Lancet Reports on Results of a Stent Safety and Efficacy Comparison Trial
Published date : 04 February 2013
Article date : 04 February 2013
The Lancet (30 January 2013) summarises the results of a recent trial which compared the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with that of a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer.
COMPARE II was a randomised, controlled and non-inferiority trial where patients received dual antiplatelet therapy for 12 months, after discharge. From Jan 12, 2009, to Feb 7, 2011, 2707 patients (4025 lesions) were enrolled, 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months follow-up.
Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5·9%] vs 19 [2·1%]; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 [95% CI 0·75—1·52]; pnon-inferiority<0·0001). Analysis per protocol did not change the outcome of this trial (pnon-inferiority<0·0001).
The trial results concluded that biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. The article also says that there is a need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent.
