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.

METHODS AND 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.

CONCLUSION:

In this registry sirolimus-eluting stents were shown to be safe and effective in the treatment of focal infrapopliteal obstructions.

• Authors: Dierk Scheinert, Mathias Ulrich, Susanne Scheinert, Jacqueline Sax, Sven Bräunlich, Giancarlo Biamino
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 2 Issue 2 Pg. 169-74 (Aug 2006) ISSN: 1774-024X [Print] France
• PMID: 19755256 (Publication Type: Journal Article)