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Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please.

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Presentation on theme: "Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please."— Presentation transcript:

1 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please balloon catheter versus the TAXUS stent in the treatment of in-stent restenosis – 12 month follow-up of the PEPCAD II ISR study Presented at SCAI-i2 summit 08

2 Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease PEPCAD II ISR Study Presented at ACC / i in Chicago Presented by Dr. Martin Unverdorben PEPCAD II ISR Study Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI-i2 summit 08

3 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study: Background Significant restenosis rates in coronary arteries exist despite the use of drug eluting stents (DES) - especially in high risk lesions such as restenoses after bare-metal stent deployment (instent restenosis ISR).Significant restenosis rates in coronary arteries exist despite the use of drug eluting stents (DES) - especially in high risk lesions such as restenoses after bare-metal stent deployment (instent restenosis ISR). Using a drug-eluting balloon catheter (DEB) is a possible solution for treating ISRUsing a drug-eluting balloon catheter (DEB) is a possible solution for treating ISR PEPCAD II ISR is looking at the safety and efficacy of the SeQuent Please™ DEBPEPCAD II ISR is looking at the safety and efficacy of the SeQuent Please™ DEB Presented at SCAI-i2 summit 08

4 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR STUDY: The Matrix Coating PACCOCATH technology creates a unique matrix coating WithoutWithout With PACCOCATH technology  High bioavailability of paclitaxel at the target site for rapid drug absorption by the vessel wall  Huge contact surface between lipophilic drug and vessel wall  Uniform/complete application of the drug after 1 st balloon expansion  High bioavailability of paclitaxel at the target site for rapid drug absorption by the vessel wall  Huge contact surface between lipophilic drug and vessel wall  Uniform/complete application of the drug after 1 st balloon expansion From M. Unverdorben: ACC 2008 Presented at SCAI-i2 summit 08

5 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study: SeQuent™ PACCOCATH *SeQuent®Please (B.Braun Vascular Systems, Berlin, Germany) is manufactured based on the PACCOCATH technology with 3μg paclitaxel/mm²; CE mark in the EU filedSeQuent From M. Unverdorben: ACC 2008 Presented at SCAI-i2 summit 08

6 Copyleft Clinical Trial Results. You Must Redistribute Slides DES Slow and continuous drug release from stent struts ~ μg Paclitaxel / Sirolimus polymers with associated reactions Implies stent deployment DES DEB (PACCOCATH) Instant and short term drug release from balloon ~ μg Paclitaxel No polymers No permanent mechanical irritation Stenting optional DEB PEPCAD II ISR Study: SeQuent™ DES vs. DEB Presented at SCAI-i2 summit 08

7 PEPCAD II ISR Study: Study Design  Primary Endpoint: 6 month late lumen loss  Secondary Endpoint: Procedural success (≤30% stenosis), 6 month binary restenosis, 6 month MACE, MACE at 1 and 3 years SeQuent™ Please Drug Eluting Balloon Catheter n= patients > 18 years eligible for coronary revascularization for instent restenosis by means of PCI Prospective. Randomized. Multi-center. Two-arm Phase-II Pilot Study R 6 month, 1 and 3 year follow-ups 6 month, 1 and 3 year follow-ups Copyleft Clinical Trial Results. You Must Redistribute Slides Taxus Drug Eluting Stent n=65 Presented at SCAI-i2 summit 08

8 PEPCAD II ISR Study: Event Free Survival (ITT/As Treated) Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI-i2 summit 08

9 PEPCAD II ISR Study: 12 Month Follow-up Study Design Copyleft Clinical Trial Results. You Must Redistribute Slides Follow-up 12.3 ± 0.7 months 59/60 (98.3%) DEB n=66 : DEB only n=56 DEB + BMS n=6 DEB (cross over)n=4 Unknown today 1/66 (1.5%) Deaths 2/66 (3.0%) Lost to FU 0/66 (0%) Follow-up 12.3 ± 0.8 months 57/60 (95%) DEB n=60 : Additional DES n=2 Unknown today 2/60 (3.3%) Deaths 3/60 (5%) Lost to FU 1/60 (0.0%) Presented at SCAI-i2 summit 08

10 PEPCAD II ISR Study: Event Free Survival (ITT/As Treated) Copyleft Clinical Trial Results. You Must Redistribute Slides Presented at SCAI-i2 summit 08

11 DEB (n= 66) DES (n=60) P value= Follow-up: clinical [months] 6.2 ± Follow-up: clinical [n] 64 (97.0%) 60 (100%) 0.4 Follow-up: angiographic 58 (87.9%) 54 (90.0%) 0.8 Late lumen loss [mm] 0.19 ± ± Binary restenosis in segment 2/58 (3.4%) 11/54 (20.4%) TLR 2/64 (3.1%) 10/60 (16.7%) 0.02 Myocardial infarction 0/64 (0.0%) *1/60 (1.7%) 1 Death **2/64 (3.1%) ***1/60 (1.7%) 1 Total MACE (w/o noncardiac death) 3/64 (4.7%) 11/60 (18.3%) 0.02 PEPCAD II ISR Study: Outcomes (AsT:N=126) Copyleft Clinical Trial Results. You Must Redistribute Slides *NSTEMI due to side branch occlusion **1 cardiac, not lesion related; 2 non cardiac *** non-cardiac death *NSTEMI due to side branch occlusion **1 cardiac, not lesion related; 2 non cardiac *** non-cardiac death Presented at SCAI-i2 summit 08

12 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study: Limitations This study consisted of a relatively small number of patientsThis study consisted of a relatively small number of patients In addition, this study consisted of patients with instent-restenosis only. Its wider applicability among patients with de novo coronary artery lesions requires further research in a randomized settingIn addition, this study consisted of patients with instent-restenosis only. Its wider applicability among patients with de novo coronary artery lesions requires further research in a randomized setting Further long-term results on this trial are awaitedFurther long-term results on this trial are awaited Presented at SCAI-i2 summit 08

13 Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study: Summary In the treatment of ISR, the paclitaxel-eluting balloon catheter SeQuent™ Please (B. Braun Melsungen AG)… –Was safe and associated with a high procedural success rate –Exhibited a significant reduction in 6 month late lumen loss and 12 month MACE when compared to the Taxus™ stent, and –Was not associated with late thrombosis in > 250 patient years From M. Unverdorben: ACC 2008 Presented at SCAI-i2 summit 08


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