Disclosures. In-Stent Restenosis: The Tail IS Wagging the Dog 4/15/2016. Restenosis: The Continuing Challenge for Peripheral Vascular Intervention

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1 In-Stent Restenosis: The Tail IS Wagging the Dog Disclosures NONE Michael S. Conte MD Division of Vascular and Endovascular Surgery UCSF Heart and Vascular Center UCSF Vascular Symposium 2016 IF YOU WERE A PAD PATIENT: PAYOR What is the minimum efficacy threshold you would accept for an invasive treatment strategy for life-style limiting claudication? 1. >50% likelihood of improvement for at least one year 2. >50% likelihood of improvement for at least two years 3. >50% likelihood of improvement for at least three years Restenosis: The Continuing Challenge for Peripheral Vascular Intervention Most severe in the infrainguinal vessels Limited Current Strategies Cutting balloons Covered stents Brachytherapy Atherectomy Drug-eluting stents, balloons Promising data in early studies Gene and cell-based therapies Remains the greatest unmet need in Vascular Intervention 1

2 Risk Factors for Restenosis Female gender Long-segment disease (>15 cm) Small caliber artery ( 5 mm) Extensive calcification Stent fracture Poor runoff Systemic inflammation (e.g. elevated hscrp) Diabetes (?) Strongest Predictors of Endovascular Treatment Failure in PAD POOR SELECTION OVERUTILIZATION OF INTERVENTIONS- ESPECIALLY IN CLAUDICATION Improving Technology for PVI Relevant in 2015?? TASC A-Endo Rx of choice TASC D- Surgery Rx of choice TASC B- Endo preferred TASC C- Surgery preferred Needed to address current limitations Atherosclerotic burden, calcification High rates of restenosis High prevalence of permanent implants; challenges of ISR Evolution of Balloon Angioplasty for PVI Improve lumen gain Reduce dissection Reduce Restenosis rates Improvements in stents for femoropopliteal disease Drug elution to reduce restenosis Woven nitinol design to increase flexibility and reduce fracture in highly mobile vessels 2

3 Improving Technology for SFA Disease Options for TASC C/D SFA Disease BMS DCB DES Zilver PTX STRIDES **SIROCCO II **SIROCCO I **PACIFIER **Fempac **Thunder ASTRON FAST ABSOLUTE Super Resilient Durability II Durability I p=.001 no contol p=.491 p=.227 p=.01 p=.035 p=.01 Control p=.028 Intervention p=.377 p=.01 p=.84 no control p=.0001 Lesions in the Regulatory Trials Generally no contol <10 cm (TASC A/B) Estimated 2-yr Patency (%) CLAUDICATION POBA MATH for Bilateral TASC C/D Disease: Endo patency PTA+ BMS 1 st limb (or at DES) 2 years= Endo patency 2 Atherectomy nd limb at 2 years = /- adjunct Likelihood Endoluminal of Clinical stent Success graft at 2 years: Probability Fem-Pop of anatomic Bypass Grafting success in two legs= Vein (AK or BK) Prosthetic (AK) Prosthetic (BK) mm FP lesions 50% SES failure at 1 yr J Vasc Surg 2012;55:

4 In-Stent Restenosis: The Ongoing Challenge for Vascular Intervention Growing impact of restenosis on the surgical treatment of peripheral arterial disease. Jones D et al; JAHA % Proportion of all LEB (N=3,504) performed as secondary procedures, By indication and year 43% Armstrong Ej et al Cath Cardiovasc Interv 2013; 82: % 30% 20% 0% 72% increase, p< % 38% 30% 31% 29% 29% 27% RESTENOSIS IS THE NEW 26% 22% 28% VASCULAR EPIDEMIC 21% 21% 23% 19% 23% Critical Limb Ischemia 18% 17% 8% 12% 9% 6% 4% Claudication Impact of Treatment Failure on Surgical Options in PAD Many advocate endovascular first treatment strategies o o Presumed harmless as long as bypass targets remain intact Stakes may increase with each PVI However, prior work has suggested that bypass following a failed prior peripheral endovascular intervention (PVI) is associated with poorer outcomes o BASIL trial, Bradbury AW, et al, J Vasc Surg, 2010 o Nolan BW, et al, J Vasc Surg, 2011 o Simons JP, et al, J Vasc Surg, 2012 Growing impact of restenosis on the surgical treatment of peripheral arterial disease. Jones D et al; JAHA 2013 Propensity score adjustment included approximately 20 patient-level, anatomic and surgical variables The difference in outcomes is increasing with observation time 4

5 What are the potential explanations for inferior bypass outcomes after PVI failure? Systemic Factors (i.e. Bad Patient) Being a poor surgical candidate associates with pushing the envelope in PVI Change in DANA to more distal target Embolization of runoff vessels in calf and foot Target artery inflammation/injury from catheter and wire manipulations Delay in effective revascularization for CLI further tissue loss, infection worsens limb stage End of nitinol stent Fem-tib for limb salvage after failed full metal jacket for claudication (fortunately, did OK) Was a bridge burned? Would 100 of these bypass grafts do as well as 100 fem-pop BPGs? Is treatment failure worse than the natural progression of disease? Everything we do has the potential for negative, unintended consequences Those who don t manage those consequences may lack full perspective 5

6 In treating lifestyle limiting claudication, shared decision-making should include honest discussions about the durability of the intervention and the likelihood of sustained functional improvement, as well as the possible negative sequelae of treatment failure Evidence-Based Practice in PAD? We are going to have to become MORE SELECTIVE about who we treat, and how we treat them, to demonstrate EFFECTIVENESS and VALUE [Fewer Procedures, Better Outcomes] Industry Vascular Specialists Professional Societies 6