September 2, 2008 (Munich, Germany) - A drug-eluting stent with a biodegradable polymer fared just as well as an older-generation sirolimus-eluting stent from a durable polymer in patients with stable coronary artery disease or acute coronary syndromes in the Limus Eluted from a Durable versus Erodable Stent Coating (LEADERS) trial, presented at the ESC 2008 meeting in Munich.
The biolimus-eluting stent (BIOMATRIX) is a new DES releasing biolimus, a sirolimus analogue, from a biodegradable polymer, polylactic acid, which completely degrades into carbon dioxide and water during a period of 6-9 months. This new stent platform was compared against a widely used sirolimus-eluting stent (CYPHER) with durable polymer in 1707 patients with 2472 lesions with both on- and off label characteristics in the randomized, multi-centre, single-blind, non-inferiority LEADERS trial.
├óÔé¼┼øThe biolimus-eluting stent with an abluminal biodegradable polymer compared against the sirolimus-eluting stent with a durable polymer resulted in noninferior safety, efficacy, and angiographic outcomes at nine months,├óÔé¼┼Ñ said lead investigator Dr Stephan Windecker (Bern University Hospital, Switzerland).
Nine months after the procedure, the numbers of cardiac death, MI, or clinically indicated TVR were equivalent in both treatemnt groups (9.2% of patients treated with biolimus stent and 10.5% of patients treated with the sirolimus-eluting stent) meeting the statistical definition of noninferiority.
Data on stent-thrombosis rates at 30 days and at 9 months the occurence of stent thrombosis between the two patient groups showed a nonsignificant difference. In the one in four patients given an angiogram, the degree of blood vessel narrowing at the site of stent implantation was also equivalent in both treatment groups.
Biolimus is a semi-synthetic analog of sirolimus with enhanced lipophilicity that is coupled to a polylactic acid biodegradable polymer. In-vivo studies suggest that this polymer is fully converted to lactic acid within 6 to 9 months, leaving the stainless steel stent. Attractive features of this stent include better deliverability and a biodegradable polymer, which might help attenuate late stent thrombosis. Although the incidence of stent thrombosis from 30 days to 9 months was low and similar between the groups, the occurrence of very late stent thrombosis will need to be carefully monitored.