Nicolas W Shammas, MD, MS
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1 Rota%onal and Aspira%on Atherectomy in Trea%ng in- Stent Restenosis of Femoropopliteal Arteries: Final Results of the JETSTREAM- ISR Feasibility Study Nicolas W Shammas, MD, MS President and Research Director, Midwest Cardiovascular Research Foundation Interventional Cardiology, Cardiovascular Medicine, PC
2 Disclosure Statement Within the past 12 months, I or my spouse/partner have had a relevant financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Trainer Educational Grants Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Boston Scientific, Bayer Boston Scientific, Covidien, Gilead, Pfizer, BMS, Astra Zenaca Covidien, Boston Scientific To MCRF: full list N/A N/A N/A N/A N/A JetStream is an off label application in treating Femoropopliteal ISR.
3 Scope of the Problem: Femoropopliteal In-Stent Restenosis (FP-ISR): Fempop ISR occurs in 20-30% of stented pa9ents at 1 year and up to 49% at 2 years Treatment of FP ISR with POBA carries a high rate of TLR at one year (31% to 47%) and reduced patency rates (28% to 37%) New therapies including atherectomy, grao sten9ng, DCB and DCS are being tested or now available to treat FP ISR It is es9mated that the incidence of FP ISR is over 120,000 cases per year
4 JetStream ISR Feasibility Study DESIGN: Prospective, feasibility registry at 2 centers, evaluating JetStream XC atherectomy (JS) in treating Femoropopliteal in-stent restenosis (FP ISR) 29 patients (32 limbs) enrolled at 2 clinical sites between October 2012 and August 2014 in the United States 32 limbs crossed intraluminally/js+pta OBJECTIVE: To evaluate efficacy and safety of JS with adjunctive PTA (JS+PTA) and assess stent-device interaction using Angiographic Core Lab adjudication Primary Efficacy/ Safety endpoints at 1 mo (n=32) Stent Integrity evaluation per core lab (n=24) PRINCIPAL INVESTIGATOR Nicolas W Shammas, MD, MS SUBINVESTIGATOR Subhash Banerjee, MD Angiographic Core Laboratory Beth Israel Deaconess Med Ctr Jeffrey Popma, MD Primary Safety endpoint and TLR (n=27 pts; n=29 limbs) 1 patient died (2 limbs) 1 patient withdrew (1 limb)
5 JetStream XC Cutter size: JETSTREAM XC - 2.1mm/3.0mm 120 cm Vessel size mm BD mm BD/BU mm - 2.4mm/3.4mm 135 cm Vessel size > 5.0 mm
6 Porcine overstretched injury model of Femoral Artery ISR Partial overlapping stents, fully overlapping stents, Stent across branches Stents fully expanded Shammas NW et al. In Print (JEVT 2015)
7 Primary Endpoints Primary Efficacy Endpoint Acute Procedural Success Less or equal 30% residual narrowing With no serious adverse events Acute Device Success (secondary endpoint) (Less or equal 50% residual narrowing after JS alone) Primary Safety Endpoint Major Adverse Events : In-hospital: Treated DE, Perforation, Major Bleeding, death, amputation, acute closure, access complication, Acute renal failure, adverse stentdevice interaction (fracture/deformity) 30 days and 6 months: Death, unplanned amputation, freedom from clinically driven TLR (recurrence of symptoms with abnormal ABI or confirmed loss of patency angiographically >50% lesion ), Stent deformity and fracture (6 months)
8 Inclusion and Exclusion Criteria Inclusion Criteria Femoropopliteal lesions with in-stent restenosis of > 50% Rutherford-Becker category of 1-5 One patent infrapopliteal distal runoff Vessel Diameter of > 5 mm No lesion length limit Exclusion Criteria Not able to give informed consent Unable to take antiplatelet drugs post procedure Cr > 2.5 mg per dl Planned surgical or endovascular procedure within 15 days of the index procedure Displaced stent fractures
9 Clinical and Angiographic Variables Demographic and Clinical Angiographic Age (mean) yrs 69.9 Treated length mm 19.5 ± 12.9 Male 37.9 % Lesion Diam. mm 5.3 ± 0.8 Hyperlipidemia 82.8 % Run-off vessels 1.8 ± 0.9 Diabetes 41.4 % Stenosis Severity % 79.6 ± 16.3 Hypertension 89.7 % Stenosis post JS % 45 ± 15.5 Current smoking 41.4 % Stenosis post PTA % 20 ± 10.7 Prior index lesion ISR 66.0 % TASC C/D 62.5 % Prior PCI 48.3 % Blades Up run time min 2.5 ± 1.6 Rutherford Category Blades Down run time min 2.9 ± % Treatment Interval min 5.1 ± % JS XC % % JS XC % % Mean Volume Aspirate ml 230 On Aspirin 90.6 % Lesions > 30 cm/cto 25 %/25% On ADP-receptor antagonist 75 % Stent Fracture 1&2 3/24 (12.5%)
10 Intraprocedural Outcomes/Complications Device Success 75.9 % Residual Stenosis <30%(post adjunctive balloon) 100% Procedural Success (no SAE) 90.6 % Stenting post JS/PTA 9.4% Bail out stenting (2/32) 6.3% Treated Distal Embolization 9.4% New Stent Fracture or No Filter 6.3 % Spider Filter 3.1% Nav-6 Filter 0% 0% Deformities (Core Lab)(n=24) No Abrupt Closure, acute thrombosis, perforation, major bleeding
11 JetStream ISR patient: Baseline, postjs and post adjunctive balloon angioplasty Baseline Post Jetstream Post Angioplasty
12 Primary Safety endpoint: 30 d and 6 months TLR/TVR 30 days 0 % Death 30 days 0 % Amputation 30 days 0 % Death 6 months (non vascular) 3.4 % Freedom from TLR 6 mo (not including intraprocedural bail out stenting as TLR) Freedom from TLR 6 mo (including intraprocedural bail out stenting as TLR) 86.2 % 79.3 % Patency 6 mo 72 % New Stent Fracture or Deformities (Core Lab) at 6 mo (n=24) 0 % Amputation 6 mo 0 %
13 Freedom from TLR (censored)
14 ABI and Rutherford Becker Category Baseline 6 months Baseline ABI 0.7 ± month ABI 0.8 ± 0.2 (p=0.039) Rutherford Category Rutherford Category (p=0.035) % % 1 & 2 0% 1 & % % % % % % %
15 Atherectomy for FP ISR: TLR* at 6 mo and 1 yr Atherectomy in FP ISR DCB/DCS in FP ISR *TLR does not include bail out stenting Liistro F. DEBATE- ISR. J Endovasc Ther. 2014;21:1-8; Krankenberg. FAIR Trial. LINC 2014; Dippel EJ. EXCITE ISR JACC Cardiovasc Interv. 2015;8 (1 Pt A): ; Shammas NW. SilverHawk in in- stent restenosis Cardiovasc Revasc Med. 2012;13:341-4 ; Shammas NW Excimer laser in in- stent restenosis Cardiovasc Revasc Med. 2012;13:341-4 ; Schmidt A. PATENT. J Endovasc Ther. 2014;21:52-60; Dake MD. Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4: ; Stabile E. J Am Coll Cardiol. 2012;60: ; Zeller T. JACC Cardiovasc Interv. 2013;6:
16 Conclusions JS atherectomy is effective and safe in this feasibility prospective registry in treating FP ISR: In long lesions averaging 19.5 cm in length, CTO 25% With high procedural (100% < 30% residual) and device success (75.9% < 50% residual) No stent-device interaction by adjudicated Angiographic Core Lab (even in Class 1 and 2 fractures and stent overlap) TLR rates in the same range as published literature for laser JS atherectomy for FP ISR is off label and this data needs to be validated in a larger prospective trial Combining atherectomy with DCB in treating FP ISR may be promising and is currently being investigated
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18 Rota%onal and Aspira%on Atherectomy in Trea%ng in- Stent Restenosis of Femoropopliteal Arteries: Final Results of the JETSTREAM- ISR Feasibility Study Nicolas W Shammas, MD, MS President and Research Director, Midwest Cardiovascular Research Foundation Interventional Cardiology, Cardiovascular Medicine, PC
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