PEACE

PEACE

Pulsar efficacy - An all-comers registry: 12-month results 1

Conclusion

  • Pulsar stents showed favorable study results at 12 months in patients with an average lesion length of 11.2 cm
  • A primary patency (PP) at 12 months of 79.5% and Freedom from Target Lesion Revascularization (FTLR) of 81%
  • Results are similar to published data of similar lesion lengths, including 4EVER (Pulsar-18) with a PP of 73.4% and a FTLR of 85.2%
  • No significant difference between TASC A/B vs. TASC C/D lesions (p = 0.55) and diabetics vs. non-diabetics (p = 0.92)

Patient Demographics

Bild
Picture shows patient demographics
Bild
Picture shows lesion characteristics

Study Design

  • Multi-center, prospective all-comers registry
  • Number of patients (n): 1482
  • Primary investigators: Dr. Michael Lichtenberg, Arnsberg, Germany and Prof. Dr. Günther Wittenberg, Bielefeld, Germany
  • Endpoints: PP3 at 6 and 12 months and FTLR
  • Follow-up at 6 and 12 months
  • Participating centers: Dr. B Hailer, Essen, Germany; Dr. Claus Nolte-Ernsting, Mülheim, Germany; Dr. Christiane Tiefenbacher, Wesel, Germany; Dr. Jawed Arjumand, Wuppertal, Germany; Dr. Michael Lichtenberg, Arnsberg, Germany; Dr. Günther Wittenberg, Bielefeld, Germany
Bild
Picture shows study design

Results

Bild
Picture shows study results

PEACE Primary Patency and Freedom from TLR in Perspective

Bild
Picture shows study results

Downloads


Bild
BIOTRONIK 4 F system Passeo-18

Vascular Intervention

Self-expanding StentOne-handed stent release for accurate stent deployment

Bild
Picture shows Pulsar-35

Vascular Intervention

Self-expanding StentTri-axial shaft for a stable delivery system during stent deployment


Sources:
1 Lichtenberg M. JEVT. 2014; 21: 373-380.
2 30 patients were lost before 12-month follow-up (18 declined re-evaluation, five withdrew consent and seven died)
3 Defined as binary duplex ultrasound PSVR < 2.5 at the stented target lesion(s) and freedom from Target Lesion Revascularization (FLR)

USA: Not for sale - Investigational Device.
Limited by United States Law to Investigational Use.

© BIOTRONIK AG
All rights reserved. Specifications are subject to modification, revision and improvement.