Is there still any space left for DES in the BTK area??? (Angiolite BTK trial, 6 month Data)
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1 Is there still any space left for DES in the BTK area??? (Angiolite BTK trial, 6 month Data) (Angiolite BTK DES, IVascular) P. Goverde MD, K. Taeymans MD, K. Lauwers MD Vascular Clinic ZNA Antwerp,Belgium
2 Disclosure Speaker s name: Peter Goverde I have the following potential conflicts of interest to report: Grant/Research Support/Consulting Fees/Honoraria: Abbott Vascular; Angioslide; Bard Peripheral Vascular; Bentley; B Braun endovascular; Cardionovum; Cordis Cardinal Health; CTI; IMDS; Ivascular; Getinge group; Stille; Ziehm Imaging
3 Major goal : prevention
4 Endo treatment strategy BTK Successful recanalization long diffuse POBA DCB? short focal / Medium DES Recoil/dissection/ intraluminal cacification Re-POBA Recoil/dissection Mission accomplished Bail out stenting BTK SX stent + prior DCB? 4
5 Angiolite BTK safety and feasibility study Safety & feasibility study with IVascular Angiolite BTK BX DES as bail out in BTK procedures Start Aug 2016 Single center, physician initiated, prospective, real-life nonrct N= 50 patients Rutherford-Becker : 4-5-6
6 Angiolite BTK safety and feasibility study A. Primary Endpoint 1. Safety & feasibility using IVascular Angiolite BTK BX DES in BTK bail out procedures 2. Absence of clinically driven target lesion 12 months. B. Secondary Endpoints (1/2) 1.Technical success defined as a successful access and deployment of the device and determined by less than 30 % residual stenosis by angiography at the baseline procedure. 2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure
7 Angiolite BTK safety and feasibility study B. Secondary Endpoints (2/2) 3. Primary and secondary patency rate (if duplex ultrasound available) defined as < 50 % diameter reduction and peak systolic velocity < 2.4 at 12 months 4. Ankle-Brachial Index improvement of 0.1 (ABI before procedure compared with ABI at 1,6,9 & 12 months). 5. Clinically driven Target Vessel Revascularization at 6, 9 and 12 months. 6. Major complications at 6,9 and 12 months, including amputation of a part of the foot, the leg below and above the knee. 7. The Rutherford-Becker classification of chronic limb ischemia at 1, 6, 9 and 12 months post procedure.
8 Exclusive stent design for DES angiolite Sirolimus eluting stent
9 STENT MATERIAL WALL THICKNESS STENT CHARACTERISTICS CoCr L microns for stent 2 to 2.5mm 80 microns for stent 2.75 to 3.5mm 85 microns for stent 4 to 4.5mm % RECOIL < 5% % FORESHORTENING < 3% % SURFACE IN CONTACT WITH ARTERY 10-20% VESSEL CONFORMABILITY DRUG DRUG COATING FEATURES High Sirolimus DRUG DOSE 1,4 µg/mm 2 POLYMER Biostable
10 SYSTEM DIMENSIONS Working length of the catheter 142 cm Catheter shaft (diameter) 2F Proximal 2.6F Middle 2.2F Distal Distance guidewire entry to tip 25 cm Entry profile Recommended guidewire inch inch
11 CHARACTERISTICS OF THE STENT PRE-MOUNTED ON BALLOON MATERIAL Nylon and Pebax. Final product without latex components BALLOON Semi-compliant NOMINAL PRESSURE 9-12 atm RATED BURST PRESSURE (RBP) 16 atm AVERAGE BURST PRESSURE (ABP) 22 atm STENT CROSSING PROFILE (at max. length of the stent) Diameter (mm) INCHES mm-french RADIOPAQUE MARKERS 2 metallic markers on the catheter delimiting the stent GUIDING CATHETER COMPATIBILITY 5F
12 STENT LENGTHS (mm) Angiolite BTK : Portfolio of 63 different stents STENT DIAMETERS (mm) X X X X X X X 14 X X X X X X X X 16 X X X X X X X X 19 X X X X X X X X 24 X X X X X X X X 29 X X X X X X X X 34 X X X X X X X X 39 X X X X X X X X
13 77 y man Diabetes type1 AHT AMI/PTCA/CABG Hypercholesterolemia 5 PTAs fempop region Rutherford Becker 5 Ulcers D1/D3/D5 case
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26 Angiolite BTK safety and feasibility study Baseline Patient Demographics : n = 50 Male Gender 35 Mean Age 71.1 Mean BMI 31.7 Nicotine abuse (present&past) (%) 88 Hypertension (%) 84 Hypercholesterolemia (%) 56 Diabetes (type 1=2) (%) 72 Vascular History (%) 48 Recurrent disease (%) 34 Coronary History (%) 58 Cerebrovascular History (%) 22 Renal insufficiency (%) 58
27 Angiolite BTK safety and feasibility study Rutherford Beccker LESION LOCATION N = 64 Tibioperoneal Trunc 24 Anterior Tibial Artery 16 Peroneal Artery 15 Posterior Tibial Artery 9
28 Angiolite BTK safety and feasibility study : ABI Grade ABI Ankle systolic pressure N 0 >0.80 >100 mm Hg mm Hg mm Hg 11 3 <0.39 <50 mm Hg 33 (WIfI) (J Vasc Surg 2014;59: )
29 Angiolite BTK safety and feasibility study Procedure (1/3) Vessel preparation Mean lesion length Reference vessel diameter Predilatation/balloonangioplasty 49 Primary stenting mm 3.43 mm Mean stenosis before treatment % Number of occlusions 52% Presence Moderate to heavy calcifications 78% Use of Drug Coated Balloon (mainly for distal vessel treatment) 34%
30 Angiolite BTK safety and feasibility study Procedure (2/3) Stents used 68 Tibioperoneal trunc 24 Anterior Tibial artery 18 Peroneal Artery Posterior Tibial Artery Mean stent diameter Mean stent length mm 32.1 mm Number stents / patient 1,
31 Procedure (3/3) Angiolite BTK safety and feasibility study N Access site ipsilateral 43 cross-over 7 Mean residual stenosis at end of procedure (%) 18.5% Mean Heparine (IU) 6250IU Mean contrast 94.5 ml Patients + CO² angio 26 Access hemostasis closure device 47/50 Technical success (<30% diameter residual Stenosis) 100
32 Angiolite BTK safety and feasibility study Post procedure : aspirin (for life) + clopidogrel (min 6 mo) Anticoagulation or NOAC + clopidogrel (6 mo) Follow-up : 1,3,6,9,12 (18,24, 36) months ultrasound 2-14months Death : 3 D41 : AMI D87 : sepsis/mof D135 : cardiovascular
33 1)PEDIS Classification Definition The PEDIS classification is a faceted classification that provides a taxonomy for classifying lesions in patients with diabetic foot syndrome. Every lesion is described according to the following scheme: Perfusion Grade 1: no symptoms/signs of PAD Grade 2: symptoms or signs of PAD, but not CLI Grade 3: CLI Extent/size (cm²) Depth/tissue loss Angiolite BTK safety and feasibility study: wound follow-up Grade 1: Superficial full-thickness ulcer Grade 2: Ulcer penetrating below dermis to skin structures Grade 3: All subsequent layers of foot, including bone/joint
34 PEDIS Classification Infection Grade 1: no symptoms/signs Grade 2: Inflammation of skin/sc only Grade 3: Extensive erythema deeper than skin/sc Grade 4: Systemic inflammatory response syndrome (SIRS) Sensation Grade 1: No loss of protective sensation Grade 2: Loss of protective sensation Example: P2E1D2I1S2. Angiolite BTK safety and feasibility study: wound follow-up
35 PEDIS Classification PEDIS Pre-intervention : P: 3 E: 5.2 D: 2.41 I: 2.63 S: 1.73 PEDIS 30 days : Angiolite BTK safety and feasibility study: wound follow-up : 30 days P: 1.37 E: 2.13 D: 1.32 I: 0.83 S: 0.49
36 Angiolite BTK safety and feasibility study: wound follow-up The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: Risk stratification based on Wound, Ischemia, and foot Infection (WIfI) (J Vasc Surg 2014;59: ) Grade Pre-intervention 30 days Wound Ischemia Foot Infection
37 Angiolite BTK safety and feasibility study (preliminary %) 30 days 6 Mo 9 Mo 12 Mo 18 Mo Primary Patency 100 % 88% Secunadary Patency 100 % 96% Freedom TLR 100 % 94% Freedom of major amputation 98 % 94% Freedom Minor amputation 77.6% 72 %
38 After 2 weeks Vacuum therapy After 5 weeks
39 After 7 weeks
40 Conclusions Use of Angiolite BTK is safe and feasible Follow-up needs to confirm advantages Positive effect on revascularization/wound healing Further follow-up is needed
41 Thank You for your attention
42 Is there still any space left for DES in the BTK area??? (Angiolite BTK trial, 6 month Data) (Angiolite BTK DES, IVascular) P. Goverde MD, K. Taeymans MD, K. Lauwers MD Vascular Clinic ZNA Antwerp,Belgium
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