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LEADERS: Biodegradable polymer BES noninferior to durable polymer SES at 4 years
Stefanini G. Lancet. 2011;378:1940-1948.
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Biodegradable polymer biolimus-eluting stents significantly reduced the risk for cardiac events associated with very late stent thrombosis and improved clinical outcomes up to 4 years vs. durable polymer sirolimus-eluting stents, according to new data from the LEADERS study.
One hundred sixty patients (19%) with biodegradable polymer biolimus-eluting stents (BES) experienced the primary endpoint of cardiac death, MI or clinically indicated target vessel revascularization vs. 192 patients (23%) with durable polymer sirolimus-eluting stents (SES; rate ratio=0.81; 95% CI, 0.66-1.00). One to 4 years after implantation of biodegradable polymer BES, researchers found a lower risk for very late stent thrombosis compared with durable polymer SES (rate ratio=0.20; 95% CI, 0.06-0.67). According to study results, patients treated with biodegradable polymer BES had a yearly rate of 0.12% of very late stent thrombosis, whereas patients treated with durable polymer SES had a 0.6% yearly rate.
Researchers found a steady increase of very late stent thrombosis among early-generation durable polymer drug-eluting stents during long-term follow-up vs. bare metal stents. This difference is “especially apparent in complex patients, such as those with acute MI, multivessel disease, diabetes and bifurcation lesions.”
“Biodegradable polymer drug-eluting stents were designed to diminish long-term adverse events related to the persistence of durable polymers after completion of drug-release,” the researchers wrote. “[Results of the LEADERS trial] are in line with other randomized trials that compared biodegradable polymer drug-eluting stents with durable polymer sirolimus-eluting stents.”
“This study showed that the problem of very late stent thrombosis, which was prevalent with first-generation durable-polymer drug-eluting stents, is markedly reduced by a stent using a biodegradable polymer,” Stephan Windecker, MD, of University Hospital in Bern, Switzerland, said in a press release. “This translates into a late benefit in terms of cardiac death or MI.”
The head-to-head, randomized trial compared two limus-eluting stents — a biodegradable polymer BES (BioMatrix Flex, Biosensors) and a durable polymer SES (Johnson & Johnson). The study involves an all-comers patient population and measures clinical outcomes. The primary endpoint from LEADERS, published in The Lancet in 2008, demonstrated that the BES was noninferior to Cypher Select (Cordis) with respective to the primary endpoint (incidence of major adverse coronary events) at 9 months. This noninferiority has been confirmed in the 1-, 2-, 3- and 4-year results, during which time a diverging trend toward a safety benefit for the BES was observed.
Disclosure: Dr. Juni is an unpaid steering committee or statistical executive committee member of trials funded by Abbott Vascular, Biosensors, Medtronic and Johnson & Johnson. Dr. Eberli has received an institutional grant from Biosensors and consulting fees from Cordis. Dr. Wijns has received institutional research grants from Biosensors and Cordis, and was co-chairman of Cordis international advisory board. Dr. Eerdmans is an employee of Biosensors Europe.
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