Uncovered struts compromise re-endothelization and may induce thrombosis. The new stent approved in China and already used in more than 50,000 patients, is a sirolimus-eluting device with a bio-degradable polymer. Animal studies showed rapid and complete endothelialization. The study included 20 patients with stable angina randomized on a 1:1 ratio to receive, in the same lesion and with an overlap, the proximal sirolimus-eluting stent and the distal everolimus-eluting stent vs the proximal everolimus-eluting stent and the distal sirolimus-eluting stent. The primary endpoint was the coverage of struts after three months and the secondary endpoint was the anual coverage and the clinical events.
After 3 months, there was no difference in relation to the coverage of struts and intimal thickness between the two stents. There was a difference was observed in luminal loss (everolimus 11.3 ± 4.1 mm vs. sirolimus 10.3 ± 3.8 mm, p<0.001), poor apposition (everolimus 0.4% vs. sirolimus 0.1%, p<0.001). These results were maintained after 12 months. The struts of the stents were found well covered after 3 and 12 months, with a difference in favor of the sirolimus-eluting stent (99.2% vs 98.2%, p<0.001).
Conclusion: the BuMA sirolimus-eluting stent presents an earlier endothelization than the everolimus-eluting stent.
jingbo_hou_europcr
Jingbo Hou
2013-05-22
Título original: A prospective randomised controlled 3- and 12-month OCT study to evaluate the endotelial healing between a novel sirolimus-eluting stent BuMA and an everolimus-eluting stent XIENCE V.