Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions

Am J Cardiol. 2006 Aug 15;98(4):443-6. doi: 10.1016/j.amjcard.2006.02.051. Epub 2006 Jun 23.

Abstract

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Coated Materials, Biocompatible*
  • Coronary Angiography*
  • Coronary Stenosis / diagnostic imaging*
  • Coronary Stenosis / surgery
  • Feasibility Studies
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Prospective Studies
  • Sirolimus / analogs & derivatives
  • Sirolimus / therapeutic use*
  • Stents*
  • Treatment Outcome

Substances

  • Coated Materials, Biocompatible
  • Immunosuppressive Agents
  • Sirolimus