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Problem

Problem. The treatment of stenoses of small coronary arteries (SVD) and of restenoses after stent deployment (ISR) still show unsatisfactory long-term results even after drug-eluting stent deployment. Likely Solution. Using a drug-eluting balloon catheter (B.Braun Melsungen AG, Germany).

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Problem

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  1. Problem The treatment of stenoses of small coronary arteries (SVD) and of restenoses after stent deployment (ISR) still show unsatisfactory long-term results even after drug-eluting stent deployment Likely Solution Using a drug-eluting balloon catheter (B.Braun Melsungen AG, Germany)

  2. Paclitaxel-eluting stent (DES) vs. Paclitaxel-eluting balloon (DEB) DES Hwang, Circulation 2001; 104: 600-5 Paccocath Scheller, Heart 2007; 2007;93:539-41

  3. The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease PEPCAD I-SVD PEPCAD II-ISR Martin Unverdorben Clinical Research Institute, Center for Cardiovascular Diseases Rotenburg an der Fulda, Germany On behalf of the PEPCAD Investigators

  4. Primary Variable • 6-month late lumen loss Secondary Variables • Procedural success (≤30% stenosis) • 6-month binary restenosis rate • 6-month MACE • MACE at 1 and 3 years

  5. Outcome Comparison *Stone, G JAMA 2005;294:1215-23

  6. Summary PEPCAD I • The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … • was safe and associated with a high procedural success rate in de-novo lesions • exhibited low late lumen loss after 6 months in SVD • patients treated w/o additional stenting demonstrated a restenosis rate of 5.5%

  7. PEPCAD IIRandomized Comparison to Taxusin ISR

  8. Primary Variable • 6-month late lumen loss Secondary Variables • Procedural success (≤30% stenosis) • 6-month binary restenosis rate • 6-month MACE • MACE at 1 and 3 years

  9. As-Treated Groups Enrolled 131 Subj. Conventional balloon 1 Subj. Violator from DES

  10. Outcome (N=126) 2 NSTEMI side branch occlusion 4 non-cardiac death 1 1 protocol violators excluded 3cardiac, not lesion related

  11. Event Free Survival (ITT/As Treated) p=0.07 ITT p=0.007 As Treated Months post PCI

  12. Summary PEPCAD II • The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … • was safe and associated with a high procedural success rate in ISR • exhibited low late lumen loss after 6 months in ISR • was superior to the paclitaxel-eluting Taxus stent in ISR after 6 months • has not been associated with late thrombosis in 200 patient years in SVD and ISR

  13. Additional Handouts

  14. Abbreviations and Terms

  15. Abbreviations and Terms

  16. Contact Information Martin Unverdorben MD, PhD, Associate Professor of Medicine +1 804 651 3089 (EST)  sbu135@comcast.net

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