Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings

Am J Cardiol. 2007 Jun 15;99(12):1691-7. doi: 10.1016/j.amjcard.2007.01.043. Epub 2007 May 7.

Abstract

Percutaneous intervention for coronary bifurcation lesions has been associated with increased clinical complication rates compared with nonbifurcation lesions, primarily as a result of restenosis. Therefore, there is a need for new techniques. The purpose of this study was to evaluate a new drug-eluting stent and implantation technique for the treatment of de novo coronary bifurcation lesions. The Axxess Plus trial was a prospective multicenter single-arm study that enrolled 139 patients. Each patient received a self-expanding, conically shaped nickel-titanium Axxess Plus biolimus A9-eluting stent at the level of the carina. Depending on the lesion anatomy, additional nonstudy stents were placed distally if necessary. Clinical and angiographic follow-up were scheduled at 6 months after the procedure. The overall rate of target lesion revascularization was 7.5% at 6 months. A mean of 2.4 stents were implanted per patient; 51.2% of patients received a stent to the side branch, 29.4% received balloon angioplasty only, and 20.6% of side branches were not treated. In-stent late loss in the Axxess stents was 0.09 mm. Incidences of angiographic in-stent restenosis were 7.1% in the parent vessel stents and 9.2% in the group receiving stents in the side branch (7.9% excluding bare metal stents placed distal to the Axxess stent), compared with 25% for balloon angioplasty treatment and 12% for no treatment. Late stent thrombosis was observed in 3 cases, 2 of which were associated with confirmed premature cessation of antiplatelet therapy. In conclusion, the Axxess Plus conical stent effectively treats bifurcation lesions alone or in conjunction with other drug-eluting stents.

Publication types

  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Aged
  • Antibiotics, Antineoplastic / therapeutic use*
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Coronary Angiography
  • Coronary Stenosis / surgery
  • Coronary Vessels / anatomy & histology
  • Coronary Vessels / surgery*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use
  • Stents*

Substances

  • Antibiotics, Antineoplastic
  • umirolimus
  • Sirolimus