Jetstream Atherectomy in Treating De Novo or Non-Stent Restenotic Femoropopliteal Disease: One-Year Results from the JET Registry

Transcription

1 Jetstream Atherectomy in Treating De Novo or Non-Stent Restenotic Femoropopliteal Disease: One-Year Results from the Lawrence A. Garcia, MD St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA, USA for the Investigators

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting (non-compensated) Abbott, Medtronic Medtronic, Boston Scientific, Abbott Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Arsenal, Primacea, TissueGen, CV Ingenuity, Spirox, Scion Cardiovascular, Syntervention, Essential Medical None Innovation Vascular Partners, Consulting None None

3 : Study Overview Principal Investigator Objective Study Design Subjects Investigational Centers Endpoints William Gray, MD Department of Cardiology, Columbia University Medical Center, New York, NY Observe the treatment effects of the Jetstream TM Atherectomy System in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries Multicenter, open label, non-randomized registry 241 patients with femoropopliteal lesions Key inclusion criteria: Rutherford category of 1-3 de novo or restenotic (non-stent), 70% stenosis or occlusion, lesion length 4.0 cm 1 patent runoff vessel 37 sites (USA) Primary: Binary restenosis at 12 months (core lab-assessed DUS-derived peak systolic velocity ratio >2.5) Secondary: 30-day freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization) Procedural success ( 30% residual diameter stenosis post-procedure) Rutherford category improvement (reduction 1 category) ABI improvement (increase 0.10 from baseline) ABI, ankle-brachial index; DUS, duplex ultrasound, MAE, major adverse event; MI, myocardial infarction; TLR/TVR, target lesion/vessel revascularization

4 Investigators Principal Investigator Institution Principal Investigator Institution Nicolas Shammas Manish Mehta Rajesh Dave Kane Chang Nelson Bernardo Thomas Davis Russell Wood Midwest Cardiovascular Research Foundation, Davenport, IA Albany Medical Center, Queensbury, NY Holy Spirit Hospital, Camp Hill, PA Deborah Heart and Lung, Brown Mills, NJ Washington Hospital Center, Washington DC St. John Hospital, Detroit, MI Washington Regional, Fayetteville, AR Lawrence Garcia Prakash Makam Zvonimir Krajcer Paul Amoroso George Zaleski Neerav Shah Mark Koenig St. Elizabeth's Medical Center, Boston, MA Cardiovascular Association of Northwest Indiana, Munster, IN St. Luke's Episcopal Hospital, Houston, TX Multicare Health System, Tacoma, WA Wheaton Franciscan Health System, Racine, WI Cardiology Partners Clinical Research Institute, Wellington, FL St. Thomas Medical Center, Nashville, TN Britton Eaves Christopher D. Metzger Willis Knighton Health System, Shreveport, LA Wellmont CVA Heart Institute, Kingsport, TN Andrey Espinoza Richard Heuser Bashir Lone Hunterdon Medical Center, Flemington, NJ St. Luke's Research, Phoenix Heart Center, Phoenix, AZ South Carolina Heart Center, Columbia, SC Yazan Khatib First Coast Cardiovascular Institute, Jacksonville, FL Shawn Sarin George Washington University Medical Center, Washington DC Henry Meltser Wei Zhou Atul Kukar Jean Starr Rajul Patel Robert Beasley Cardiology Group of Western NY, Williamsville, NY VA Palo Alto Health Care System, Palo Alto, CA Lenox Hill Hospital, Lenox Hill, NY Ohio State University, Columbus, OH Phoenix Heart, Glendale, AZ Mount Sinai Medical Center, Miami, FL Charles Botti Anvar Babaev Christopher LeSar Chris Lecroy Jeffrey J. Marshall Ohio Health Research Institute, Columbus, OH NYU Medical Center, New York, NY University Surgical Associates, Chattanooga, TN Coastal Vascular & Interventional, Pensacola, FL North Georgia Heart Foundation,, Gainesville, GA Greg Kasper David Mego St. Vincent's Hospital, Toledo, OH Arkansas Heart Hospital, Little Rock, AR Ramzan Zakir St. Peter s University Hospital, New Brunswick, NJ

5 Jetstream System Overview JETSTREAM XC Catheters JETSTREAM SC Catheters XC 2.1/3.0mm SC 1.6mm XC 2.4/3.4 mm SC 1.85mm (SFA & Popliteal Sizes) (Tibial Sizes) Control POD Console Over-the-Wire Approved for use with BSC cm Thruway Guidewire Approved for use with Atherectomy Lubricants, such as Rotaglide

6 Patient Characteristics 241 patients (258 lesions) Overall (N=241) Age (years), mean ± SD 67.1 ± 9.8 Male 66.0% Medical History Hypertension 82.6% Hypercholesterolemia 66.8% Smoking 50.6% Heart Disease 47.7% Diabetes 41.1% Race Caucasian 80.1% African American 16.6% Native American 2.1% Other 1.2%

7 Lesion Characteristics Overall (N=258 lesions) Non-Stent a (N=165 lesions) Stent a (N=93 lesions) Lesion location Superficial Femoral 75.6% 72.1% 81.7% Common Femoral 10.9% 15.2% 3.2% Popliteal 13.6% 12.7% 15.1% Lesion length, mean ± SD 16.4 ± 13.6 cm 14.1 ± 12.6 cm 20.5 ± 14.4 cm Calcium Grade b % 10.2% 9.5% % 14.6% 19.0% % 17.8% 35.7% % 31.8% 21.4% % 21.0% 16.7% Lesion RVD, mean ± SD 5.7 ± 0.9 mm 5.5 ± 0.9 mm 5.9 ± 0.9 mm Occlusion (100% stenosis) 36.1% 28.7% 50.0% Pre-treatment stenosis estimate, mean ± SD 91.1% ± 9.8% 90.2% ± 10.0% 92.7% ± 9.4% a Post hoc analysis of patients who received and did not receive adjunctive stents. b Calcium grading: 0= no visible calcification; 1= one individual segment of vessel calcification representing <25% of the length of the entire segment; 2= aggregate calcification representing <50% of the segment length; 3= aggregate calcification representing >50% of the segment length; 4= dense circumferential calcification along the segment length.

8 Procedures Procedure time: 73.4 ± 37.5 min Total Jetstream run time: 4.7 ± 3.5 min Number of Passes Blades Down: 2.0 ± 1.5 Blades Up: 1.8 ± % procedural success ( 30% residual diameter stenosis postprocedure) 84 patients (35%) received adjunctive stents Stent placement performed at operator s discretion Embolic protection used in 22.4% of cases Overall (N=258 lesions) Non-Stent (N=165 lesions) Stent (N=93 lesions) Post-treatment stenosis estimate, mean ± SD Post-Jetstream 44.4% ± 20.0% 38.5% ± 16.2% 54.8% ± 22.0% Post Adjunctive Treatment 9.8% ± 11.4% 11.6% ± 11.7% 6.6% ± 10.2%

9 Efficacy & Safety 22.8% overall restenosis rate at 12 months Overall Population (N=241) Non-Stent (N=157) Freedom from TVR/TLR through 12 Months Stent (N=84) Binary Stenosis a, % (n/n) 30 Days 2.6% (3/116) 3.8% (3/80) 0.0% (0/36) 12 Months 22.8% (13/57) 20.5% (8/39) 27.8% (5/18) a Core lab-assessed DUS-derived PSVR >2.5 Stent 85.2% Overall 81.7% Non-stent 79.9% Time from Index Procedure (Months) At risk Overall Stent Non-Stent DUS, duplex ultrasound; PSVR, peak systolic velocity ratio

10 Safety Summary 2.3% overall MAE rate at 30 days 38 TVR/TLR by 12 months 3 distal embolization events 30 Days (N=219) 12 Months (cumulative; N=219) MAE 2.3% 19.2% Death 0% 2.3% Amputation 0% 0.5% Myocardial infarction 0% 0% TVR or TLR 0.9% 17.4% (Non-stent 19.4%, Stent 13.8%) Distal embolization 1.4% 1.4% MAE, major adverse event; TLR, target lesion revascularization; TVR, vessel revascularization

11 Patient Outcomes Overall (N=241) Non-Stent (N=157) Stent (N=84) Rutherford Category Improvement a 30 Days 81.3% 79.1% 85.0% 12 Months 73.4% 75.7% 69.4% ABI Improvement b 30 Days 73.5% 71.9% 76.3% 12 Months 58.2% 60.0% 54.8% a Reduction 1 category from baseline b Increase 0.10 from baseline 70% with no or minimal symptoms at 12 months (category 0-1) 100% 80% 60% 40% 20% 0% Rutherford Category Distribution- Overall Baseline (N=241) 6 Months (N=184) 12 Months (N=170) ABI, ankle-brachial index

12 Conclusions results show: Long femoropopliteal lesions in the real-world study population (mean 16 cm) with excellent safety profile and high procedural success rate (98.3%) 12-month primary patency (77.2%) consistent with previous studies of femoropopliteal atherectomy Low TLR/TVR rate (18.3%) Study limitations High proportion of patients received stents Limited DUS follow-up at 12 months

13 Jetstream Atherectomy in Treating De Novo or Non-Stent Restenotic Femoropopliteal Disease: One-Year Results from the Lawrence A. Garcia, MD St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA, USA for the Investigators