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IN.PACT DEB TECHNOLOGY
CLINICAL TRIAL OVERVIEW
SFA RESULTS
BTK RESULTS
ORDER INFORMATION
& ABBREVATIONS
IN.PACT DEB Technology andClinical Evidence
IN.P
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DEB
Tech
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SFA
Resu
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Orde
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Abbr
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IN.P
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DEB
Tech
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SFA
Resu
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Orde
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Abbr
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ORDER INFORMATION
& ABBREVATIONS
IN.PACT DEB Technology andClinical Evidence
BTK RESULTS
SFA RESULTS
CLINICAL TRIAL OVERVIEW
IN.PACT DEB TECHNOLOGY
4 DEB Components
FreePac Coating Technology
How to use a DEB
IN.PACT PACLITAXEL!ELUTING BALLOONS
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IN.PACT DEB TECHNOLOGY4 DEB components interweaving towards performance...
1. PLATFORMMEDTRONIC INVATEC
proven PTA full balloon line
PACLITAXELhydrophobic, lipophilic,
proven antiproliferative drug2. DRUG
UREAhydrophilic,
non toxic3. EXCIPIENT
MEDTRONIC INVATECuniformity + stability + release
controlled and scaleable4. COATING TECH
IN.PACT AmphirionPaclitaxel-Eluting PTA Balloon Catheter 0.014”
IN.PACT AdmiralPaclitaxel-Eluting PTA Balloon Catheter 0.035"
IN.PACT Paci!cPaclitaxel-Eluting PTA Balloon Catheter 0.018"
TECHNOLOGY
Clin
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Tria
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BtK
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.PAC
T D
EB Te
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Clin
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Tria
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BtK
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.PAC
T D
EB Te
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
IN.PACT PACLITAXEL!ELUTING BALLOONS
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FOLDS UNWRAPPINGThe balloon unwraps to
expose the FreePac coating
BALLOON INFLATED AND ELUTINGUrea molecules facilitate carriage of pacli taxel molecules across the
vessel wall
ELUTIONDrug elution takes place
within 30 - 60 seconds
DRUG UPTAKECOMPLETED
WRAPPED BALLOONThe IN.PACT DEB is
delivered to the target site
IN.PACT Paclitaxel elution timeline10 SECONDS 15 SECONDS 60 SECONDS
IN.PACT DEB TECHNOLOGY
TECHNOLOGY
IN.PACT™ DEB WITH FREEPAC™ COATING TECHNOLOGY
IN.PACT™Medtronic Invatec DEB balloon line
FREEPAC™Proprietary hydrophilic coating formulation– Urea separates Paclitaxel molecules– Increased drug solubility and optimal diffusion
into vessel wall– Urea facilitates Paclitaxel absorption into the vessel wall
PACLITAXEL - proven antiproliferative
UREA - natural and hydrophilic excipient
Clin
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.PAC
T D
EB Te
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
IN.PACT PACLITAXEL!ELUTING BALLOONS
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IN.PACT DEB TECHNOLOGY
FOLDED BALLOON
Handle with care
Lesion 2, DEB 2Lesion 1, DEB 1
2. Pre-dilatation
3. DEB
1. Lesion
Duration time 30 - 60 sec.
overlap overlap IF A STENT IS PRESENT AN OVERLAP WITH DEB IS RECOMMENDED
DRUG RELEASE WITHIN 30 ! 60 SECONDS• Longer inflation times are possible at
discre t ion of operator - to pursue optimal mechanical dilatation - but do not lead to further drug release
PRE!DILATATION RECOMMENDED IN CERTAIN CASES• For pre-dilatation in case of total occlusions
or sub-occlusive lesions use a standard balloon (approx. 0.5 mm smaller than RVD)
• Choose a DEB with a nominal size equal to reference diameter
ONE DRUG!ELUTING BALLOON FOR EACH LESION• For single use only, drug is released upon
the first inflation • In longer lesions DEB overlapping is indicated
HANDLE WITH CARE• DEB surface can be touched and handled gently• Do not rub the coated balloon• Do not use any protective / insertion sheath to
advance the DEB trough the introducer sheath and/or hemostatic valve
HOW TO USE DRUG ELUTING BALLOONS
TECHNOLOGY
IN.P
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DEB
Tech
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SFA
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IN.PACT DEB TECHNOLOGY
IN.PACT DEB Technology andClinical Evidence
BTK RESULTS
SFA RESULTS
ORDER INFORMATION
& ABBREVATIONS
CLINICAL TRIAL OVERVIEW
IN.PACT Clinical Trial Program
IN.P
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DEB
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OVERVIEW
STATUS DATE: 01/2012
Indication Design # Sites ArmsPrimary Endpoint Pl(s) #Pts
SFAIN.PACT SFA I SFA de-novo RCT 10 DEB vs PTA +
prov Stent12m Prim. Patency
G. Tepe 150
IN.PACT SFA II SFA de-novo RCT 50 DEB vs PTA + prov Stent
12m Prim. Patency
P. Schneider, J. Laird
280
DEB SFA IT Registry* SFA de-novo Registry 6 DEB + prov Stent
6m Patency A. Micari 105
PACIFIER* SFA de-novo RCT 3 DEB vs PTA + prov Stent
6m LLL M. Werk 91
ISAR-STATH* SFA de-novo RCT 2 DEB + Stent vs Stent vs Ather.
6m %DS I. Ott, M. Fusaro
150
IN.PACT CALCIUM* SFA de-novo Ca++
Registry 1 Atherectomy + DEB
12m RR (DUS) A. Cioppa 20
SFA-ISRPHOTOPAC* SFA ISR RCT 3 Laser + DEB vs
DEB alone12m %DS T. Zeller 50
FAIR* SFA ISR RCT 3 DEB vs PTA 6m DUS re-restenosis
H. Kranken-berg
118
ISAR PEBIS* SFA ISR RCT 1 DEB vs PTA 6m %DS I. Ott, M. Fusaro
70
FRENCH SFA Registry* SFA ISR Registry 13 DEB 12m TLR Y. Gouë!c 100
SFA & BTKDEBELLUM* SFA BTK RCT 1 DEB vs PTA 6m LLL F. Fanelli 50
BTKDEB BTK IT Registry* BTK de-novo Registry 6 DEB + prov
Stent6m RR (Angio) G. Biamino 100
IN.PACT BTK Abano* BTK de-novo Registry 1 DEB + prov Stent
6m RR (Angio) M. Manzi 122
IN.PACT BTK DEB Leipzig Registry*
BTK de-novo Registry 1 DEB + prov Stent
3m RR (Angio) D. Scheinert 107
IN.PACT DEEP BTK / CLI de-novo
RCT 11 DEB vs PTA + prov Stent
12m LLL + TLR + 6m Events
I. Baumgart-ner, T. Zeller, D. Scheinert
357
DEBATE* BTK/CLI/ Diabetics
RCT 1 DEB vs PTA + prov Stent
12m Angio RR F. Liistro 150
16 Clinical Trials / 10 RCT / 113 Clinical Sites / 2.020 patients
IN.PACT CLINICAL TRIAL PROGRAM
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* Physician sponsored
IN.P
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DEB
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IN.PACT DEB TECHNOLOGY
ORDER INFORMATION
& ABBREVATIONS
IN.PACT DEB Technology andClinical Evidence
BTK RESULTS
CLINICAL TRIAL OVERVIEW
SFA RESULTS
Italian SFA Registry
SFA Trial PACIFIER
SFA Trial DEBELLUM
CAS,
Sup
raor
tic
IN.PACT AdmiralPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.035"
IN.PACT drug-eluting balloon demonstrates high primary patency with low stent rateData presented at PCR 2011 by Dr. Micari
REGISTRY PURPOSETo assess the benefit of DEB usage within standard practice for the treatment of femoro-popliteal arterial disease in patients with claudication and rest pain
PRIMARY ENDPOINT The primary endpoint was primary patency at 12 months
STUDY METHODS- Investigator sponsored multi-center observational registry- Predilatation with conventional undersized PTA balloon, DEB dilatation for 180 sec- Provisional stenting in case of flow limiting dissections and persistent residual
stenosis > 50%
PATIENT DEMOGRAPHICS
DEB SFA ITALIAN REGISTRY
* Micari et al., EuroIntervention Volume 7, Supplement K, May 2011, A new paclitaxel-eluting balloon for angioplasty of femoro-popliteal obstructions: acute and midterm results
HypertensionHyperlipidaemia
DiabetesInsul. dependant
Renal insufficiencySmoking
Coronary Artery Dis.Carotid Artery Dis.
!105 PATIENTS, AGE 68 ± 9"
Average Lesion Length: 76mm. Total Occlusions: 29.8%. ABI 0.56 ± 0.15Rutherford Class II 26,7%, Rutherford Class III 64,8%, Rutherford Class IV 7.6%
DEB SFA ITALIAN REGISTRY*
DRUG#ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE
10 20 30 40 50 60 70 80 90 100
90 (85.7%)78 (74.3%)
51 (48.6%)23 (45.1%)
2 (1.9%)66 (62,8%)
45 (42.9%)15 (14.3%)
STATUS DATE: 02/2012
SFADE!NOVO
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PTA
Ballo
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IN.PACT AdmiralPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.035”
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
REGISTRY CONCLUSION & DISCUSSION
12 MONTHS RESULTS
– High primary patency rate and low TLR rate despite conservative usage of stents– Clinical benefit is consistently shown across multiple endpoints Patency rates are in line with previously reported results of Drug Eluting Balloons (Thunder, Fempac)**
– Primary Patency 83.7%– TLR rate 8.7%– ABI, Quality of Live,
Walking capacity, Rutherford class improvements
DEB SFA ITALIAN REGISTRY IN.PACT drug-eluting balloon demonstrates high primary patency with low stent rate
ACUTE OUTCOME
Device Success · · · · · · · · · · · · · · · · · · · · · · 135 (100%)
Stenting · · · · · · · · · · · · · · · · · · · · · · 14 (12.3%)
Tech. Success · · · · · · · · · · · · · · · · · · · · · · 121 (89.6%)
Pre-dilatation · · · · · · · · · · · · · · · · · · · · · · 113 (99.1%)
DEB inflation time · · · · · · · · · · · · · · · · · · · · · · 181 ± 20.4 sec
No DEB p/lesion · · · · · · · · · · · · · · · · · · · · · · 135/114 = 1.18
** Tepe et al., N Engl J Med 2008; 358:2406-2407 / Werk et al., Circulation. 2008; 118: 1358-1365
0 180 360
100%90%80%70%60%50%40%30%20%10%
12M Survival from TLR, Occlusion, >50% Restenosis Primary Patency 83.7%
days after procedure
PSVR <2.5
STATUS DATE: 02/2012
SFADE!NOVO
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Sten
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IN.PACT PacificPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.018"
IN.PACT drug eluting balloon superior to PTA with regards to 6 months Late Lumen LossData presented at LINC 2012 by Dr. Werk
STUDY PURPOSETo demonstrate efficacy of the paclitaxel eluting balloon to inhibit restenosis of femoropopliteal stenosis and occlusions vs. standard PTA
PRIMARY AND SECONDARY ENDPOINTS - The primary endpoint was Late Lumen Loss (LLL) at 6 months- Secondary endpoints: 6-m binary restenosis rate, 6-m TLR, 6-m RC change,
6-m event free survival
STUDY METHODS- Investigator sponsored multi-center randomized (1:1) trial- Independent, blinded Angiographic Corelab- Provisional stenting in case of flow limiting dissection or persistent residual stenosis
PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS
THE PACIFIER TRIAL
* A Randomized Multicenter Trial Evaluating Prevention of Restenosis with Paclitaxel-Coated PTA Balloon Catheters in Stenosis or Occlusion of Femoropopliteal Arteries
M. Werk, T. Albrecht, D.-R. Meyer, H. Stiepani, B. Schnorr, U. Dietz, E. Lopez Hänninen
Departments of Radiology of the Martin-Luther-Hospital, Hubertus-Hospital, Vivantes Klinikum Neukölln, Berlin, Germany
presented at LINC 2012
SFA TRIAL " PACIFIERDRUG!ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE
DEB Control
No. of Patients n 44 47Mean Age y ± SD 71 ± 7 71 ± 9
Diabetes n (%) 19 (43%) 13 (28%)Hypertension n (%) 29 (66%) 31 (66%)
Hypercholesterolemia n (%) 22 (50%) 22 (47%)ABI mean ± SD 0.73 ± 0.30 0.65 ± 0.26
95% of patients were in Rutherford classes 2 or 3 at baseline.
Avg lesion length cm ± SD 7.0 ± 5.3 6.6 ± 5.5Ref. Vessel Diameter mm 4.92 4.90 % Diameter Stenosis (%) 73% 80%
Total Occlusions n (%) 10 (23%) 18 (38%)
68% (DEB arm) were de-novo lesions, but also restenotic and ISR was included in the protocol.
SFADE!NOVO
STATUS DATE: 02/2012
Go
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IN.PACT PacificPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.018”
©20
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
CONCLUSION
6 MONTHS RESULTS !ANGIOGRAPHIC AND CLINICAL"
IN.PACT PACIFIC™ confirms to effectively reduce neointima hyperplasia in SFA with a significant decrease in LLL at 6 months vs standard PTA Clinical Events (Secondary Endpoints) trend / are in favor of DEBNo coating related adverse events noted
SFA TRIAL " PACIFIER IN.PACT drug eluting balloon superior to PTA with regards to 6 months Late Lumen Loss
ACUTE OUTCOME
DEB Control P valuePre-Dilatation n (%) 6 (13.6%) 3 (6.4%) 0.30
Balloon inflation time mean ± SD 76 ± 33 sec 76 ± 25 sec 0.89Dissections n (%) 18 (41%) 25 (53%) 0.48
Provisional Stent Rate n (%) 9 (21%) 16 (34%) 0.17Residual Stenosis mean±SD 12±12% 11±12% 0.5
DEB Control P value% Diameter Stenosis % 29.7% 39.4% 0.05
Min. Lumen Diameter mm 3.61 2.94 0.0014Binary Restenosis n/N (%) 3/35 (8.6%) 11/34 (32.4%) 0.01
Late Lumen Loss mm -0.01 0.65 0.0014
30% –
25% –
20% –
15% –
10% –
5% –
0% –
TLR Amputation Death Composite
6M MAJOR ADVERSE EVENTS
DEB
Control
SFADE!NOVO
7.1% 7.1%
21.4%
p=0.12
p=0.04
26.2%
0.0% 0.0% 0.0%
4.8%
STATUS DATE: 02/2012
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IN.PACT drug eluting balloon superior to PTA with regards to 6 months Late Lumen LossData presented at MEET 2011 by Dr. F. Fanelli
STUDY PURPOSETo assess the effect of DEB for multilevel lower limb revascularization compared to PTA
PRIMARY AND SECONDARY ENDPOINTS - The primary endpoint was Late Lumen Loss (LLL) at 6 months (US evaluation)- Secondary endpoints: Target Lesion Revascularization, Thrombosis and Amputation
STUDY METHODS– Investigator sponsored single-center randomized (1:1) trial– Provisional Stenting in case of flow limiting dissection or persistent residual stenosis– Study devices: IN.PACT Amphirion (BtK) and IN.PACT Admiral (SFA)
STUDY DESIGN
PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS
DEBELLUM
* Dr. Fabrizio Fanelli Vascular and Interventional Radiology Unit Department of Radiological Sciences “Sapienza” - University of Rome
presented at MEET 2011
DEBELLUM: Drug Eluting Balloon Evaluation for Lower Limb mUltilevel treatMent*
DRUG!ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE
Patient Demographics
Patients n 50Age y 67 ± 21
Diabetes 22 (45%)High Cholesterol 29 (59%)
Hypertension 34 (68%)ABI 0.53 ± 0.18
Fontaine Stage 2b 31 (62%)Fontaine Stage 3 14 (28%)Fontaine Stage 4 5 (10%)
Lesion Characteristics
Overall Lesions 122Femoro-Popliteal Lesions 92 (76%)
BtK Lesions 30 (24%)Mean Lesion Length (cm) 7.5 ± 3.5
% Stenosis Diameter 85 ± 6.4
Total Occlusion 26 (22%)
N= 50 PTS. PRIMARY ENDPOINT: LATE LUMEN LOSS AT 6 MONTHS
N= 25 pts | 57 lesions
Native Stenosis (26 lesions)
Stenting (31 lesions)
Native Stenosis (30 lesions)
Stenting (35 lesions)
N= 25 PTS | 65 LESIONSDEB
Uncoated balloons
STATUS DATE: 02/2012
SFA/BTK
IN.PACT AdmiralPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.035"
IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014"
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
CONCLUSION
6 MONTHS SUBANALYSIS
Drug eluting balloons are safe and effective for the inhibition of neointimal hyperplasiaNo significative different results between native stenosis and post-stents dilatationSix-months follow-up showed lower neointimal hyperplasia, lower TLR rates and better clinical outcomes in the DEB group compared with the non-coated balloon group.*
DEBELLUM: Drug Eluting Balloon
Evaluation for Lower Limb mUltilevel treatMent
IN.PACT drug eluting balloon superior to PTA with regards to 6 months Late Lumen Loss
6 MONTHS RESULTS !ANGIOGRAPHIC AND CLINICAL"
SECONDARY ENDPOINTSTLR clinically and diagnostic (USCD or DSA) driven
Overall analysis: 0.5±1.4mm (DEB) vs 1.6±1.7mm (PTA). P<0.01Native stenosis analysis: 0.5mm (DEB) vs 1.5mm (PTA. P<0.01Stent analysis: 0.51mm (DEB) vs 1.7mm (PTA). P<0.01
DEB
PTA
STATUS DATE: 02/2012
* the study was not powered against secondary endpoints.
DRUG!ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE
SFA/BTK
2.0 mm –
1.5 mm –
1.0 mm –
0.5 mm –
0 mm –Overall values Native Stenosis
AnalysisStent Analysis
0.5 0.5 0.51
1.6 1.51.7
40% –
30% –
25% –
20% –
15% –
10% –
5% –
0% –TLR Thrombosis Amputation
8 7
3
36
128
DEB
PTA
IN.PACT AdmiralPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.035"
IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014"
IN.P
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DEB
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IN.PACT DEB Technology andClinical Evidence
ORDER INFORMATION
& ABBREVATIONS
IN.PACT DEB TECHNOLOGY
SFA RESULTS
CLINICAL TRIAL OVERVIEW
BTK RESULTS
BtK DEB Leipzig Registry
DEBATE-BtK
IN.P
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IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014"
BTK DEB LEIPZIG REGISTRYIN.PACT drug eluting balloon reduces early restenosis and TLR Rate of long BtK lesions
REGISTRY PURPOSEThe purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result.
PRIMARY ENDPOINT The primary endpoint was the angiographic binary restenosis.
STUDY METHODSInfrapopliteal angioplasty was performed with an IN.PACT AMPHIRION paclitaxel-eluting balloon clinical and angiographic follow-up was performed at 3 months to detect bina-ry restenosis, and further clinical assessment was performed over a 12-month period.
BTK REGISTRY
* Schmidt et al. J Am Coll Cardiol.2011; 58: 1105-1109
** Schmidt et al. Catheterization and Cardiovas-cular Interventions, 76:!1047–1054
A. Schmidt, MD Center of Vascular Medicine Angiolo-gy, Cardiology and Vascular Surgery Park Hospital Leipzig, Germany
10 20 30 40 50 60 70 80 90 100
PATIENT DEMOGRAPHICS (104 Patients, Age 73.6 ± 6.7, Male 69 =66.3%)
Arterial hypertensionDiabetes mellitus
Smoking habitHypercholesterolemia
Obesity Coronary artery disease
NYHA functional classes III and IV Renal insufficiency (GFR 60 ml/min/1.73 m2)
Cerebrovascular disease
95 (91.3%)74 (71.1%)
32 (30.8%)68 (65.4%)
33 (31.7%)47 (45.9%)
23 (22.1%)48 (46.2%)
19 (18.3%)
STATUS DATE: 01/2012
BTKDE!NOVO
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014”
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REGISTRY CONCLUSION & DISCUSSIONThe early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons.
A historical control group** with similar patients showed 69% binary restenosis rate at 3 months, 56% restenosis of the whole segment and a TLR rate of 50% at 15 months. DEB resulted in better restenosis rate at 3 months, lower rate of totally occluded arte-ries and lower TLR rates.
BTK DEB LEIPZIG REGISTRY IN.PACT drug eluting balloon reduces early restenosis and TLR Rate of long BtK lesions
CLINICAL RESULTS
RUTHERFORD SHIFT !12.5 MONTHS"
TLR at 12 months · · · · · · · · · · · · · · · · · · · · · · · · · 17.4%
Rate of completely occluded arteries · · · · · · · · · · · · · · · · · · · · · · · · · 9.5%
Binary restenosis rate at 3 months · · · · · · · · · · · · · · · · · · · · · · · · · 27.4%
Clinical improvement · · · · · · · · · · · · · · · · · · · · · · · · · 95.6%
Complete wound healing · · · · · · · · · · · · · · · · · · · · · · · · · 74.2%
Favourable clinical results and a limb salvage rate of 95.4%
70605040302010
0 0 1 2 3 4 5 6
Num
bers
of l
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mid-term FU
Rutherford-Becker categories
1 (0
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19 (1
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19 (1
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ANGIOGRAPHIC RESULTSMean infrapopliteal lesion length was 17.6mm. Angiography at 3 months found 72.6% of all arteries free of significant restenosis.
1 (9.1%)
5 (9.3%)9 (20.0%)
7 (18.9%)5 (38.5%)
15 (31.3%)3 (16.7%)
3 (16.7%)5 (31.3%)
Distal poplitealAnterior tibial arteryTibioperone al trunk
Posterior tibial arteryPeronal artery
Proximal segment of tibial arteriesMid segment of tibial arteries
Distal segment of tibial arteriesArteries distal to the malleolus
5 10 15 20 25 30 35 40
3 MONTHS ANGIOGRAPHIC RESTENOSIS RATE BY VESSEL DISTRICT !104 PATIENTS, AGE 73.6 ± 6.7"
STATUS DATE: 01/2012
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CLINICAL RESEARCH Interventional Cardiology
First Experience With Drug-Eluting Balloonsin Infrapopliteal ArteriesRestenosis Rate and Clinical Outcome
Andrej Schmidt, MD,* Michael Piorkowski, MD,* Martin Werner, MD,* Matthias Ulrich, MD,*Yvonne Bausback, MD,* Sven Bräunlich, MD,* Henrik Ick, MD,* Johannes Schuster, MD,*Spiridon Botsios, MD,* Hans-Joachim Kruse, MD,† Ramon L. Varcoe, MD,‡ Dierk Scheinert, MD*
Leipzig and Zschopau, Germany; and Sydney, Australia
Objectives The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of longinfrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result.
Background Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at3 months after standard balloon angioplasty was demonstrated.
Methods Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minne-apolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis,and further clinical assessment was performed over a 12-month period thereafter.
Results In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Meanlesion length of the arteries treated was 176 ! 88 mm. Angiography studied in 84 treated arteries at 3 monthsshowed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) andusually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segmentrestenosed or reoccluded. During a follow-up period of 378 ! 65 days, 1 patient was lost and 17 died. Of the91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healingoccurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for pa-tients with critical limb ischemia.
Conclusions The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBscompared with historical data using uncoated balloons. Randomized trials are required to show whether thisdifference will lead to improvement in clinical outcomes. (J Am Coll Cardiol 2011;58:1105–9) © 2011 by theAmerican College of Cardiology Foundation
Percutaneous transluminal angioplasty (PTA) is increas-ingly used to treat infrapopliteal arterial disease. However,the high restenosis rate is problematic, and repeat interven-tions may be required in a significant proportion of patientsto achieve clinical goals (1,2). Drug-eluting stents have beendemonstrated to be effective in lowering the restenosis ratebelow the knee (BTK) (3). Their design for coronaryarteries makes them a practical option more suited toshorter tibial lesions. For long-segment BTK disease, drug-eluting balloons (DEBs) have been designed to reduce the
restenosis rate. Initially emerging as a new treatment optionfor coronary arteries (4), they also have been studied in thefemoropopliteal segment (5,6). In our registry, we aimed toinvestigate a recently approved DEB for its application ininfrapopliteal arteries.
See page 1110
Methods
Patient selection and interventional technique. Con-secutive patients with critical limb ischemia (CLI) or severeclaudication and BTK lesions (stenosis: !70% or occlu-sions) with a lesion length of 80 mm or more were treatedwith a paclitaxel-eluting balloon (In.Pact Amphirion,Medtronic, Minneapolis, Minnesota). The balloon is coatedwith FreePac, a proprietary formulation of 3.0 "g paclitaxel/mm2 and urea, which serves as a hydrophilic spacer to
From the *Center of Vascular Medicine, Angiology and Vascular Surgery, ParkHospital Leipzig, Leipzig, Germany; †Outpatient Facility for Vascular DiseasesZschopau, Zschopau, Germany; and the ‡Department of Surgery, Prince of WalesHospital and University of New South Wales, Sydney, Australia. Drs. Schmidt andScheinert are consultants for Medtronic. All other authors have reported that theyhave no relationships relevant to the contents of this paper to disclose.
Manuscript received February 14, 2011; revised manuscript received May 17, 2011,accepted May 24, 2011.
Journal of the American College of Cardiology Vol. 58, No. 11, 2011© 2011 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00Published by Elsevier Inc. doi:10.1016/j.jacc.2011.05.034
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facilitate separation and releaseof paclitaxel into the vessel wall.Pre-dilation with an uncoatedballoon was performed to ensurean uncomplicated insertion ofthe DEB into the lesions. TheDEB diameter was 0.5 mmlarger than the uncoated balloonto guarantee contact of the DEBto the arterial wall. DEBs had adiameter of 2.0 to 4.0 mm and alength of 80 to 120 mm. If more
than 1 balloon was used per lesion, overlap of the DEBs was5 mm. Inflation time was at least 1 min. In case offlow-limiting dissection or residual stenosis of more than30%, a prolonged dilation of up to 5 min was performed.Stents were used as bailout for unsatisfactory results. Successwas defined as at least 1 infrapopliteal artery restoration incontinuity to the foot with a residual stenosis of less than30%. Inflow lesions were treated during the same session.Pharmacologic therapy. All patients were taking aspirin100 mg daily. After sheath insertion, 5,000 IU heparin wasadministered. After angioplasty, intra-arterial nitroglycerin200 to 300 !g was administered routinely to resolvevasospasm. Post-intervention dual antiplatelet therapy withaspirin 100 mg and clopidogrel 75 mg once daily was givenat least for 4 weeks and 100 mg aspirin was given dailythereafter.Endpoints. The primary endpoint was the angiographicbinary restenosis. Angiographic follow-up was scheduled 3months after the initial procedure according to our hospitalstandards. Selective angiographies in 2 different projectionswere evaluated by 2 investigators based on visual estimate.Binary restenosis was calculated using a 50% diameterreduction threshold. Clinical outcome was assessed at 3 and12 months after angioplasty. Clinical improvement wasdefined as marked ("50%) reduction of ulcer size or depthor increase of at least 1 Rutherford-Becker category. Am-putations and the necessity for target lesion revasculariza-tion (TLR) or bypass surgery were recorded. This study wasperformed without industry financial support. Data analysiswas performed retrospectively. The registry adhered to therequirements of the local ethics committee, and all patientsgave their written informed consent before the procedure.Statistical analysis. Continuous data are given as mean !SD. Categorical variables are expressed as numbers andpercentage.
Results
Baseline characteristics of patients and lesions. BetweenJanuary 2009 and February 2010, 104 consecutive patientsmeeting the inclusion criteria were studied. In these pa-tients, 109 limbs were treated either for CLI (82.6%) orsevere claudication (17.4%). Patient characteristics are givenin Table 1.
Before treatment, 77.1% of the patients had complete orfunctional occlusion of all 3 infrapopliteal arteries. Meaninfrapopliteal lesion length was 176 ! 88 mm. The numberof arteries treated was left to the discretion of the interven-tionalist; however, in only 5 limbs was more than 1 arterytreated.
The mean number of DEBs used per artery was 1.9(range: 1 to 5). In 28 limbs, a proximal angioplasty (allinfrainguinal) was performed additionally during the sameintervention using uncoated balloons.Peri-procedural outcomes. Interventional success wasachieved in all limbs, and stenting was necessary in 5 cases.Inevitable toe amputation was performed in 3 patients in theperi-interventional period. Complications before dischargeincluded 3 femoral pseudoaneurysms, only 1 requiringsurgical repair. One patient with an infected diabetic footwho was Rutherford-Becker category 6 died as a result of amajor amputation performed 21 days after PTA.3-month follow-up. During this period, 8 additional pa-tients died, 7 of cardiac disease and 1 of a bronchial cancerdiagnosed before PTA. One patient was lost for follow-up.Clinical improvement in the remaining 94 patients was seenin 75.8% of the treated limbs, 22.2% were unchanged, and2.0% were clinically worse. Three additional toe amputa-tions were performed. Complete wound healing was notedin 41.9% of the Rutherford-Becker category 5 limbs.Twenty patients declined to undergo repeat angiography.There was no difference in lesion characteristics or 3-monthclinical outcomes between the patients with or withoutrepeat angiography.Subgroup of angiographically examined patients at3 months. Angiography at 3 months was performed in 74patients with 79 treated limbs and 84 arteries treated withDEBs. Lesion characteristics are given in Table 2. BeforePTA, target arteries were stenosed in 38.1% and wereoccluded in 61.9%. Angioplasty was performed for 55 de
Demographic Patient DataTable 1 Demographic Patient Data
Age (yrs) 73.6 ! 6.7
Male 69 (66.3%)
Arterial hypertension 95 (91.3%)
Diabetes mellitus 74 (71.1%)
Smoking habit 32 (30.8%)
Hypercholesterolemia 68 (65.4%)
Obesity 33 (31.7%)
Coronary artery disease 47 (45.9%)
NYHA functional classes III and IV 23 (22.1%)
Renal insufficiency (GFR "60 ml/min/1.73 m2) 48 (46.2%)
Cerebrovascular disease 19 (18.3%)
Rutherford-Becker category 6 1 (0.9%)
Rutherford-Becker category 5 70 (64.2%)
Rutherford-Becker category 4 19 (17.45%)
Rutherford-Becker category 3 19 (17.45%)
Values are mean ! SD or n (%).GFR # glomerular filtration rate calculated by MDRD formula (Modification of Diet in Renal
Disease); NYHA # New York Heart Association.
Abbreviationsand Acronyms
BTK ! below the knee
CLI ! critical limbischemia
DEB ! drug-eluting balloon
PTA ! percutaneoustransluminal angioplasty
TLR ! target lesionrevascularization
1106 Schmidt et al. JACC Vol. 58, No. 11, 2011Drug-Eluting Balloons for Tibial Arteries September 6, 2011:1105–9
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novo lesions, 19 restenoses, and 10 in-stent restenoses.Mean lesion length was 173 ! 87 mm and mean DEBdiameter was 2.72 ! 0.41 mm. Bailout stenting wasperformed in 5 cases. Cypher stents (Cordis, Miami, Flor-ida) were used in 3 cases, and self-expanding nitinol stents(Maris Deep, Medtronic) were used in 2 cases. Full lesioncoverage was performed in 1 of the cases.
Angiography at 3 months (mean 98 ! 22 days) found 61(72.6%) of 84 arteries free of significant restenosis. In27.4%, a restenosis of more than 50% was found (19.1% hada restenosis and 8.3% were occluded). In most of thesecases (61%), restenosis developed only focally ("20% ofthe length of the initial target lesion) (Fig. 1). Restenosisor reocclusion of the entire target lesion occurred only in8 (9.5%) of the 84 treated arteries. Higher restenosis rateswere seen after treatment of distal segments, especiallywhen foot arteries were involved (Table 2). Two (2.4%)of the 84 treated arteries became ectatic within thetreated segment (less than double of the reference vesseldiameter), and 1 was associated with restenosis. Clinicalimprovement in limbs with restenosis was similar to thatof those without.Midterm clinical follow-up. After a mean follow-up of378 ! 65 days, 86 patients with 91 treated limbs wereevaluated clinically. Clinical improvement occurred in91.2% of these limbs. No bypass surgery was performedduring the entire study period. TLR was performed in17.3%. Limb salvage was achieved in 95.6% of the CLIpatients and complete wound healing occurred in 74.2% ofthe patients with Rutherford-Becker category 5 at baseline.Eight additional patients died, all for unrelated reasons,resulting in a mortality rate of 16.3% at 1 year. There were4 unplanned amputations during this period, 1 single toeamputation, 1 forefoot amputation, and 2 major BTKamputations. The Rutherford-Becker categories of all pa-tients before and after 1 year are shown in Figure 2.
Discussion
The restenosis rate after PTA of infrapopliteal arteries isvery high. In a series recently published treating infrapop-
Location of Angioplasty of Patients Who Underwent3-Month Angiography and Restenosis Rate inRelation to the Treated Artery and Site of theTreated Segment
Table 2
Location of Angioplasty of Patients Who Underwent3-Month Angiography and Restenosis Rate inRelation to the Treated Artery and Site of theTreated Segment
Artery or Site Involved in PTA n (%) Restenosis (%)
Distal popliteal artery 11 (13.1) 1 (9.1)
Anterior tibial artery 48 (57.1) 15 (31.3)
Tibioperoneal trunk 18 (21.4) 3 (16.7)
Posterior tibial artery 16 (19.0) 5 (31.3)
Peroneal artery 18 (21.4) 3 (16.7)
Proximal segment of tibial arteries 54 (64.3) 5 (9.3)
Mid segment of tibial arteries 45 (53.6) 9 (20.0)
Distal segment of tibial arteries 37 (44.0) 7 (18.9)
Arteries distal to the malleolus 13 (15.5) 5 (38.5)
PTA # percutaneous transluminal angioplasty.
Figure 1 Focal Restenosis at 3 Months
(A) Angiographic image showing total occlusion of the anterior tibial artery leftleg (dashed line and arrows). (B) Angiographic image obtained after angio-plasty of the anterior tibial artery with drug-eluting balloons. (C) Angiographicimage obtained after 3 months showing a focal restenosis (arrow).
1107JACC Vol. 58, No. 11, 2011 Schmidt et al.September 6, 2011:1105–9 Drug-Eluting Balloons for Tibial Arteries
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liteal arteries with a mean lesion length of 183 mm withuncoated low-profile balloons, we demonstrated an angio-graphic restenosis rate of 69% at 3 months (2). Because ofthis finding, we selected long BTK lesions for treatmentwith the recently approved infrapopliteal DEB (In.PactAmphirion). The mean lesion length of 173 mm in thisseries is comparable in length with that of our previous study(2). The 3-month restenosis rate of 27% after treatmentwith DEB represents a dramatic reduction for restenosis of61% from the 69% seen in the series using uncoatedballoons (2). In addition, we observed an altered pattern ofrecurrent disease that favored the DEB. Whereas restenosisusually involved the whole treated segment with uncoatedballoons (2), restenosis after DEB was found to be focal,involving !20% of the length of the target lesion in morethan 60% of the restenosed vessels. This pattern of shorterrestenosis may have less impact on flow compared with thediffuse type and also simplifies TLR.
Although our series is too small to perform a meaningfulsubanalysis of factors that may influence patency after PTAwith DEBs, the most distal lesions seem to perform worst. ForDEB angioplasty distal to the malleolus, we found a restenosisrate of 38.5% at 3 months. This is consistent with otherpublished series that recognize standard balloon angioplasty forpedal arteries to be a predictor of limb loss (1). The highrestenosis rate we observed in this region may be a contributingfactor.Safety of DEBs in BTK arteries. We found nothing toindicate the use of DEBs BTK to be unsafe. An amputationrate of 4.4% is very acceptable for CLI patients. During the3-month angiogram, 2 arteries became moderately ectaticwithin the treated segment, which resulted in no adverseclinical events. This has not been described previously forDEBs for other arteries. We do not believe that thisobservation raises concerns regarding the safety of DEBs inthe infrapopliteal circulation.
Clinical results. Multiple factors contribute to wound heal-ing and limb salvage, including local wound care and surveil-lance regimen, which may be equally as important as revascu-larization. It therefore may be difficult to prove the superiorityof the DEBs over uncoated balloons for these clinical end-points. In fact, similar favorable results for wound healing andlimb salvage have been described after plain old balloonangioplasty of long infrapopliteal disease (2,7). TLRs fre-quently are needed after endovascular treatment of BTKarteries (1,2) and therefore may be considered a more usefulclinical endpoint. Compared with the TLR rate of 50% in ourseries using uncoated balloons (2), the use of DEBs resulted ina TLR rate of 17.3%, a considerable reduction of 65.4%. It iswith regard to TLR that the use of DEBs has most potentialto improve clinical outcomes compared with standard balloons.Costs are likely to play an important role for the use of DEB;however, the potential reduction in number of reinterventionsalso must be considered in these calculations if we are tocompare DEBs with uncoated balloons.Study limitations. Quantitative angiography to determinedegree of restenosis in long BTK lesions is technically verychallenging. In practice, however, the visual assessment ofangiography was believed to be significantly more precisethan the alternatives of duplex ultrasound, magnetic reso-nance angiography, or computed tomography angiography.Only 1 DEB, the In.Pact Amphirion, was approved forperipheral artery application in Europe and therefore wasthe only one used during the study period. Other DEBs maylead to differing results in the future.
Conclusions
This first report of the use of DEBs BTK suggests that they aresafe and effective in this arterial region. When compared witha series using uncoated balloons, the data presented heredemonstrate a marked, more than 60% reduction in therestenosis rate at 3 months. In addition, if restenosis occurred,it was associated with a favorable, focal pattern. The 1-yearclinical results are promising and seem to confer a durablebenefit. Further evidence, in the form of randomized con-trolled trials, is required to confirm whether DEBs are superiorto the standard treatment of plain old balloon angioplasty inpatients with CLI from BTK disease.
Reprints requests and correspondence: Dr. Andrej Schmidt,Center of Vascular Medicine, Angiology and Vascular Surgery,Parkkrankenhaus Leipzig, Strümpellstrasse 41, 04289 Leipzig,Germany. E-mail: andrej.schmidt@gmx.de.
REFERENCES
1. Fernandez N, McEnaney R, Marone LK, et al. Predictors of failure and successof tibial interventions for critical limb ischemia. J Vasc Surg 2010;52:834–42.
2. Schmidt A, Ulrich M, Winkler B, et al. Angiographic patency andclinical outcome after balloon-angioplasty for extensive infrapoplitealarterial disease. Catheter Cardiovasc Interv 2010;76:1047–54.
Figure 2 Midterm Clinical Outcome
Bar graph showing Rutherford-Becker categories at baseline and12.5 months of follow-up (FU).
1108 Schmidt et al. JACC Vol. 58, No. 11, 2011Drug-Eluting Balloons for Tibial Arteries September 6, 2011:1105–9
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3. Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstruc-tions. EuroIntervention 2006;2:169–74.
4. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronaryin-stent restenosis with a paclitaxel-coated balloon catheter. N EnglJ Med 2006;355:2113–24.
5. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel toinhibit restenosis during angioplasty of the leg. N Engl J Med2008;358:689–99.
6. Werk M, Langer S, Reinkensmeier B, et al. Inhibition of restenosisin femoropopliteal arteries: paclitaxel-coated versus uncoated bal-
loon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358 – 65.
7. Ferraresi R, Centola M, Ferlini M, et al. Long-term outcomes afterangioplasty of isolated, below-the-knee arteries in diabetic patientswith critical limb ischemia. Eur J Vasc Endovasc Surg 2009;37:336 – 42.
Key Words: critical limb ischemia y drug-eluting balloons y restenosisy tibial arteries.
1109JACC Vol. 58, No. 11, 2011 Schmidt et al.September 6, 2011:1105–9 Drug-Eluting Balloons for Tibial Arteries
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IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014"
IN.PACT drug eluting balloon superior to PTA in CLI BtK patientsData presented at LINC 2012 by Dr. Liistro, Arezzo, Italy
STUDY PURPOSETo investigate whether DEB can reduce long-term restenosis rate compared to conventional balloon in diabetic patients with CLI undergoing peripheral intervention in tibial vessels.
PRIMARY AND SECONDARY ENDPOINTS - The primary endpoint was 12 months re-stenosis rate- Secondary endpoint: target lesion reocclusion
STUDY METHODS- Investigator sponsored single-center randomized (1:1) trial- Angiographic follow-up at 12 months
PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS
DEBATE BTK
* Randomized Data for the Treatment of Below the Knee Lesions with Drug Eluting Balloons!
Dr. Francesco Liistro Department of Cardiovascular Disease,
San Donato Hospital, 52100 Arezzo, Italy presented at LINC 2012
DEBATE BTK "PRELIMINARY RESULTS#*
DRUG!ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE
DEB (n=60) POBA (n=60)
Age 74±10 76±10
Hypertension 79% 83%
Hypercholesterolemia 25% 25%
Reference Vessel Diameter 2.86mm 2.82mm
Occlusion 80% 82%
Mean Lesion Length 121mm 123mm
BTKCLI/DIABETICS
STATUS DATE: 02/2012
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IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER 0.014”
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Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
CONCLUSION
By preliminary study results, DEB seem to provide better results in terms of 12 months restenosis and reocclusion compared to POBA in the revascularization of tibial vessels in diabetic patients with CLI.
DEBATE BTK "PRELIMINARY RESULTS#*
IN.PACT drug eluting balloon superior to PTA in CLI BtK patients
12 MONTHS RESULTS !ANGIOGRAPHIC AND CLINICAL"
DEB (n=60) POBA (n=60) P value
Death 6% 4% 0.2
Major Amputation 0 1
12 months restenosis 29% 72% 0.0004
12 months reocclusion 14% 50% 0.0006
70% –
60% –
50% –
40% –
30% –
20% –
10% –
0% –Re-stenosis Re-occlusion
DEB
POBA
BTKCLI/DIABETICS
72.0%
50.0%
14.0%
29.0%
p=0.0004
p=0.0006
STATUS DATE: 02/2012
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IN.PACT DEB TECHNOLOGY
CLINICAL TRIAL OVERVIEW
SFA RESULTS
BTK RESULTS
IN.PACT DEB Technology andClinical Evidence
ORDER INFORMATION
& ABBREVATIONS
Order Information
Abbreviations
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ORDERINFORMATION
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ORDER INFORMATION
Ref. N° 80 cm shaft length
Ref. N° 130 cm shaft length
Balloon diameter
(mm)
Balloon length (mm)
Recom. introducer sheath (F)
RBP (bar)
SBI 040 040 08P SBI 040 040 13P 4 40 5 18SBI 040 060 08P SBI 040 060 13P 4 60 5 18SBI 040 080 08P SBI 040 080 13P 4 80 5 18SBI 040 120 08P SBI 040 120 13P 4 120 5 18SBI 050 040 08P SBI 050 040 13P 5 40 6 17SBI 050 060 08P SBI 050 060 13P 5 60 6 17SBI 050 080 08P SBI 050 080 13P 5 80 6 15SBI 050 120 08P SBI 050 120 13P 5 120 6 15SBI 060 040 08P SBI 060 040 13P 6 40 6 17SBI 060 060 08P SBI 060 060 13P 6 60 6 17SBI 060 080 08P SBI 060 080 13P 6 80 6 15SBI 060 120 08P SBI 060 120 13P 6 120 6 15SBI 070 040 08P SBI 070 040 13P 7 40 6 16SBI 070 060 08P SBI 070 060 13P 7 60 6 14SBI 070 080 08P SBI 070 080 13P 7 80 6 14
Ref N°90 cm shaft length
Ref N° 130 cm shaft length
Balloon diameter
(mm)
Balloon length(mm)
Recom. Introducer sheath (F)
RBP (bar)
PCF 040 040 09P PCF 040 040 13P 4.00 40 5 20PCF 040 060 09P PCF 040 060 13P 4.00 60 5 14PCF 040 080 09P PCF 040 080 13P 4.00 80 5 14PCF 040 120 09P PCF 040 120 13P 4.00 120 5 14PCF 050 040 09P PCF 050 040 13P 5.00 40 5 20PCF 050 060 09P PCF 050 060 13P 5.00 60 5 14PCF 050 080 09P PCF 050 080 13P 5.00 80 5 14PCF 050 120 09P PCF 050 120 13P 5.00 120 5 14PCF 060 040 09P PCF 060 040 13P 6.00 40 5 16PCF 060 060 09P PCF 060 060 13P 6.00 60 5 14PCF 060 080 09P PCF 060 080 13P 6.00 80 5 14PCF 060 120 09P PCF 060 120 13P 6.00 120 5 14PCF 070 040 09P PCF 070 040 13P 7.00 40 6 12PCF 070 060 09P PCF 070 060 13P 7.00 60 6 12PCF 070 080 09P PCF 070 080 13P 7.00 80 6 12PCF 070 120 09P PCF 070 120 13P 7.00 120 6 12
Ref. N° 120 cm shaft length
Ref. N° 150 cm shaft length
Balloon diameter
(mm)
Balloon length (mm)
Recom. Introducer sheath (F)
RBP(bar)
AMD 020 040 00P AMD 020 040 15P 2.00 40 4 15AMD 020 080 00P AMD 020 080 15P 2.00 80 4 14AMD 020 120 00P AMD 020 120 15P 2.00 120 4 14AMD 025 040 00P AMD 025 040 15P 2.50 40 4 16AMD 025 080 00P AMD 025 080 15P 2.50 80 4 15AMD 025 120 00P AMD 025 120 15P 2.50 120 4 14AMD 030 040 00P AMD 030 040 15P 3.00 40 4 16AMD 030 080 00P AMD 030 080 15P 3.00 80 4 15AMD 030 120 00P AMD 030 120 15P 3.00 120 4 14AMD 035 040 00P AMD 035 040 15P 3.50 40 4 16AMD 035 080 00P AMD 035 080 15P 3.50 80 4 15AMD 035 120 00P AMD 035 120 15P 3.50 120 4 14AMD 040 040 00P AMD 040 040 15P 4.00 40 4 16AMD 040 080 00P AMD 040 080 15P 4.00 80 4 15AMD 040 120 00P AMD 040 120 15P 4.00 120 4 14
IN.PACT AdmiralPACLITAXEL!ELUTING PTA BALLOON CATHETER OTW 0.035"
IN.PACT PacificPACLITAXEL!ELUTING PTA BALLOON CATHETER OTW 0.018"
IN.PACT AmphirionPACLITAXEL!ELUTING PTA BALLOON CATHETER OTW 0.014"
Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com
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ABBREVIATIONS
ABI Ankle Brachial Index
BTK Below The Knee
DEB Drug Eluting Balloon
DS Diameter stenosis
GFR Glomerular Filtration Rate
ITT Intention To Treat
LLL Late Lumen Loss = MLD (at follow up) - MLD (post-procedure)
MACE Major Adverse Clinical Effects
MLD Minimum Luminal Diameter
PP Per Protocol
PSVR Peak Systolic Velocity Ratio
PTA Percutanous Transluminal Angioplasty
RC Rutherford Classification
RR Restenosis Rate Binary Restenosis= DS > 50% of treated lesion at follow-up
RVD Reference Vessel Diameter
SFA Superficial Femoral Artery
TLR Target Lesion Revascularization
TVR Target Vessel Revascularization
US Ultrasound
USCD Ultrasound Color Doppler
Global HeadquartersHungerbüelstrasse 128500 Frauenfeld – Switzerland
www.medtronic.comwww.invatec.com