vascular & interventional radiology unit department of radiological sciences
DESCRIPTION
N EW TECHNOLOGIES: Wires, balloons, drug-eluting devices, ect . Fabrizio Fanelli . Vascular & Interventional Radiology Unit Department of Radiological Sciences “ Sapienza” – University of Rome. Below The Knee Arteries. Small vessels Long lesions Occlusions > stenoses - PowerPoint PPT PresentationTRANSCRIPT
Vascular & Interventional Radiology UnitDepartment of Radiological Sciences“Sapienza” – University of Rome
Fabrizio Fanelli
NEW TECHNOLOGIES: Wires, balloons, drug-eluting devices, ect.
Small vessels
Long lesions
Occlusions > stenoses
More vessels
CalcificationsIliac Femoral Popliteal Peroneal Post Tib Ant Tib
0
100
200
300
400
500
600
700
StenosisOcclusion
L. Graziani – Eur J Vasc Endovasc Surg 2007
Below The Knee Arteries
55% FEM-POP
96% BTK
5% ATG
CLI : Mean Length Treated lesions
185±121 mm
116±113 mm
63±61 mm
R.Ferraresi - oral presentation CICE 2012
PTA F.U. PATENCY TLRDEBATE 1 12 mos 28.0% 24.0%
Leipzig Registry2 3 mos 31.0 % 50.0%
DEBELLUM 3 12 mos 47.1% 47.0%
BMS F.U. PATENCY TLR
ACHILLES4 12 mos 57.1% 16.0%
DESTINY5 12 mos 54.3 % 33.6%
YUKON6 12 mos 55.6% 13.0%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
…. New Technologies ….
Micro-puncture set Guidewires Micro-guidewires Introducers Support catheters Low profile balloon catheters Atherectomy devices Drug eluting balloons (DEB) Bare metal stents Drug eluting stents (DES)
Micro-puncture set Guidewires Micro-guidewires Introducers Support catheters Low profile balloon catheters Atherectomy devices Drug eluting balloons (DEB) Bare metal stents Drug eluting stents (DES)
Drug Eluting Balloons
In.Pact Amphirion – Medtronic /Invatec Advance LP 18 PTX – Cook Freeway II/Dior – Eurocor Elutax – Aachen Medical
Study type Prospective single center, single arm, investigator initiated study
Objective Assess IN.PACT Amphirion™ efficacy for the treatment of long BTK lesions occlusions
Population Symptomatic patients with CLI or severe claudication
Eligibility At least one lesion BTK ≥ 80 mm
Prim. Endpoint 3 month restenosis rate
Nr of patients 104 / 109 limbs
IN.PACT™ Amphirion inreal world BTK complex lesions
A. Schmidt – JACC 2011
DEB BTK Leipzig Registry
DEB(angio
subgroup)
PTA(historical
group)
# patients / limbs 74 / 79 58 / 62
Male gender 51 (68.9%) 38 (65.5%)
mean age (y) 73.5 ± 9.3 70.5 ± 8.08
diabetics 54 (73%) 52 (89.7%)
Renal insuff. 34 (45.9%) 30 (51.7%)
RC 3 16 (20.3%) 0 (0%)
RC 4 14 (17.7%) 16 (25.8%)
RC 5 49 (62%) 46 (74.2%)
RC 6 0 (0%) 0 (0%)
avg lesion length 173 ± 87 mm 183 ± 75 mm
Tot occlusions 61.9% 64.9%
DEB(angio subgroup)
PTA(historical group)
3m Ang. FURestenosis (>50%) 27.4% 69%
Full-segment Resten. 10% 56%
Restenosis Length 64 mm 155 mm
12m Clinical FU
15m Clinical FU
Deaths 16.3% 10.5%
Limb Salvage 95.6% 100%
Clinical Improvement (1) 91.2% 76.5%
Compl. wound healing 74.2% 78.6%
TLR 17.3% 50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions 2010)
DEB BTK Leipzig Registry
DEB(angio
subgroup)
PTA(historical
group)
# patients / limbs 74 / 79 58 / 62
Male gender 51 (68.9%) 38 (65.5%)
mean age (y) 73.5 ± 9.3 70.5 ± 8.08
diabetics 54 (73%) 52 (89.7%)
Renal insuff. 34 (45.9%) 30 (51.7%)
RC 3 16 (20.3%) 0 (0%)
RC 4 14 (17.7%) 16 (25.8%)
RC 5 49 (62%) 46 (74.2%)
RC 6 0 (0%) 0 (0%)
avg lesion length 173 ± 87 mm 183 ± 75 mm
Tot occlusions 61.9% 64.9%
DEB(angio subgroup)
PTA(historical group)
3m Ang. FURestenosis (>50%) 27.4% 69%
Full-segment Resten. 10% 56%
Restenosis Length 64 mm 155 mm
12m Clinical FU
15m Clinical FU
Deaths 16.3% 10.5%
Limb Salvage 95.6% 100%
Clinical Improvement (1) 91.2% 76.5%
Compl. wound healing 74.2% 78.6%
TLR 17.3% 50%
(1) clinical improvement = reduction in size and/or depth of ulceration or improvement of rest-pain
vs historical PTA cohort (A.Schmidt - Cath. and Cardiovasc. Interventions 2010)
DEB BTK Leipzig Registry
Investigator initiated, single center StudyRandomized (1:1) DEB vs. standard PTAPrimary Endpoint: 12-month
AngiographicBinary (>50%) Restenosis RateSecondary Endpoints: TLR and
Reocclusion
CLI + Diabetes150 (Tibial) Lesions
DEB(75 lesions)
Std PTA(75 lesions)
12-month Angiographic
and Clinical follow-up
Aspirin + Clopidogrel (1 month)
24-month Duplexand Clinical follow-up
Random (1:1)
• Key Inclusions• RC 4-5-6 and Diabetes• Stenosis / occlusions >40 mm in at
least 1 tibial vessel with distal run-off• Key Exclusions
• Allergy to Paclitaxel• Contraindication for combined
antiplatelet treatment• Life expectancy <1 year
DEBATE BTK
F. Liistro - oral presentation TCT 2012
DEB PTA pPatients 65 67 /Age 74±9.4 75±9.6 0.7Smoke 13 (20%) 7 (10.4%) 0.1Hypertension 46 (70.8%) 52 (77.6%) 0.4Hypercholesterolemia 23 (35.4%) 16 (23.9%) 0.1Diabetes 65 (100%) 67 (100%) 1Obesity 23 (35.3%) 26 (38.8%) 0.5Dialysis 7 (10.8%) 7 (10.4%) 1
Coronary artery disease 12 (18.5%) 10 (14.9%) 0.6
Limbs 71 72 0.9Texas wound ulcer class. I C 1 (1.4%) 3 (4.2%)
0.5
II C 3 (4.2%) 5 (6.9%) I D 7 (9.9%) 9 (12.5%) II D 34 (47.9%) 32 (44.4%) III D 26 (36.6%) 23 (31.9%)
• Key Inclusions– Fontaine Stage IIb, III, IV – SFA, popliteal and BTK lesions
either isolated or concomitant– De-novo lesions – Stenosis or occlusions 3 - 30 cm
Investigator initiated, single center StudyRandomized (1:1) DEB vs. standard PTAPrimary Endpoint: 6-month LLLSecondary Endpoints: TLR, Primary
Patency, Fontaine change, MAE at 6 and 12 months
DEBELLUM Drug Eluting Balloon Evaluation for Lower Limb mUltilevel treatMent
F. Fanelli - oral presentation CIRSE 2012
analysis per lesion
12-mos TLR
DEB PTA DEB PTAAngio 6 mos Angio 6 mos Angio 12 mos Angio 12 mos
Restenosis rate 15.3% (2 lesions)
41.1% (7 lesions)
23.07% (3 lesions)
52.9% (9 lesions)
TLR 7.69% (1 lesion)
23.5% (4 lesions)
15.3% (2 lesions)
47.0% (8 lesions)
Occlusion rate 0 9.1% 0 9.1%Death 0 0 0 0
Major amputation 10% (1 patient)
9.09% (1 patient)
10% (1 patient)
9.09% (1 patient)
Minor amputation 0 18.8% (2 patients) 0 18.8%
(2 patients)
DEBELLUM - 12 mos F.U.
• Prospective Randomized Multicenter Trial
• 50 pts.• RC: 4-6• >50% calcified stenosis• popliteal, tibial and peroneal aa.
OA + PTA PTA pStenting 6.9 % 14.3 % 0.44
Dissection 6 pts 1 pts ns
Perforation / 1 ns
Distal Embolization / 1 ns
Max Inflation Press <0.001
2 - 4 59.3 % 11.8 %
5 - 6 14.8 % 8.8 %
7 - 8 7.4 % 26.5 %
9 - 10 7.4 % 32.4 %
11 - 12 0 8.8 %
>12 11.1 % 11.8 %
Mean 5.9 ± 4.2 9.4 ± 3.8
OA + PTA PTA pStenting 6.9 % 14.3 % 0.44
Dissection 6 pts 1 pts ns
Perforation / 1 ns
Distal Embolization / 1 ns
Max Inflation Press <0.001
2 - 4 59.3 % 11.8 %
5 - 6 14.8 % 8.8 %
7 - 8 7.4 % 26.5 %
9 - 10 7.4 % 32.4 %
11 - 12 0 8.8 %
>12 11.1 % 11.8 %
Mean 5.9 ± 4.2 9.4 ± 3.8
Secondary Endpoints
PTA F.U. PATENCY TLRDEBATE 1 12 mos 28.0% 24.0%
Leipzig Registry2 3 mos 31.0 % 50.0%
DEBELLUM 3 12 mos 47.1% 47.0%
DEB F.U. PATENCY TLRDEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
What about Stent … ?
DEB F.U. PATENCY TLRDEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
BMS F.U. PATENCY TLR
ACHILLES4 12 mos 57.1% 16.0%
DESTINY5 12 mos 54.3 % 33.6%
YUKON6 12 mos 55.6% 13.0%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
DEB F.U. PATENCY TLRDEBATE 1 12 mos 71.0% 13.0%
Leipzig Registry2 3 mos 72.6 % 17.3%
DEBELLUM 3 12 mos 76.9% 15.3%
DES F.U. PATENCY TLR
ACHILLES4 12 mos 75.0% 10.0%
DESTINY5 12 mos 85.2 % 8.7%
YUKON6 12 mos 80.6% 13.8%
3) F. Fanelli - oral presentation CIRSE 2012 2) A. Schmidt – JACC 2011
1) F. Liistro - oral presentation TCT 2012
6) A. Rastan – European Heart Journal 20115) M. Bosiers – J Vasc Surg 2012
4) K. Katsanos - oral presentation CIRSE 2011
Everolimus-eluting stent vs. bare metal stent
103 pts. CLI
Angioplasty + Bailout stenting
JVIR 2009; 20(9):1141-1150
D. Siablis – JVIR 2009; 20(9):1141-1150
HR: 4.8, CI 2.9-7.9 p<0.001 HR: 2.5, CI 1.3-5.0 p=0.006
Xcience-Prime Xcience-Prime
Conclusions
DEB patency rate similar to DES but with the advantage of
“nothing left behind”.
Efficacy of DEB in very calcified arteries still under evaluation
Combined treatment with atherectomy must be validated.
The Future …
• Adaption to flexion, extension•Overcome Stent fractures•Positive Remodelling•Might act as a transporter (Gen-Therapy)•Surgeon’s friend
Bioabsorbable Stent
Poly-L-lactide + Everolimus30 pts.
ABSORB Study
5-y F.U.- No cardiac death- No thrombosis- MACE: 3.4 %- LLL 0.27 mm