A PROSPECTIVE MULTICENTRE REGISTRY FOR THE ASSESSMENT OF SAFETY AND EFFICACY OF BIODEGRADABLE POLYMER COATED, PACLITAXEL ELUTING STENT LUC TM * *(BALTON,

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Presentation transcript:

A PROSPECTIVE MULTICENTRE REGISTRY FOR THE ASSESSMENT OF SAFETY AND EFFICACY OF BIODEGRADABLE POLYMER COATED, PACLITAXEL ELUTING STENT LUC TM * *(BALTON, POLAND) 9 th month study P. Buszman 1,2, R. Gil 3, J. Rzezniczak 4, T. Przewlocki 5, M. Kosmider 6, J. Wojcik 7, J. Janczak 8, S. Trznadel 2, L. Kinasz 2, M. Kondys 2, M. Krol 2, K. Milewski 1,2 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 (BP- DES) 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 The composition of BMS Others: carbon, copper, phosphorus, sulphur, silicon.

BIODEGRADATION OF TESTED POLYMER The surface of the stent after 1 week The surface after 8 weeks Residual polymer left on the stent surface after 8 weeks The samples of stents covered with tested polymer and removed from isotonic salt solution at different time points

ANIMAL STUDY THE AIM: To evaluate safety and intimal hyperplasia after coronary implantation of LUC stent To assess the influence of biodegradable polymer on tested arteries 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. QCA: Late Loss

FIRST IN MAN STUDY Prospective, multi-center registry Warszawa Lodz Ustron Lublin Poznan Katowice Krakow Bielsko Biała

FIRST IN MAN STUDY Silesian Medical School, KatowiceP. BuszmanKatowice American Heart of PolandM. KondysUstron Central Hospital of the Ministry of Internal AffairsR. GilWarszawa Department of Cardiology, District HospitalJ. RzezniczakPoznan American Heart of PolandL. KinaszBielsko Institute of Cardiology, CM, JU, Kraków T. PrzewlockiKrakow Department of Cardiology and Cardiac SurgeryM. KosmiderLodz Division of CardiologyJ. WojcikLublin Department of Cardiology, Central Military HospitalJ. JanczakWarszawa Silesian Medical School, KatowiceP. BuszmanKatowice American Heart of PolandM. KondysUstron Central Hospital of the Ministry of Internal AffairsR. GilWarszawa Department of Cardiology, District HospitalJ. RzezniczakPoznan American Heart of PolandL. KinaszBielsko Institute of Cardiology, CM, JU, Kraków T. PrzewlockiKrakow Department of Cardiology and Cardiac SurgeryM. KosmiderLodz Division of CardiologyJ. WojcikLublin Department of Cardiology, Central Military HospitalJ. JanczakWarszawa

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 Male83 [73,4 %] Hypercholesterolaemia68 [60,2 %] Family history27 [23,8 %] Smoking64 [56,6%] Diabetes24 [21,2 %] Hypertension80 [70,8 %] Pior MI43 [38,1 %] Stable angina98 [86,7 %] Unstable angina10 [8,8 %] STEMI, NSTEMI 2 [1,8 %] Vessel disease

ANGIOGRAPHIC DATA LAD RCA 37% 41%41%41%41% LCx 17% others 5% Lesion type C 9% B2 39% A 10% Direct stenting: n = 74 Predilatation:n = 31 Success rate:100% B1 42% Calcification (moderate to severe)10% Thrombus1% Eccentric70% Angulation < % % Lesion location

CLINICAL OUTCOME 0-1 month1-6 month6-9 monthTotal 0-9 month Any MACE1113 (2.7%) Death0000 MI0101 (0,9%) Acute stent thrombosis1001 (0,9%) Clinically driven TLR1113 (2,7%)

ANGIOGRAPHIC DATA Before procedure After procedure Follow up 9months (n=90) Reference diameter (mm) 2.90 ± ± ± 0.4 MLD (mm)1.09 ± ± ± 0.6 Lesion length (mm)13.94 ± ± ± 4.2 % DS.62.8 ± ± ±18.4 Acute Gain (mm)-1.55 ± Late loss (mm) ±0.5

DISTRIBUTION OF STENOSIS SEVERITY Percent diameter stenosis after 9 months

BINARY RESTENOSIS RATE AT 9 MONTHS 10% Focal4 In-stent4 Diffuse1 Occlusive0 Patterns of in-stent restenosis (Mehran classification) Risk of restenosis in relation to type of lesion 11,1% 15,8% 5,7% 0% Restenosis rate

LUC vs OTHER DES’s Comparison Among DES Trials Late Loss Comparison Among DES TRIALS Binary Restenosis (In Stent)

LUC vs OTHER DES’s Comparison Among DES Trials MACE

SUMMARY Excellent procedural outcome with device success 100% Excellent procedural outcome with device success 100% Low MACE rate over 9 months after implantation (2.7%) Low MACE rate over 9 months after implantation (2.7%) Favorable late (9 months) angiographic results: Favorable late (9 months) angiographic results: - Binary restenosis 10,0% - Late loss 0.45 mm