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

fabrizio.fanelli@uniroma1.it