4/14/2016. Faculty Disclosure. Drug-eluting technology in the SFA and Popliteal. Typical SFA Disease Pattern. Why Peripheral Artery Disease Matters

Transcription

1 Drug-eluting technology in the SFA and Popliteal David Paul Slovut, MD, PhD Associate Professor of Medicine and Surgery Co-director of TAVR program Director of Advanced Intervention Faculty Disclosure David Paul Slovut, MD, PhD No financial relationships to disclose Why Peripheral Artery Disease Matters PAD is associated with Functional decline Decreased QoL Increased anxiety and depression Limb loss Increase CV morbidity and mortality Typical SFA Disease Pattern SFA Endovascular Options Restenosis the Bane of SFA Intervention Scoring/cutting balloons Atherectomy Stent/Stent grafts DEB Drug-coated stents 1

2 SFA Restenosis Rates Forces on the SFA Forces Exerted on the SFA Extension / Contraction Flexion Torsion Compression Stent Fracture Scheinert D et al. J Am Coll Cardiol. 2005;45: Stent architecture Flexibility Adaptability Stent length Stent implant technique Elongation Overlapping stents Strut Fracture Component Separation Device Failure SFA Endovascular Options Strut Fracture Scoring/cutting balloons Atherectomy Stent/Stent grafts Component Separation DEB Drug-coated stents 2

3 DCB Conceptual Advantage Proven class effect Drug delivery to deep layers after single contact (dependent on good carrier) No permanent implantable prosthesis Avoids constant irritating external force and possible Take only memories associated ISR Avoid DAPT Acceptable safety profile More comparative data required Paclitaxil Inhibits cellular replication Plasma level x less than those with chemo Inhibits proliferation and migration of vascular SMCs DCB Mechanism THUNDER Trial Tepe G et al. NEJM 2008;358: Randomized, multicenter trial of 154 pts w fem-pop disease Variable PTXcoated Uncoated PTX in contrast P value Late loss 6 mos TVR 6 months 4% 37% 29% TVR 24 months 15% 52% 40% FemPac Trial Werk M. et al. Circulation 2008;118: Time to 1st TLR or 1st Major Amputation PAC CNTRL In.Pact SFA Trial Laird JR et al. J Am Coll Cardiol 2015;66: RCT comparing vs DCB for SFA lesions up to 18 cm in length 331 patients with claudication or rest pain 24-month assessment Primary patency Freedom from clinically driven TLR Major adverse events Quality of life 3

4 In.Pact SFA Trial Laird JR et al. J Am Coll Cardiol 2015;66: DCB Trials in SFA: 6 Month Mean Late Lumen Loss p=0.016 p=0.001 p= N=39 N=35 N=41 N=48 N=31 N=34 LEVANT I THUNDER 1 FemPac 2 In.Pact SFA Trial Laird JR et al. J Am Coll Cardiol 2015;66: Outcome Baseline 24 Month Baseline 24 Month 6 min walk Walking Impairment Qs Walking impairment Walking distance Walking speed Stair climbing What About Stents? Ideal lesion for infrainguinal intervention is focal (<10cm) Stents improve initial and short-term results Stent fractures contribute to poor outcomes Covered stents do not perform better than uncovered stents Unique anatomical features of SFA present significant impediment to stent design Zilver PTX Nitinol stent Outer surface coated with PTX 3 μg/mm 2 No polymer or binder Patients with symptomatic fem-pop disease randomized to DES (n=236) or (n=238) Mean age 68 years old, 65% male 91% claudicants 1-year primary endpoints Event-free survival Primary patency Uncoated Paclitaxel Coated 4

5 PRIMARY PATENCY 4/14/2016 Variable group (n=238) DES group (n=236) P value Claudication (%) Lesion location SFA (%) SFA/pop or popliteal (%) 8 7 Occlusion (%) Lesion length (mm) Percent stenosis Calcification (mod-severe, %) Zilver PTX Subgroup Analysis SFA Stent Patency: Contemporary Trials Primary Patency LESION LENGTH, CM SFA Stent Patency: Contemporary Trials Study Stent n Lesion Length (cm) CTO (%) Freedom from TLR 12 M Primary Patency Leipzig SUPERA 107* Zilver Trial Zilver PTX Sirocco II SMART (DES) ** Resilient LifeStent Saxon Viabahn Durability Everflex FAST Luminexx Super-SL SMART Vienna Absolute Vibrant BMS Arm

6 FAIR Trial Krankenberg H et al. Circ 2015;132: FAIR Trial Krankenberg H et al. Circ 2015;132: Patients with in-stent restenosis (n=119) Plain old balloon angioplasty vs DCB Primary study end point binary recurrent ISR at 6 months assessed by DUS Mean lesion length 8 cm 33% of lesions occluded 25% of lesion heavily calcified Infrapopliteal: IN.PACT DEEP Zeller T et al. J Am Coll Cardiol 2014;64: Infrapopliteal: IN.PACT DEEP Zeller T et al. J Am Coll Cardiol 2014;64: Multi-center RCT for 358 CLI patients Two endpoints Clinically driven TLR Late lumen loss Infrapopliteal: IN.PACT DEEP Zeller T et al. J Am Coll Cardiol 2014;64: Bioabsorbable Stents Biodegradable polymer poly-(l-lactide) Multiple small trials CFA/SFA (Espirit I, GAIA, REMEDY) Below-knee (AMS INSIGHT, BEST-BTK) At 6 months Primary patency 78% Clinical improvement 72% TLR 18% 6