The drug-eluting balloon superficial femoral artery-long study THE DEB SFA-LONG STUDY Safety and efficacy of the Drug Eluting Balloon (DEB) for the treatment of the Superficial Femoral Artery (SFA) ischemic vascular disease in symptomatic patients presenting with long lesions: a pilot study Antonio Micari - GVM Care&Research - Maria Cecilia Hospital- Cotignola (RA) Italy
Potential conflicts of interest Speaker's name: Antonio Micari I have the following potential conflicts of interest to report: Consultant: Medtronic, Speaker s Burreaus: Boston, Terumo,Bard Institutional grant/ Research support: Medtronic
Background Long (SFA) steno-occlusion is a common condition prone to a high rate of restenosis, reaching 60% at one year for lesion longer than 15 cm The encouraging results obtained with drug- eluting balloons (DEB) in mid-short lesions may not directly be extended to long lesions Considering that long SFA lesions represent the majority of real world lower extremities artery disease population there is a clear need to assess the potential usefulness of DEB technology in this context
Hypothesis Drug-Eluting Balloons reduce femoro-popliteal restenosis as alternative to Stenting for the treatment of long femoro-popliteal arterial disease in patients with claudication and rest pain IN.PACT ADMIRAL - Medtronic Paclitaxel Molecule Urea Spacer Molecule OTW / 0.035 gw compatible 4.0 7.0 mm balloon diameter range 40, 60, 80, 120, 150 mm balloon lengths Freepac Proprietary hydrophilic drug coating formulation LINC 2012-4
Inclusion/Exclusion Criteria The DEB SFA-LONG Stu Key Inclusions RC 2-3-4 Reference vessel diameter 3-7 mm Lesions and/or occlusions > 15 cm 1 crural vessel run-off either pre-existing or successfully established Adequate in-flow Written informed consent Key Exclusions In Stent restenosis Aneurism in the target vessel Acute thrombus in the target limb Failure to cross the Target Lesion with a guide wire Use of alternative therapies (e.g. atherectomy, cutting balloon, laser, radiation therapy, cryoplasty, )
The DEB SFA-LONG study Endpoints Primary endpoint: The rate of primary patency within 12 month post index procedure. o Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and >50% restenosis in the treated lesion. o Clinically driven TLR is defined as any re-intervention within the target lesion due to symptoms or drop of ABI of 20% or >0.15 when compared to post-procedure. o Restenosis > 50% is defined by a peak systolic velocity ratio (PSVR) > 2.4
PSV Ratio PSV stenosis / PSV pre-stenosis 410 / 85 = 4.8 Within CRITICAL STENOSIS Turbolence post Pre
The DEB SFA-LONG study Endpoints Main secondary endpoints: the composite of all Major Adverse Events (MAE) through 24 months i.e. the first occurrence of any of the following: death from any cause, major target limb amputation, thrombosis at the target lesion site Non-target lesion target vessel revascularization The incidence of MAE individual components through 24 months Clinical improvement as assessed by Rutherford Class changes at 6, 12 and 24 months with respect to baseline
Methodology The DEB SFA-LONG Stu D U S D U S D U S Procedure Discharge 1 MFU 6 MFU 12 MFU 24 MFU MAJOR ADVERSE EVENTS/SERIOUS ADVERSE EVENTS Independent adjudication by Angiographic and Duplex Core Labs, Clinical Event Committee Data Monitoring with 100% source data verification
Study organization Sponsor: ES Health Science Foundation (ESREFO) Clinical Research Unit ESREFO: study organization and local support Coordinating PI: periodic investigators meetings and DUS training CRO: Mediolanum Cardio Research e-crf Data management & statistics Corelab DUS: The DEB SFA-LONG study
6 Involved sites The DEB SFA-LONG study E. Brscic Torino N. 7 C. Grattoni Cotignola N. = 22 A. Marchese Bari N. =3 P. Pantaleo Rapallo N. 5 A. Liso Lecce N. 34 A. Micari Palermo N: 34
Enrolment and FU The DEB SFA-LONG stu 110 100 90 80 70 Monthly TOTAL TOTAL 12 M Follow-up Cumulative 12M 85 82 82 77 72 68 68 88 93 100 105 67 69 71 76 80 81 84 86 97 98 60 50 40 36 45 51 57 38 42 50 56 30 25 27 21 26 20 10 4 9 13 2 5 14 0 19 months enrolment period 98% FU completion rate at 12 months
PATIENTS DISPOSITION INCLUDED = 105 1 Month FU N=105 6 Month FU N. = 104 Death: 1 12 Month FU N. = 100 Death: 3 Withdrawal of consent: 1 DUS performed = 90 (89% PP population)
The DEB SFA-LONG study PATIENTS CHARACTERISTICS CHARACTERISTIC N= 105 Age (mean ± SD) 68.03 (±9.26) Male sex (%) 82% Diabetes (%) 57.2% Hypertension (%) 88.6% RESULTS WILL BE Hypercholesterolemia (%) 78.1% PRESENTED IN ROOM 243 Coronary artery disease (%) 55.2% SESSION 14:40 Carotid artery disease (%) 27.6% Previous peripheral revascularization (%) 47.6% Previous SFA revascularization (%) 38% Total lesion lenght (mm) 251.71 (±78.89)
Lesson learned Standardization of DUS The DEB SFA-LONG study
The DEB SFA-LONG study Lesson learned Critical role of the Clinical Research Unit