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Bruno Scheller for the Paccocath ISR Study Group

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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Bruno Scheller for the Paccocath ISR Study Group

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  1. 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

  2. Drug-Eluting Balloon (DEB) • 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

  3. Paccocath ISR I/II 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

  4. Paccocath ISR I/II • 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)

  5. Paccocath ISR I/II – Patient Characteristics p-values adjusted according to Fisher’s method of combining independent tests

  6. Paccocath ISR I/II - Lesions p-values adjusted according to Fisher’s method of combining independent tests

  7. Paccocath ISR I/II - Intervention p-values adjusted according to Fisher’s method of combining independent tests

  8. Paccocath ISR I/II Angiographic measurements at treatment p-values adjusted according to Fisher’s method of combining independent tests

  9. Paccocath ISR I/II Angiographic measurements at follow-up angiography p-values adjusted according to Fisher’s method of combining independent tests

  10. Paccocath ISR I/II 24 month Clinical follow-up Intention-to-treat analysis; p-values adjusted according to Fisher’s method of combining independent tests

  11. Paccocath ISR I/II - MACE 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

  12. Paccocath ISR I vs. II

  13. Paccocath ISR I vs. II Late lumen loss in-segment

  14. Conclusions • 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.

  15. DEB - clinical applications • 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

  16. Paccocath ISR Study Group • 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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