Novel hybrid nitinol ring stent (TIGRIS Gore)placement for atherosclerotic disease in the popliteal artery in 50 limbs

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1 Novel hybrid nitinol ring stent (TIGRIS Gore)placement for atherosclerotic disease in the popliteal artery in 50 limbs Poster No.: C-2437 Congress: ECR 2015 Type: Scientific Exhibit Authors: A. Parthipun, A. Diamantopoulos, P. Kitrou, N. Karunantihy, I. Ahmed, P. Gkoutzios, S. Padayachee, K. Katsanos; London/UK Keywords: DOI: Interventional vascular, Cardiovascular system, Vascular, Catheter arteriography, Stents, Angioplasty /ecr2015/C-2437 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 7

2 Aims and objectives The TIGRIS (Gore Medical) stent is a novel hybrid vascular stent that consists of independent nitinol rings encapsulated and interconnected by an expanded heparinbonded PTFE structure. The authors report the immediate and mid interim results of a single centre prospective study investigating the TIGRIS stent in the popliteal artery. To report the immediate and midterm outcomes of this novel hybrid heparin bonded stent for the treatment of artherosclerotic lesions located in the popliteal artery. Methods and materials This was a single centre prospective single arm registry. Patients eligible for inclusion were individuals suffering from peripheral arterial disease due to either de-novo or restenotic infrainguinal arterial obstructive disease (Rutherford-Becker stage 3-5) located in the popliteal artery treated with primary placement of TIGRIS stent following balloon pre-dilatation as necessary. Patients were prospectively scheduled for both clinical and imaging follow-up (assessed with duplex ultrasound) at 6 and 12 months' time periods. Primary outcome measures included immediate technical and procedural success. While secondary outcomes included lesion restenosis (evaluable by Duplex; PSVR<2), target lesion revascularization (TLR), limb salvage and stent patency at 12 months as calculated by Kaplan-Meier survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for various covariates and search for independent adverse predictors of outcomes. Images for this section: Page 2 of 7

3 Fig. 1: Fig.1. Angiographic images of the TIGRIS stent in situ in the popliteal artery both in extension and in flexion. On these views, it is possible to demonstrated that this stent adheres closely to the anatomy of the popliteal artery Page 3 of 7

4 Results From August 2012 to March 2014, a total of 54 TIGRIS stents were inserted in 50 limbs of 48 patients (27 men; 21 women; mean age ± 1.65 years) (74.00% were occlusions)procedural success was achieved in all cases. Treated lesion length ± 69.7mm (range, 8-20cm). The mean stent length was ± 36.9mm (range mm). Median follow-up period was ± 0.82 months. The primary patency rate was 69.5 at twelve months with binary restenosis being evident in half of the toatla treated cases (51,4%) and 13.9% of them requiring a clinical driven re-intervention as estimated by Kaplan-Meier survival analysis. Payient survival, limb salvage and amputation free survival were high at one year (90.9%, 95,8% and 87% respectively). Cox analysis identified the presence of severe calcifications, diabetes, real impairment and smoking as independent variables resulting in significant poor outcomes in terms of higher binary restenosis rates during follow-up. Images for this section: Fig. 2: Table demonstrating demographic results Page 4 of 7

5 Fig. 3: Secondary outcomes at 6 and 12 months Fig. 4: Table demonstrating comparison of our study against other published data Page 5 of 7

6 Conclusion All popliteal lesions were successfully treated with a TIGRIS stent. Primary patency at 6 months was 95% and at 12 months was 69.5%. The new hybrid heparin-bonded TIGRIS stent may represent a potentially safe and effective endovascular option for the popliteal artery. Personal information ¹Aneeta Parthipun, BSc (Hons), MBBS, FRCR, ¹Athanasios Diamantopoulos, MD, PhD, ¹Panagiotis Kitrou, MD, PhD, ²Soundrie Padayachee, PhD CSci MIPEM, ¹Narayan Karunanithy, MBBS, FRCR, EBIR, ¹Irfan Ahmed, MBBS, FRCR, #Hany Zayed, MBBS, FRCS, ¹Konstantinos Katsanos, MD, MSc, PhD, EBIR ¹Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, SE1 7EH, King's Health Partners, London, United Kingdom ²Department of Angiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, SE1 7EH, King's Health Partners, London, United Kingdom #Department of Vascular Surgery, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, SE1 7EH, London, United Kingdom References References: Page 6 of 7

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