title: Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions.
abstract: BACKGROUND
  Drug-eluting stents have been shown to be very effective in the treatment of coronary artery disease. In this independent, single-centre registry we assess the safety and efficacy of the sirolimus-eluting stent versus bare-metal balloon expandable stent for symptomatic infrapopliteal obstructions.
  
  
  RESULTS
  A total of 60 consecutive patients with infrapopliteal arterial obstructions were treated by stent implantation into the tibial and peroneal arteries and the data was entered into a prospective registry. All patients were treated with balloon-expandable coronary stents with a stent length of 33 mm and a nominal diameter of 3.5 mm. Enrolment was limited to patients treatable with a single stent. 30 patients (56.7% male, mean age 71.4 years, 83.3% diabetics) received a sirolimus-eluting balloon-expandable stent. 30 patients (63.3% male, mean age 73.0 years, 76.6% diabetics) were treated with uncoated bare-metal stents. At follow-up, the cumulative rates of Major Adverse Events were 10.0% vs. 46.6%. The rates of major amputation, bypass surgery or Target Lesion Revascularisation (TLR) were all zero for the sirolimus group compared with 10.0%, 0% and 23.3% in the bare metal stent group. There were 7 deaths (sirolimus =3, bare metal =7). Angiographic follow-up comparing sirolimus vs. bare metal revealed stent occlusion 0% vs. 17.4%, restenosis >50% of 0% vs. 39.1% (p 0.0007) and mean degree of in-stent restenosis of 1.8+/-4.8% vs. 53+/-40.9% (p <0.0001) respectively.
  
  
  CONCLUSIONS
  In this registry sirolimus-eluting stents were shown to be safe and effective in the treatment of focal infrapopliteal obstructions.
authors.affiliation: Department of Angiology; University of Leipzig - Heart Center, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Mathias
authors.initials: M
authors.lastname: Ulrich
authors.forename: Susanne
authors.initials: S
authors.lastname: Scheinert
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Sax
authors.forename: Sven
authors.initials: S
authors.lastname: Bräunlich
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Biamino