Cryoplasty versus conventional angioplasty in peripheral arterial disease: 3 year analysis of reintervention free survival by treatment received. Poster No.: C-0343 Congress: ECR 2011 Type: Scientific Exhibit Authors: A. García - Lallana Valbuena 1, M. L. Diaz 1, F. Urtasun 2, R. Saiz- Mendiguren 1, J. I. Bilbao 1 ; 1 Pamplona/ES, 2 Pamplona, Na/ES Keywords: Interventional vascular, Fluoroscopy, Angioplasty DOI: 10.1594/ecr2011/C-0343 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. www.myesr.org Page 1 of 14
Purpose Background: Long-term primary patency represents the main hurdle in the treatment of superficial femoral artery (SFA) and popliteal lesions Three-year primary patency rates of 50% have been reported for percutaneous transluminal angioplasty (PTA) and first-generation stents. 2-year primary patency rates of 60% to 84%, respectively, have been reported with newer nitinol stents. Cryoplasty builds on conventional PTA by applying cold thermal energy to the vessel wall. I works by three mechanisms of action: Altered plaque response Reduced elastic recoil Smooth muscle cell apoptosis Early results with Cryoplasty appear promising, with initial treatment success rates of 96% and patency rates of 84,4% at 12 months Purpose: To compare long term efficacy and safety of Cryoplasty versus conventional angioplasty in the treatment of infrainguinal arterial occlusive disease. Images for this section: Page 2 of 14
Fig. 1: Cryoplasty device Page 3 of 14
Methods and Materials Fig.: Distal vessel run off Page 4 of 14
Fig.: TASC II lesion classification Page 5 of 14
Fig.: Patient s risk factors and comorbid conditions Page 6 of 14
Fig.: Inclusion criteria From Jan. 2004 to June 2006, 155 patients with 192 atherosclerotic lesions involving the SFA and popliteal arteries were randomized to receive Cryoplasty therapy or conventional angioplasty. Clinical evaluation of the patients including ABI measurements were performed at 1, 3, 6, 12 and 36 months. Primary endpoint was treatment success without the need for further intervention There were 130 men and 25 women; mean age 72.6; range 43-89 years 86 patients were randomized to receive Cryoplasty and 69 to receive conventional angioplasty Stenting was performed as required Results Page 7 of 14
Fig.: Primary lesion patency. Kaplan Meyer survival curve Page 8 of 14
Fig.: Target lesion patency Page 9 of 14
Fig.: Long term results Page 10 of 14
Fig.: Immediate results and complication rates Page 11 of 14
Fig.: Immediate results of the procedure In the crioplasty group, technical immediate success was achieved in 81% lesions. Rate of significant dissection was 11,3%. Rate of stent placement was 14,5%. Target lesion primary patency, defined as the absence of clinically driven repeat revascularization of the lesion or the need for surgical bypass grafting or amputation owing to occlusion of the treated lesion, at 6 months was 78%, with rates of 68%, 51% and 44% at 1, 2 and 3 years respectively. In the conventional angioplasty group, rate of stent placement due to residual stenosis or dissection was 70%. Target lesion primary patency at 6 months was, with rates of 60%, 53%, and 40% at 1,2 and 3 years respectively, however, no significant differences between the two groups were found. Conclusion Page 12 of 14
Cryoplasty therapy of femoro-popliteal lesions is a safe technique that can dilate most lesions with low morbidity. Compared with the conventional angioplasty group, significantly lower stent rates were found in the Cryoplasty group. In the long term, Cryoplasty was associated with slightly better patency rates compared with conventional angioplasty although the differences were not statistically significant. References John R. Laird. Limitations of Percutaneous Transluminal Angioplasty and Stenting for the Treatment of Disease of the Superficial Femoral and Popliteal Arteries. Journal of Endovascular Therapy: February 2006, Vol. 13, No. Supplement II, pp. II-30-II-40. Laird J, Jaff M, Biamino G, McNamara T, Scheinert D, Zetterlund P, et al. Cryoplasty for the treatment of femoropopliteal arterial disease: Results of a prospective, multicenter registry. J Vasc Interv Radiol 2005; 16:1067-73. Samson RH, Showalter DP, Lepore M, et al. Cryoplasty therapy of the superficial femoral and popliteal arteries: a reappraisal after 44 month s experience. J Vasc Surg 2008; 48:634-637 Jahnke T, Mueller-Huelsbeck S, Charalambous N, et al. Prospective, Randomized Single-center Trial to Compare Cryoplasty versus Conventional Angioplasty in the Popliteal Artery: Midterm Results of the COLD Study October 2008 (Vol. 19, Issue 10, Pages 1460-1466) Spiliopoulos S, Katsanos K, Karnabatidis D, et al. Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial. Cardiovasc intervent Radiol. 2010 Jun 24 (ahead of print) Personal Information Page 13 of 14
Fig.: email address Page 14 of 14