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TCT 2007 - Late Breaking Studies and First Report Investigations Wednesday, October 24 2007, Main area PACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results. Bruno Scheller for the Paccocath ISR Study Group.

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TCT 2007 - Late Breaking Studies and First Report InvestigationsWednesday, October 24 2007, Main areaPACCOCATH ISR 1 and 2: A Prospective, Randomized Trial of a Paclitaxel-Eluting Balloon in In-Stent Restenosis: 2-Year Results

Bruno Scheller

for the Paccocath ISR Study Group

Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg / Saar, Germany


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Drug-Eluting Balloon (DEB) Investigations

  • Drug-Eluting Stent

  • Slow release

  • Persistent drug exposure

  • ~ 100 - 200 µg dose

  • Polymer

  • Stent mandatory

  • Drug-Eluting Balloon

  • Immediate release

  • Short-lasting exposure

  • ~ 300 - 600 µg dose

  • No polymers

  • Premounted stent optional

Heart 2007, 93: 539-41


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Paccocath ISR I/II Investigations

Efficacy and Safety of Paclitaxel-Coated Balloons

in Coronary In-Stent Restenosis

Homburg/Saar, Freiburg, Charité Mitte Berlin,

Charité Virchow Berlin, Mannheim-Heidelberg

  • Two trials

    • separately randomized

    • double-blind, multicenter

    • identical protocol

    • 108 patients in total

  • Paccocath ISR I

    • 52 patients

  • Paccocath ISR II

    • 56 patients


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Paccocath ISR I/II Investigations

  • Primary endpoint

    • In-segment late lumen loss after 6 months

    • Independent, blinded angiographic core lab

      • U. Dietz, Wiesbaden

  • Secondary endpoints

    • Binary restenosis rate, MACE

  • Statistics

    • p-values adjusted according to Fisher’s method of combining independent tests

  • ASA + clopidogrel

    • 4 weeks in both groups

  • Main inclusion criteria

    • Clinically relevant coronary ISR

    • Diameter stenosis > 70 %

    • Lesion length < 30 mm

    • Vessel diameter 2.5 to 3.5 mm

  • Repeated PTCA of coronary ISR

    • Coated balloon with 3 µg paclitaxel / mm² balloon surface

    • Uncoated balloon of the same type (BMT, Oberpfaffenhofen)


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Paccocath ISR I/II – Patient Characteristics Investigations

p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II - Lesions Investigations

p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II - Intervention Investigations

p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II Investigations

Angiographic measurements at treatment

p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II Investigations

Angiographic measurements at follow-up angiography

p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II Investigations

24 month Clinical follow-up

Intention-to-treat analysis; p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I/II - MACE Investigations

TLR, MI, acute/subacute closure, stroke, or death

Mantel-Cox log-rank test; p-values adjusted according to Fisher’s method of combining independent tests


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Paccocath ISR I vs. II Investigations


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Paccocath ISR I vs. II Investigations

Late lumen loss in-segment


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Conclusions Investigations

  • First in man trial with a paclitaxel-coated balloon

  • Angiographic and clinical efficacy up to 24 months

  • Safety 24 months

    • no late thrombosis

    • clopidogrel only for one month

  • No coating-related adverse events

  • Inhibition of restenosis by drug-coated balloons does not require stent implantation and sustained drug release at the site of injury.


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DEB - clinical applications Investigations

  • Treatment of ISR

    • Paccocath ISR I/II

    • PEPCAD II

  • Small vessels

    • PEPCD I

  • Bifurcation lesions

    • PEPCAD V

  • DEB with pre-mounted stent

    • PEPCAD III

  • Peripheral artery disease

    • THUNDER

    • PACCOCATH FEM

  • Pediatric cardiology


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Paccocath ISR Study Group Investigations

  • Study centers

    • Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar (M. Böhm, B. Cremers, M. Kindermann, U. Laufs, T. Müller, B. Scheller, J. Schmidt, S. Siaplaouras; N. Hollinger, B. Werner)

    • Innere Medizin III, Medizinische Universitätsklinik, Freiburg i. Br. (Christoph Hehrlein; A. Becherer)

    • Kardiologie, Campus Virchow-Klinikum, Charité, Berlin (Wolfgang Bocksch, J. Waigand)

    • Kardiologie, Campus Mitte, Charité, Berlin (Wolfgang Rutsch; S. Schroeckh)

    • I. Medizinische Klinik, Universitätsklinikum, Mannheim-Heidelberg (Dariush Haghi, K. Haase, T. Süsselbeck)

  • Angiographic Core Lab

    • Deutsche Klinik für Diagnostik, Wiesbaden (Ulrich Dietz, K. Wilhelmi; Quantitative Coronary Angiography)

  • Pharmaceutical Development

    • Ulrich Speck; Charité, Berlin

  • Devices and Sponsoring

    • Bavaria Medizin Technologie, Oberpfaffenhofen

    • Bayer-Schering Pharma AG, Berlin


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