2019;73:667–79
Stenotic lesions
Long lesions(>10cm)
Decidir “qué dejar detrás”
DCB: LEVANT 2 IN.PACT GLOBAL STUDYILLUMENATE RCT
Bailout or provitional stent 6% - 21%
“Preparación del vaso”
Insuflaciones prolongadas (varios minutos)Balones no complacientes / balones de corte (cutting balloon)AterótomosLitotrisia intravascular (Litoplastia)
La inevitable necesidad de stent
Tipo de stent: Zilver PTX DES / IMPERIAL (Eluvia DES)
Conclusiones:
Enfermos con arteriopatía periférica: subdiagnóstico y sub tratamiento en comparación con enfermedad coronaria.
Programa conjunto paralelo de actividad física supervisada y revascularización.
Dispositivos endovasculares liberadores de droga (balones y stents) han demostrado su eficacia y durabilidad.
La combinación de tecnologías (debulking seguido por DCB) ofrecen una atractiva alternativa a evaluar.
Procedimiento correcto en el paciente correcto en el momento correcto.
Muchas Gracias