Long-term Outcomes Improved with Biodegradable Biolimus-Eluting Stent vs. Permanent Polymer SES

SAN FRANCISCO, CALIF.—Four-year data from the prospective, randomized LEADERS trial demonstrated that a biodegradable polymer biolimus-eluting stent (BES) may improve long-term clinical outcomes compared with a durable polymer sirolimus-eluting stent, according to results presented at TCT 2011.

These results were attributed to a reduced risk of cardiac events due to a significantly lower rate of very late stent thrombosis with the  biodegradable stent (Biolimus A9, Biosensors International), Thomas Ischinger, MD, PhD, with Kardiologie im Zentrum, in Munich, Germany, said during his presentation.

LEADERS was a multicenter, randomized trial conducted at 10 European centers between November 2006 and May 2007. Researchers randomly allocated 1,707 CAD patients with 2,472 lesions to receive either BES or SES. The primary endpoint was a composite of cardiac death, MI or target vessel revascularization. The researchers simultaneously published their findings in The Lancet on Tuesday.

Benefit driven by low rate of MI

Ischinger further explained that previously published data have shown comparability between the two stent types regarding MACE rates, but the most recently published data show that the benefit was more pronounced between years 1 and 4 in the BES group.

“This benefit from 1 year to 4 years actually appears largely driven by a lower rate of MI,” Ischinger told the TCT audience. He noted the risk of MACE was lower in patients treated with BES than in those treated with SES (18.7% vs. 22.6%; P=.05). 

Ischinger noted a trend for a lower frequency of ARC-defined definite ST with the biodegradable polymer stent (see Figure).

 “When you look at cardiac events associated with definite ST through 4 years, we do see a clear benefit with BES,” he added.

An analysis of the correlation between ST and MACE demonstrated that the benefit with BES was largely driven by a lower risk of MACE associated with definite very late stent thrombosis beyond the first year of follow-up.