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A PROSPECTIVE MULTICENTRE REGISTRY FOR THE ASSESSMENT OF SAFETY AND EFFICACY OF BIODEGRADABLE POLYMER TM* COATED, PACLITAXEL ELUTING STENT LUC 9 th month study *(BALTON, POLAND) P. Buszman1,2, R. Gil3, J. Rzezniczak4, T. Przewlocki5, M. Kosmider6, J. Wojcik7, J. Janczak8, S. Trznadel2, L. Kinasz2, M. Kondys2, M. Krol2, K. Milewski1,2 1. Silesian Medical School, Katowice 2. American Heart of Poland, Ustron 3. Central Hospital of the Ministry of Internal Affairs, Warsaw 4. Department of Cardiology, District Hospital, Poznan 5. Institute of Cardiology, CM, JU, Kraków 6. Department of Cardiology and Cardiac Surgery, Medical School, Lodz 7. Division of Cardiology, Lublin 8. Department of Cardiology, Central Military Hospital, Warsaw LIMITATIONS OF POLYMER COATED DES’s Although polymers can ensure predictable release of different drugs, in some cases they cause exaggerated inflammatory response, neointimal hyperplasia and thrombosis. Biodegradable polymer – drug eluting stents (BPDES) are to resolve the problem of chronic vascular inflammation and late thrombosis. A new concept: after the drug and polymer are eluted, only neutral stainless steel is left in the vessel wall. CHARACTERISTIC OF LUC STENT The tested stents were made of the highest quality biocompatible 316 stainless steel alloy with 0,13mm strut thickness. The coating was performed utilizing biocompatible and biodegradable polymers, whose exact composition is proprietary to Balton Company. A total amount of polymer mounted on 3,5x15mm stent does not exceed 365 µg. Paclitaxel in dose 1 μg / mm2 was chosen as a drug which inhibits cell proliferatin and thus can inhibit restenosis Molybdenu m 3% Nickel 15% Manganese 2% Chromium 17% Others 0,4 Iron ~63% The composition of BMS Others: carbon, copper, phosphorus, sulphur, silicon. BIODEGRADATION OF TESTED POLYMER The samples of stents covered with tested polymer and removed from isotonic salt solution at different time points The surface of the stent after 1 week The surface after 8 weeks Residual polymer left on the stent surface after 8 weeks ANIMAL STUDY QCA: Late Loss THE AIM: To evaluate safety and intimal hyperplasia after coronary implantation of LUC stent To assess the influence of biodegradable polymer on tested arteries 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 0,48 BMS RESULTS: Neointimal hyperplasia was succesfully inhibited by LUC stents at 30 days f-up. However, after 90 days the parameters of neoitnimal hyperplasia and stenosis severity were similar to BMS. Qualitative histopathological examination did not show excessively negative influence of polymer on tested artery. 0,87 Polymer 0,15 0,52 LUC 1 month LUC 3 months FIRST IN MAN STUDY Prospective, multi-center registry •Poznan •Warszawa •Lodz •Lublin •Katowice •Ustron Bielsko Biała •Krakow FIRST IN MAN STUDY Silesian Medical School, Katowice P. Buszman Katowice American Heart of Poland M. Kondys Ustron Central Hospital of the Ministry of Internal Affairs R. Gil Warszawa Department of Cardiology, District Hospital J. Rzezniczak Poznan American Heart of Poland L. Kinasz Bielsko Institute of Cardiology, CM, JU, Kraków T. Przewlocki Krakow Department of Cardiology and Cardiac Surgery M. Kosmider Lodz Division of Cardiology J. Wojcik Lublin Department of Cardiology, Central Military Hospital J. Janczak Warszawa FIRST IN MAN STUDY Principle Investigator: Pawel Buszman, MD, FESC, FSCAI Clinical Events Committee: Mariusz Gasior Ciecwierz Leszek Angiographic Core Lab: Core Imaging Analysis Laboratory Krakow Cardiovascular Research Institute FIRST IN MAN STUDY Material and method: Enrollment of 113 patients with: de-novo lesion in native coronary artery vessel diameter 2.8 – 4.0 mm lesion length 18 mm stenosis ≥ 50% and ≤100% Dual antiplatelet therapy required for 9months Period of implantation: 07/2005 – 11/2005 FIRST IN MAN STUDY Clinical endpoints: MACE after 30 days, 6 and 9 months Angiographic endpoints: Late loss Restenosis rate F-up visits after 30 days, then subsequently after 3 and 6 months to define MACE rate. 9-months control coronarography PATIENT CHARACTERISTICS Male 83 [73,4 %] Hypercholesterolaemia 68 [60,2 %] Family history 27 [23,8 %] Smoking 64 [56,6%] Diabetes 24 [21,2 %] Hypertension 80 [70,8 %] Pior MI 43 [38,1 %] Stable angina 98 [86,7 %] Unstable angina 10 [8,8 %] STEMI, NSTEMI 2 [1,8 %] Vessel disease Triple 7,1% Double 47,8% Single 45,1% ANGIOGRAPHIC DATA Lesion type Lesion location LAD 41% B1 42% 37% RCA B2 39% A 10% others 5% LCx 17% Direct stenting: n = 74 Predilatation: n = 31 Success rate: 100% C 9% Calcification (moderate to severe) 10% Thrombus 1% Eccentric 70% Angulation <450 93% 45-900 7% CLINICAL OUTCOME 0-1 month 1-6 month 6-9 month Total 0-9 month Any MACE 1 1 1 3 (2.7%) Death 0 0 0 0 MI 0 1 0 1 (0,9%) Acute stent thrombosis 1 0 0 1 (0,9%) Clinically driven TLR 1 1 1 3 (2,7%) 3,0 2,7 2,7 2,0 1,0 0,9 0,9 MI Stent thrombosis 0 0,0 Any MACE death TLR ANGIOGRAPHIC DATA Before procedure After procedure Follow up 9months (n=90) Reference diameter (mm) 2.90 ± 0.44 3.07 ± 0.41 2.98 ± 0.4 MLD (mm) 1.09 ± 0.45 2.65 ± 0.36 2.21 ± 0.6 Lesion length (mm) 13.94 ± 4.7 15.9 ± 4.2 16.0± 4.2 % DS. 62.8 ± 14 13.8 ± 10 27.1±18.4 Acute Gain (mm) - 1.55 ± 0.55 - Late loss (mm) - - 0.45 ±0.5 DISTRIBUTION OF STENOSIS SEVERITY 26 24 22 20 18 16 n 14 12 10 8 6 4 2 0 -20 -10 0 10 20 30 40 50 60 70 80 90 100 %DS Percent diameter stenosis after 9 months 110 BINARY RESTENOSIS RATE AT 9 MONTHS Patterns of in-stent restenosis (Mehran classification) 15 10 10% 10% 5 Focal 4 In-stent 4 Diffuse 1 Occlusive 0 16 14 12 10 8 0 15,8% 6 in-stent in-segment Restenosis rate 4 11,1% 2 5,7% 0% B2 C 0 A B1 Risk of restenosis in relation to type of lesion LUC vs OTHER DES’s 1,0 13,3 14 12 0,62 10 10 8,9 7,9 0,45 8 0,39 6 0,17 4 2 0,0 0 LUC Endeavor-II Taxus-IV Sirius Comparison Among DES Trials Late Loss LUC Endeavor-II Taxus-IV Sirius Comparison Among DES TRIALS Binary Restenosis (In Stent) LUC vs OTHER DES’s 10 8,5 9 7,4 8 7,1 7 6 5 4 3 2,7 2 1 0 LUC Endeavor-II Taxus-IV Sirius Comparison Among DES Trials MACE SUMMARY Excellent procedural outcome with device success 100% Low MACE rate over 9 months after implantation (2.7%) Favorable late (9 months) angiographic results: - Binary restenosis 10,0% - Late loss 0.45 mm