Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents

Abstract

Background New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. Methods In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated targetlesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. Results At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P = 0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P = 0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimusstent group (P = 0.08). There were no significant between-group differences in the rate of adverse events. Conclusions At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria.

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

“…However, ST had occurred more frequently in patients treated with R-ZES when compared with patients treated with EES at 12 months. 23 Although this early difference in the risk of definite ST diminished during long-term follow-up, 24 there remains uncertainty whether R-ZES and EES feature a different propensity for ST during the periprocedural period. 7,25 Although many randomized trials directly comparing R-ZES and EES were conducted, all of these studies had an inadequate sample size to assess the individual components of the primary composite end points.…”

Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial

“…The sample size calculation was based on event rates reported in the COMPARE trial (12), the RESOLUTE AC trial (16), and the LESSON registry (3), assuming a TLF rate of 8% at 12 months in both treatment arms. A non-inferiority margin of 3.5% was defined for non-inferiority of the O-SES compared with the X-EES.…”

Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

“…В группе стента «Калипсо» частота определенного тромбоза составила 0,49%, что не превышает показатели других исследований [14]. В одном случае определенный тромбоз стента был связан с невозможностью расправить стент в целевом поражении, что впоследствии привело к тромбозу стен-та.…”