Paclitaxel-coated versus Plain Balloon Angioplasty in the Treatment of Infrainguinal Vein Bypass Stenosis
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1 Paclitaxel-coated versus Plain Balloon Angioplasty in the Treatment of Infrainguinal Vein Bypass Stenosis T. Hölzenbein, A. Ugurluoglu, M. Aspalter, W. Hitzl, K. Linni Dep Vascular & Endovascular Surgery PMU Salzburg, Austria
2 Disclosure Speaker name: Hölzenbein, T... I have the following potential conflicts of interest to report: Consulting Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Background Treatment of bypass stenoses Vascular injury after PTA Neointimal hyperplasia Antiproliferative substances 1 New techniques to achieve greater efficacy 2 PACIFIER trial and LEVANT I study 3,4 1.Camenzind E, Bakker WH, Reijs A, van Geijlswijk IM, Boersma E, Kutryk MJ, Krenning EP, Roelandt JR, Serruys PW. Site-specific intracoronary heparin delivery in humans after balloon angioplasty: a radioisotopic assessment of regional pharmacokinetics. Circulation 1997;96: Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 2004;110: Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, et al. Paclitaxel-coated balloons reduce restenosis after femoropoliteal angioplasty. Evidence from the randomized PACIFIER trial. Circ Cardiovasc Intervent 2012;5: Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femorpopliteal restenosis) trial for femoropopliteal revascularization. JACC Cardiovasc Intervent 2014;7(1):10-19
4 Aim of the Study Patency Hemodynamic improvement Clinical improvement Limb salvage Survival
5 Study Endpoints PRIMARY Primary patency Secondary patency SECONDARY Clinical improvement Hemodynamic improvement Limb salvage Survival
6 Graft at-risk Significant (>70%) bypass stenosis verified by duplex (peak systolic velocity < 45 cm/s or >300cm/s or peak systolic velocity ratio > 4) 5,6 5. Mills JL Sr, Wixon Cl, James DC, Devine J, Westerband A, Hughes JD. The natural history of intermediate and critical vein graft stenosis: recommendations for continued surveillance or repair. J Vasc Surg 2001;42: Davies AH, Magee TR, Tennant SG, Lamont PM, Baird RN, Horrocks M. Criteria for the identification of the at-risk infrainguinal bypass graft. Eur J Vasc Surg 1994;8:
7 Technique Plain balloon angioplasty (Group A) vs Paclitaxel-coated balloon angioplasty (Group B) Retrospective Design Follow up: Mean: 2.93 vs 2.18 (P =.08) for Group A and B No patient was lost to follow-up
8 Consort Diagram Assessed for Eligibility (n=105) 4/ /2014 Excluded (n=22) - Bypass occlusion (n=6) - Surgical and endovascular treatment (n=6) - Both types of balloons used ( n=4) - Additional stent deployment (n=3) - Prosthetic bypass (n=3) Included (n=83) Group A Plain balloon angioplasty (n=41) Group B Paclitaxel-coated balloon angioplasty (n=42)
9 Demographic Data and Cardiovascular Risk Factors Plain PTA (n = 41) Paclitaxel-coated PTA (n = 42) P Value Mean age in years (± SD) 71 (± 10.6) 70 (± 7.38) 0.8 Female (n/%) 16/39 9/ BMI (± SD) (± 4.8) (± 3.5) 0.9 Hypertension (n/%) 39/95 40/ Hyperlipidemia (n/%) 26/63 23/ Diabetes (n/%) 19/46 17/ Coronary disease (n/%) 23/56 23/ Smoking (n/%) 14/34 15/36 1.0
10 Indication for Bypass PTA and Bypass Characteristics Plain PTA (n=41) Paclitaxel-coated PTA (n=42) P Value Rutherford category 2 (n/%) 2/5 10/ Rutherford category 3 (n/%) 22/54 21/ Rutherford category 4 (n/%) 2/5 3/7 1.0 Rutherford category 5 (n/%) 13/32 7/ Rutherford category 6 (n/%) 2/5 1/2 0.6 GSV bypass (n/%) 29/71 28/ Arm vein bypass (n/%) 11/27 12/ LSV bypass (n/%) 1/2 2/5 1.0 Redo bypasses (n/%) 15/37 12/ Below-knee bypass (n/%) 26/63 28/67 0.8
11 Procedural Findings Plain PTA (n=41) Paclitaxel-coated PTA (n=42) Proximal anastomosis stenosis (n/%) 8/20 7/ Distal anastomosis stenosis (n/%) 17/41 19/ Proximal in-graft stenosis (n/%) 3/7 13/ Middle in-graft stenosis (n/%) 11/27 11/ Distal in-graft stenosis (n/%) 10/24 4/ P Value Mean balloon length in mm (± SD) 30 (± 14.9) 51 (± 17.2) < Mean balloon diameter in mm (± SD) 3.7 (± 0.8) 3.8 (± 1.1) 0.8 Mean operative time in min (± SD) 45.2 (± 15.6) 47.0 (± 19.5) 0.6 Mean radiation time in min (± SD) 7.1 (± 4.7) 9.5 (± 6.9) 0.08 Mean contrast medium in ml (± SD) 109 (± 51.0) (± 38.3) 0.9
12 Primary Study Endpoints Proximal in-graft stenosis (Cox F, p =.041) Redo bypass procedure (Cox F, p =.0001) Repeat TLR rates were 22% vs 14% (p =.17) 7 successful re-angioplasties for stenosis in Group A 3 successful re-interventions for stenosis in Group B 8 vs 7 bypass occlusions (p =.74) All re-pta s (n = 5) for bypass occlusion failed In 10 cases of bypass occlusion no salvage procedure was performed
13 Primary Patency
14 Secondary Patency
15 Secondary Endpoints Hemodynamic improvement rates: 88% vs 86% (p = 1.0) for Group A and B Clinical improvement rates were 70% vs 73% (p = 0.8) for Group A and B 3 vs 1 major amputations (p = 0.36) for Group A and B Survival rates: 81% vs 84% (p = 0.78) for Group A and B
16 Conclusion Technical success Hemodynamic and clinical outcome Study limitations Retrospective, not randomized Single center Randomized studies probably useful
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