Presentation on theme: "As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel."— Presentation transcript:
As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel In-Stent Controlled Elution Study 4 and 12-Month Results
Bridge Elements Reservoirs Reservoirs Ductile Hinges CoStar™ Stent Design CoStar ™ Paclitaxel-Eluting Coronary Stent System Clinical Trials A Stent Designed Specifically for Controlled and Targeted Drug Delivery
Conor Stainless Steel and Cobalt Chromium Stents Characteristic MedStent* Stainless Steel CoStar ™ Cobalt Chromium Design576 Reservoirs (17mm stent) 492 Reservoirs (17mm stent) Alloy316L Stainless SteelL605 Cobalt Chromium Strut Thickness0.0051 inch0.0035 inch Crossing Profile (3.0mm Stent) 0.046 inch0.039 inch RadiopacityExcellent Polymer Type85/15 PLGA Polymer Volume515 µg347 µg * MedStent was the study stent for the PISCES trial
PISCES – Paclitaxel In-Stent Controlled Elution Study Study Purpose: To evaluate safety and performance of the Conor MedStent ™ and determine optimal dosing of Paclitaxel in a prospective, multi-center, sequentially enrolled study involving 6 different release formulations. The proposed intended use of the MedStent is to improve and maintain arterial lumen diameter in patients with ischemic heart disease in native coronary arteries with de novo lesions.
PISCES Trial Study Design & Patient Follow-Up * Bi-Directional = direction of paclitaxel elution is both mural and luminal + 12 Month Angiography w/ QCA and IVUS was optional D 1 D 1 10 µg / 5 days Bi-Directional* Release N = 30 patients D 2 10 µg / 10 days Mural Release N = 30 patients D 3 10 µg / 10 days Bi-Directional* Release N = 29 patients D 4 10 µg / 30 days Mural Release N = 39 patients D 5 30 µg / 30 days Mural Release N = 29 patients D 6 30 µg / 10 days Bi-Directional* Release N = 30 patients Treatment Arms 1 Month Clinical 4 Month Clinical 4 Month Angiographic with QCA & IVUS 1 Year Clinical Baseline Angiography Baseline Angiography 12 Month Angiographic with QCA & IVUS + Dose Ranging Study
PISCES Trial Study Endpoints Safety Endpoint: A composite of MACE at 4 months Efficacy Endpoints: Late Loss by QCA within the stent % Stent Volume Obstruction by IVUS Rate of Binary Restenosis The data is presented as “intent to treat”.
Participating Investigators & Centers 31RotterdamP.W. Serruys 1KreuzlingenM. Pieper 23EindhovenH. Bonnier 12Rotterdam ZuidA. G. de Vries 7CaracasJ. A. Condado 191 Total 8Buenos AiresJ. Belardi 10AntwerpS. Verheye 11New ZealandD. McClean 26BredaP. den Heijer 62Sao Paolo J. E. Sousa / A. Abizaid Patients EnrolledSite LocationInvestigator
Number of Patients191 Patients Total Lesions Treated187 Lesions Total Number of CoStar ™ Stent Implanted209 Stents Average Number of Stents per Patient1.1 Average Number of Stents per Lesion1.1 Direct Stenting per Lesion51.0% Procedural Success92.7% Device / Technical Success95.3% PISCES Trial Procedural Data
N = 191 Patients Age in Years (mean ± SD) 59.1 ± 9.2 Gender (% Male) 70.2 (134) History of Smoking 76.0% (145) Diabetes Mellitus 18.8% (36) Hypertension 52.9% (101) Dyslipidemia 66.0% (126) Prior MI 38.2% (73) Prior CABG 2.6% (5) Prior PCI 12.0% (23) PISCES Trial Baseline Patient Demographics
In-Stent Binary Restenosis at 4 and 12 Months Cumulative % 00 5.6 N=18 N=32 5.6 10/30/m30/30/m
In-Stent Late Loss at 4 Months (mm) N=26 N=38 N=43 N=29 N=28N=28 N=29 10/5/b10/10/bBare10/10/m 10/30/m 30/10/b30/30/m
(mm) In-Stent Late Loss at 4 and 12 Months Serial Analysis 0.40 0.32 0.52 0.36 p=0.01 p=0.53 N=32N=18 Late loss of patients undergoing TLR at 4 months (D5=0, D6=1) is imputed as the value of late loss at 12 months.10/30/m30/30/m
In-Stent % Volume Obstruction at 4 and 12 Months Serial Analysis % 7 6 12 8 p=0.0004p=0.31 N=15 N=30 10/30/m30/30/m
MACE at 4 and 12 Months % 8 17.2 20.7 6.7 13.3 6.7 10 2.6 5.1 3.4 6.9 Between 4 and 12 months, 1 non Q-wave MI occurred in D5 in a non- target vessel and 1 Q-wave MI (total occlusion of target lesion) in D6. 16.7 10/5/b10/10/bBare10/10/m 10/30/m 30/10/b30/30/mN=29 N=39 N=50 N=30 N=30N=29 N=30
Proximal and Distal Edge Late Loss at 4 and 12 Months - Serial Analysis p=0.44 p=0.97 p=0.10 p=0.69 D5 D6 0.22 0.27 0.11 0.10 0 0.2 0.4 0.6 0.8 1 proximaldistal
Conclusions This study represents one of the most comprehensive analyses of pharmacokinetic releases ever performed in a FIM Study. The safety profile of this system - using an erodable polymer and delivering 100% of the drug is within the accepted standards. Protocol called for 6 months Plavix therapy. There were no reported cases of delayed stent thrombosis in the interval period. Although the doses used were substantially less than paclitaxel-coated stents, the inhibition of neo-intimal hyperplasia was similar.
Conclusions In the 2 long release (most effective) formulations the TLR and MACE rates remained low at 12 months. In D5, there was 0% in stent restenosis at both 4 and 12 months and in D6 the restenosis rate remained 5.6%. There was a modest but statistically significant increase in neo-intimal volume, % in-stent obstruction and late loss between 4 months and 12 months in D5 but not in D6. The TLR and restenosis rates in the D6 group were not as good as in D5. These 2 pharmacokinetic profiles are currently under investigation in the Eurostar trial with a thin strut cobalt chromium stent and 33% less polymer volume.