Extreme SFA Lesions: DETOUR I 12- Month Results in Lesions >30cm Sean Lyden, MD Chairman Vascular Surgery Cleveland Clinic Cleveland, Ohio
Extreme SFA Lesions: DETOUR I 12-Month Results in Lesions >30cm Sean Lyden, MD Chairman, Department of Vascular Surgery Cleveland Clinic Cleveland, Ohio
Disclosure Speaker name: Sean Lyden MD... I have the following potential conflicts of interest to report: X Consulting Phillips, Endologix, Shockwave, Abbott, BSC, Spectranetics, Medtronic, PQ Bypass Employment in industry: None Stockholder of a healthcare company: None Owner of a healthcare company: None x Other(s) VIVA Physicians Inc 501c3 Board Member
20 Years into the Endo Revolution, Patients with Long- Segment SFA Disease Have Limited Treatment Options Live with debilitating, lifestyle-limiting pain 50% failure rate by 12M, assuming patient has access to expert care
1-Year Patency 80% Existing Endovascular Devices Designed for Shorter Lesions, Deliver Sub-Optimal Results in Long Lesions Further confounded by complex morphologies: CTO, Ca++, ISR 70% 60% LIMITED TREATMENT OPTIONS 50% 40% Lutonix 5 In.pact 3 Everflex 12 30% 10 15 20 25 30 35 40 Lesion Length (cm) 1 P140002; 2 P140010/S037 3 P070014/S010; 4 P130024; 5 Rocha Singh, Krishna J., et al. Patient level Meta analysis of 999 Claudicants Undergoing Primary Femoropopliteal Nitinol Stent Implantation. Catheterization and Cardiovascular Interventions 89.7 (2017): 1250-1256.; 6 Meta-Analysis of Viabahn Long-Lesion Studies Alimi, Y., Z. Hakam, O. Hartung, M. Bouli, P. Barthelemy, K. Aissi, and M. Dubuc. (2008). Efficacy of Viabahn in the treatment of severe superficial femoral artery lesions:which factors influence long-term patency? Eur J Endovasc Surg. 35: 346-352. Verta, M., J. Schneider, M. Alonzo, and D. Hahn. (2008). Percutaneous Viabahn-assisted subintimal recanalization for severe superficial femoral artery occlusive disease. J Vasc interv Radiol. 19: 493-498.Farraj, N., A. Srivastava, and A. Pershad, (2009). One-year outcomes for recanalization of long superficial femoral artery chronic total occlusions with Viabahn stent graft. J Invasive Cardiol. 21(6): 278-281. Lensvelt, M., W. Fritschy, J. Oostayen, S. Holewijn, C. Zeebregts, and M. Reijnen. (2012). Results of heparin-bonded eptfe-coveredstents for chronic occlusive superficial femoral artery disease. J Vasc Surg. 56:118-125. Garaghty, P., M. Mewissen, M. Jaff, and G. Ansel. (2013). Three-year results of the Vibrant trial of Viabahn endoprosthesis vs bare nitinal stents implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 1-10.Lammer, J., T. Zeller, K. Hausegger, P. Schaefer, M. Gschwendtner, S. Mueller-Huelsbeck, T. Rand, M. Funovics, F. Wolf, A. Rastan, M. Gschwendtner, S. Puchner, R. Ristl, and M. Schroder. (2013). Heparin-bonded covered stents versus bare metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial. Journal of the American College of Cardiology. doi: 10.1016/j.jacc.2013.05.079. Zeller, T., P. Peeters, M. Bosiers, J.Lammer, K. Brechtel, D. Scheinert, A. Rastan, E. Noory, and U. Beschorner. (2014). Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. 21: 765-774. Mohr, P., J. Oyama, J. Luu, and C. Stinis. (2015). Clinical outcomes of endovascular treatment of TASC-II C and D femoropopliteal lesions with Viabahn endoprosthesis. Cardiovascular Revascularization Medicine. 16: 465-468. ; 7 P160025; 8 P120020; 9 P140028; 10 P160004; 11 P110023;
DETOUR I Study Design DESIGN Prospective, single-arm, multi-center clinical evaluation of the DETOUR System and Procedure for Percutaneous Bypass INCLUSION CRITERIA De novo, CTO, or ISR femoropopliteal lesion 10 cm INDEPENDENT REVIEW Core Lab (DUS, CT, Angio) by Cleveland Clinic; Clinical Events Committee by Syntactx 77 Patients/ 81 Limbs Enrolled Follow up at 30D, 3M, 6M, 12M, 18M, 24M, 36M Primary Safety: MAE at 30D (Death, TLR, Amputation) Primary Efficacy: Primary Patency at 6M (PSVR 2.5) with no TLR STATUS: CE Mark granted February 2017
Lesion Length (mm) DETOUR I Lesion Distribution by Length 97.5% 86.4% 71.6% 33.1% >25 cm >30 cm >35 cm >40 cm Lesion Distribution N=81 450 400 350 300 250 200 150 100 50 0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 67 69 71 73 75 77 79 81 DETOUR I Lesions
Baseline Characteristics Extreme ( >30 cm) Lesions Clinical Characteristics N=67 Patients Male Gender 88.1% (59/67) Age, Years 65.1± 7.3 Diabetes Mellitus 26.9% (18/67) Hypertension 86.6% (58/67) Hypercholesterolemia 40.3% (27/67) History of CAD or MI 49.3% (33/67) History of Smoking 77.6% (52/67) Previous Peripheral Intervention 31.3% (21/67) ABI 0.64 ± 0.18 Rutherford 3 94.0% (63/67) Rutherford 4-5 6.0% (4/67) Lesion Characteristics N=71 Lesions / 67 Patients Lesion Length 38.7 cm ± 3.8 cm Range 30.0 cm 47.2 cm % CTO 98.6% (70/71) Calcification Severe 71.8% (51/71) Moderate 12.7% (9/71) Mild 15.5% (11/71) TASC II Lesion Type C 54.9% (39/71) D 45.1% (32/71) Vessel Run-off* 1 7.5% (5/67) 2 31.3% (21/67) 3 61.2% (41/67) *Run-off Not applicable or unavailable for 4 patients
DETOUR I 12-Month Patency Extreme (>30cm) Lesions 76.1% 54/71 81.7% 58/71 94.4% 67/71 Primary Patency Primary Assisted Patency N= 71 Secondary Patency
Safety Outcomes Through 12 Months MAE Extreme (>30cm) Lesions Freedom from MAE through 30 Days Freedom from MAE through 12 Months Freedom from Death 100% (67/67) 98.6% (70/71) Freedom from CD-TLR 93.0% (66/71) 77.5% (55/71) Freedom from Acute Limb Ischemia 100% (71/71) 98.6% (70/71) Freedom from Major Amputation 100% (71/71) 100% (71/71) Venous Health at 12 Months VCSS Scale Baseline 12 Months Change from Baseline P=Value Villalta Scale Baseline 12 Months Change from Baseline P=Value Mean ± SD 0.65 ± 0.97 0.93 ± 1.48 0.25 ± 1.21 0.09 Mean ± SD 0.38 ± 0.80 0.46 ± 0.95 0.07 ± 0.94 0.52
Functional Improvement at 12 Months Extreme (>30cm) Lesions Rutherford Becker Clinical Classification Ankle Brachial Index 100% 80% 60% Significant improvement at 12M (p<0.0001) Baseline 12M 12 Months 0.92 ± 0.14 40% 20% Baseline 0.64 ± 0.18 Significant improvement at 18M (p<0.0001) 0% 0 1 2 3 4 5
1-Year Patency The DETOUR Procedure has the Potential to Fill a Significant Gap in the Endovascular Market An Endovascular Solution that is Complex-Lesion Neutral: CTO, Ca++, ISR 80% 74% 70% 60% 50% Lutonix 4 In.pact 2 40% 30% Everflex 11 10 15 20 25 30 35 40 Lesion Length (cm) 1 P140002; 2 P140010/S037 3 P070014/S010; 4 P130024; 5 Rocha Singh, Krishna J., et al. Patient level Meta analysis of 999 Claudicants Undergoing Primary Femoropopliteal Nitinol Stent Implantation. Catheterization and Cardiovascular Interventions 89.7 (2017): 1250-1256.; 6 Meta-Analysis of Viabahn Long-Lesion Studies Alimi, Y., Z. Hakam, O. Hartung, M. Bouli, P. Barthelemy, K. Aissi, and M. Dubuc. (2008). Efficacy of Viabahn in the treatment of severe superficial femoral artery lesions:which factors influence long-term patency? Eur J Endovasc Surg. 35: 346-352. Verta, M., J. Schneider, M. Alonzo, and D. Hahn. (2008). Percutaneous Viabahn-assisted subintimal recanalization for severe superficial femoral artery occlusive disease. J Vasc interv Radiol. 19: 493-498.Farraj, N., A. Srivastava, and A. Pershad, (2009). One-year outcomes for recanalization of long superficial femoral artery chronic total occlusions with Viabahn stent graft. J Invasive Cardiol. 21(6): 278-281. Lensvelt, M., W. Fritschy, J. Oostayen, S. Holewijn, C. Zeebregts, and M. Reijnen. (2012). Results of heparin-bonded eptfe-coveredstents for chronic occlusive superficial femoral artery disease. J Vasc Surg. 56:118-125. Garaghty, P., M. Mewissen, M. Jaff, and G. Ansel. (2013). Three-year results of the Vibrant trial of Viabahn endoprosthesis vs bare nitinal stents implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 1-10.Lammer, J., T. Zeller, K. Hausegger, P. Schaefer, M. Gschwendtner, S. Mueller-Huelsbeck, T. Rand, M. Funovics, F. Wolf, A. Rastan, M. Gschwendtner, S. Puchner, R. Ristl, and M. Schroder. (2013). Heparin-bonded covered stents versus bare metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial. Journal of the American College of Cardiology. doi: 10.1016/j.jacc.2013.05.079. Zeller, T., P. Peeters, M. Bosiers, J.Lammer, K. Brechtel, D. Scheinert, A. Rastan, E. Noory, and U. Beschorner. (2014). Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. 21: 765-774. Mohr, P., J. Oyama, J. Luu, and C. Stinis. (2015). Clinical outcomes of endovascular treatment of TASC-II C and D femoropopliteal lesions with Viabahn endoprosthesis. Cardiovascular Revascularization Medicine. 16: 465-468. ; 7 P160025; 8 P120020; 9 P140028; 10 P160004; 11 P110023;
DETOUR I 18-Month Patency 67.6% 78.9% 94.4% Primary Patency Primary Assisted Patency N= 68 Secondary Patency
Study (currently enrolling) DESIGN Prospective, single-arm, multi-center clinical evaluation of the DETOUR System and Procedure for Percutaneous Bypass INCLUSION CRITERIA De novo, CTO, or ISR femoropopliteal lesion 15 cm INDEPENDENT REVIEW Core Lab (DUS, CT, Angio) by Cleveland Clinic; Clinical Events Committee by Syntactx 292 Subjects across 40 centers in US and Europe Follow up at 30D, 6M, 12M, 24M, 36M Primary Safety: MAE at 30D (Death, TLR, Amputation, DVT) Primary Efficacy: Primary Patency at 12M (PSVR 2.5) with no TLR STATUS: Enrollment Ongoing
Conclusions DETOUR I trial extreme lesion cohort contains 99% CTO, 72% Severe Ca++, and the largest prospective series evaluating the percutaneous treatment of SFA lesions with an average lesion length of 39 cm Excellent long-term safety in patients with advanced disease and extremely long, complex lesions, with venous health maintained through 12M Promising Durability at 12 months compares favorably with existing therapeutic durability, even in lesions long enough to be excluded from traditional peripheral trials The DETOUR II IDE will build upon the growing body of clinical evidence Enrollment ongoing: Up to 292 subjects Up to 40 centers in US and Europe
Extreme SFA Lesions: DETOUR I 12- Month Results in Lesions >30cm Sean Lyden, MD Chairman Vascular Surgery Cleveland Clinic Cleveland, Ohio