Similar outcomes with biodegradable versus durable polymer-coated stents
medwireNews: Results of the BIO-RESORT trial suggest that 1 year after percutaneous coronary intervention, stents with biodegradable polymer coating eluting either everolimus or sirolimus are noninferior to durable polymer-coated stents eluting zotarolimus.
Demonstration of 1-year safety and efficacy of the biodegradable polymer-coated stents “is a prerequisite before assessing their potential longer-term benefits,” write the study authors in The Lancet.
The primary endpoint of vessel failure – a composite of cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization – occurred in 5% of 1172 patients assigned to everolimus-eluting stents, 5% of 1169 assigned to sirolimus-eluting stents, and 5% of 1173 assigned to zotarolimus-eluting stents.
Researchers Clemens von Birgelen (Thoraxcentrum Twente, Enschede, the Netherlands) and colleagues note that with an absolute risk difference of −0.7% for both everolimus- and sirolimus- versus zotarolimus-eluting stents, “the two very thin strut drug-eluting stents with highly dissimilar biodegradable polymer coatings” were noninferior to “an established new-generation, durable polymer stent.”
The rate of definite stent thrombosis was also similar in those receiving the three stent types, occurring in 0.3% of patients in each group.
The BIO-RESORT trial included all-comer patients with coronary artery disease across four clinical sites in the Netherlands. A high proportion of patients (70%) were treated for acute coronary syndromes, and 72% of all coronary lesions treated were complex.
In an accompanying comment, Aloke Finn and Renu Virmani, both from CVPath Institute Inc., Gaithersburg in Maryland, USA, explain that “sustained exposure of the arterial wall to permanent polymer and limus drugs might cause long-term endothelial dysfunction,” and therefore the use of biodegradable polymer-coated stents “might reduce long-term drug exposure and further delay, if not prevent, neoatherosclerosis.”
Finn and Virmani write that the results of the BIO-RESORT trial “provide reassuring data that present generation bioresorbable polymer stents are at least as good as permanent polymer systems at short-term follow-up.”
They add: “[I]t might be challenging to show superiority at relatively short-term follow-up given the excellent performance of newer generation permanent polymer drug-eluting stents.”
The study authors believe that the potential benefits or harms of biodegradable polymer-coated stents may become evident after a year, noting that “[t]he mid-term and long-term clinical outcome of these patients will also be of great interest.”
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