The LIMBO trial: a RCT investigating adventitial dexamethasone infusion to prevent restenosis in BTK arteries utilizing a novel angiographic endpoint
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1 The LIMBO trial: a RCT investigating adventitial dexamethasone infusion to prevent restenosis in BTK arteries utilizing a novel angiographic endpoint Dr. Ulrich Beschorner Universitäts Herzzentrum Freiburg Bad Krozingen 1
2 Disclosure Speaker name: Ulrich Beschorner... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 The Bullfrog Micro-Infusion Device (Mercator MedSystems) 20% contrast 80% dexamethasone 3
4 Interrupting the Cascade at Inflammation Cell recruitment ATVB 2011;31: Inflammation cytokine expression Proliferation Neointima Lumen Loss 4
5 Background Data from DANCE (Adventitial DEX in SFA/Pop) Interim: 73 DANCE Atherectomy Subjects Rutherford % Rutherford % Rutherford % Severe Calcification 26.6% Popliteal Involvement 20.5% TASC II Classification 36% A; 59% B; 6% C Restenosis 8.2% Lesion Length (cm) 8.8 ± 5.2 %DS (Pre) 69% ± 17% Total Occlusions 15.4% Grade B-D Dissection 25.0% Stent Utilization 34.2% Safety (0-360 Days) Device-related SAE 0/83 (0%) Drug-related SAE 0/83 (0%) Major Adverse Limb Events Amputation Bypass Thrombolysis 0/83 (0%) 2/83 (2.4%) 0/83 (0%) Death 0-30 Days 0/97 (0%) Death Days 5/88 (5.7%) Efficacy TLR at 360 Days 8.3% Patency at 360 Days 85.0% TLR at 390 Days 8.8% %DS (Post) 20% ± 7% Patency at 390 Days 81.5% 5
6 LIMBO Trial Design Below-Knee 2 trials: Adventitial Dexamethasone added to PTA (Germany) or atherectomy (U.S.) Anticipated start: Q LIMBO-PTA PI: Dierk Scheinert, MD, University Hospital Leipzig, Germany LIMBO-ATX copis: George Adams, MD, UNC-Rex, Raleigh, NC Don Jacobs, MD, St. Louis University, MO LIMBO-ATX Baseline angiogram and biomarker blood draw 60 controls LIMBO-PTA 120 ATX (U.S.) 120 PTA (Germany) 60 DEX 60 controls 60 DEX 24-hour blood draw for biomarkers 1-month blood draw for biomarkers Clinical, hemodynamic and angiographic follow-up at 6 months 6
7 Gold-Standard Vascular Patency Endpoints in BTK Duplex Ultrasound (DUS) vs Digital Subtraction Angiography (DSA) SFA and popliteal Good agreement between DUS and DSA Good technical success of DUS Good technical success of DSA Infrapopliteal Moderate agreement between DUS and DSA Poor technical success of DUS Moderate technical success of DSA Eiberg et al. Eur J Vasc Endovasc Surg (2010) 40,
8 Not All Restenosis is Equal In long lesions, standard measures of patency do not account for focal vs. diffuse restenosis FOCAL RESTENOSIS Greater late lumen loss Greater angiographic restenosis Greater PSVR DIFFUSE RESTENOSIS Greater reduction in blood flow to foot How do we show the difference between this and this numerically with a clinically meaningful endpoint? 8
9 What is Patency in BTK Disease? Run-off to the foot Perfusion of wounds or ischemic tissues Improvement in blood flow (reduction of flow resistance) Flow resistance is proportionate to Inverse of diameter (to the 4 th power) Length (to the 1 st power) Viscosity (to the 1 st power) - unchanging 9
10 Opportunity for Improvement in BTK Patency Assessment LLL provides a measure of a single cross-section of the vessel (at the minimal lumen diameter) %DS (percent diameter stenosis) describes flow constriction, but also only at a single cross-section How can we measure blood flow resistance over the entire lesion length? distal proximal % Diameter Stenosis 10
11 Novel LIMBO Endpoint - TVAL TVAL: Transverse-view Vessel Area Loss A measurement of AREA opacified by contrast, rather than the narrowest cross-section, which LLL defines BASELINE FOLLOW-UP MLD baseline TL TL TVA baseline TVA f/u MLD follow-up LLL = MLD baseline MLD follow-up (in mm) TVA = shaded area within TL end constraints (in mm 2 ) TVAL = 100% - (TVA f/u / TVA baseline ) Courtesy of Kirk Seward, PhD, Mercator MedSystems 11
12 TVAL Example FINAL MLD F/U MLD FINAL MLD F/U MLD Area: mm2 Area: mm2 (mm) p o d r (mm) (mm) TVA = shaded area within TL end constraints (in mm2) TVAL = 100% - (TVA f/u / TVA baseline ) TVAL = 100% - ( / ) TVAL = 100% - (76%) TVAL = 24% LLL = MLD baseline MLD follow-up (in mm) LLL = LLL = 2.40 Possible restenosis, but unclear extent Recognition of diffuse low-grade stenosis or focal restenosis o p d r (mm) 12
13 Conclusion Angiographic follow-up is more informative than duplex ultrasound in BTK lesions TVAL provides a new measure that is potentially more informative of the condition of the vessel than LLL 13
14 Acknowledgements Definition of TVAL: Kirk Seward, PhD, Mercator MedSystems Prof. Dierk Scheinert, MD, Universitaet Leipzig George Adams, MD, University of North Carolina, Rex Hospital TVAL measurements: Cardiovascular Research Foundation, New York, NY, USA Philippe Genereux, MD, Director Bad Krozingen CoreLab, Germany Ulrich Beschorner, MD, Director 14
15 The LIMBO trial: a RCT investigating adventitial dexamethasone infusion to prevent restenosis in BTK arteries utilizing a novel angiographic endpoint Dr. Ulrich Beschorner Universitäts Herzzentrum Freiburg Bad Krozingen 15
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