Biolimus Stents Noninferior to Sirolimus StentsLast Updated: November 09, 2011. Biodegradable biolimus-eluting stents are noninferior to durable polymer sirolimus-eluting stents in coronary artery disease, according to a study published online Nov. 9 in The Lancet to coincide with its presentation at the Transcatheter Cardiovascular Therapeutics meeting, held from Nov. 7 to 11 in San Francisco.
WEDNESDAY, Nov. 9 (HealthDay News) -- Biodegradable biolimus-eluting stents (BES) are noninferior to durable polymer sirolimus-eluting stents (SES) in coronary artery disease (CAD), according to a study published online Nov. 9 in The Lancet to coincide with its presentation at the Transcatheter Cardiovascular Therapeutics meeting, held from Nov. 7 to 11 in San Francisco.
Giulio G. Stefanini, M.D., from the University of Bern in Switzerland, and colleagues compared the clinical outcomes of BES and SES during long-term (four years) follow-up of 1,707 patients with CAD. Cohorts of 857 and 850 patients were randomized to receive BES and SES, respectively, between Nov 2006 and May 2007. A composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization was the primary end point.
The investigators found that, at the four-year follow-up point, BES was noninferior to SES with respect to the primary end point (rate ratio [RR], 0.81; P for noninferiority <0.0001, P for superiority = 0.050). Definite stent thrombosis (ST) had a RR of 0.62, largely due to the BES group having a significantly lower risk very-late definite ST risk between years one and four compared to the SES group (RR, 0.20). During the first year, the RR of definite ST was not significant (0.99). There was a positive test for the interaction between RR of definite ST and time; an interaction with time was recorded for events linked to ST, but not other events. The RRs for the primary end point events associated with ST were 0.86 and 0.17 during the first and subsequent years, respectively (Pinteraction = 0.049).
"Compared with durable polymer SES, biodegradable polymer BES are noninferior," the authors write.
Several of the study authors disclosed financial ties with the pharmaceutical and medical device industries, including Biosensors Europe, which funded the study and manufactures drug eluting and bare metal stents.