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

Copyleft Clinical Trial Results. You Must Redistribute Slides

PEPCAD II ISR StudyPEPCAD 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

Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease

PEPCAD II ISR Study

Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease

PEPCAD II ISR Study

Presented at ACC / i2 2008 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


PEPCAD II ISR Study: BackgroundPEPCAD 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).

• Using 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™ DEB



PEPCAD II ISR STUDY: The Matrix Coating

PEPCAD II ISR STUDY: The Matrix Coating

PACCOCATH technology creates a unique matrix coatingPACCOCATH technology creates a unique matrix coating

WithoutWithout With PACCOCATH technologyWith 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 wallUniform/complete application of the drug after 1st 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 wallUniform/complete application of the drug after 1st balloon

expansionFrom M. Unverdorben: ACC 2008From M. Unverdorben: ACC 2008



PEPCAD II ISR Study: SeQuent™PEPCAD II ISR Study: SeQuent™

*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

*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 2008From M. Unverdorben: ACC 2008



DES• Slow and continuous drug

release from stent struts

• ~100 -200 μg Paclitaxel / Sirolimus

• polymers with associated reactions

• Implies stent deployment DES

DEB (PACCOCATH)• Instant and short term drug

release from balloon

• ~ 300 -600 μg Paclitaxel

• No polymers

• No permanent mechanical irritation

• Stenting optional DEB

PEPCAD II ISR Study: SeQuent™DES vs. DEB

PEPCAD II ISR Study: SeQuent™DES vs. DEB


PEPCAD II ISR Study: Study DesignPEPCAD 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™ PleaseDrug Eluting Balloon Catheter

n=66

131 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


Taxus Drug Eluting Stent

n=65


PEPCAD II ISR Study: Event Free Survival (ITT/As Treated)



PEPCAD II ISR Study: 12 Month Follow-up Study Design

PEPCAD II ISR Study: 12 Month Follow-up Study Design


Follow-up12.3 ± 0.7 months

59/60 (98.3%)

DEB n=66 :DEB only n=56

DEB + BMS n=6DEB (cross over) n=4

Unknown today1/66 (1.5%)

Deaths2/66 (3.0%)

Lost to FU0/66 (0%)

Follow-up12.3 ± 0.8 months

57/60 (95%)

DEB n=60 :Additional DES n=2

Unknown today2/60 (3.3%)

Deaths3/60 (5%)

Lost to FU1/60 (0.0%)





DEB (n= 66) DES (n=60) P value=

Follow-up: clinical [months] 6.2 ± 0.8 6.2 ± 0.8 0.7Follow-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 ± 0.38 0.47 ± 0.71 0.03Binary restenosis in segment 2/58 (3.4%) 11/54 (20.4%) 0.007TLR 2/64 (3.1%) 10/60 (16.7%) 0.02Myocardial infarction 0/64 (0.0%) *1/60 (1.7%) 1Death **2/64 (3.1%) ***1/60 (1.7%) 1Total MACE (w/o noncardiac death) 3/64 (4.7%) 11/60 (18.3%) 0.02

PEPCAD II ISR Study: Outcomes (AsT:N=126)

PEPCAD II ISR Study: Outcomes (AsT:N=126)


*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



PEPCAD II ISR Study: LimitationsPEPCAD II ISR Study: Limitations

• This 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 setting

• Further long-term results on this trial are awaited



PEPCAD II ISR Study: SummaryPEPCAD 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 2008From M. Unverdorben: ACC 2008


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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