Everolimus proves superior in real-world analysis

Although drug-eluting stents (DES) are known to reduce the risk of restenosis, and hence the need for reintervention, in patients at high risk of restenosis enrolled in randomised clinical trials, there is little ‘real-life’ data currently available.  The COMPARE study (second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) aimed to compare the safety and efficacy of second-generation everolimus and paclitaxel-eluting stents in real –life practice.

1800 patients were randomly assigned to treatment with either a Xience V or a Taxus Liberté stent in a 1:1 ratio.  Patients were unaware of which stent they had been assigned to.  The primary endpoint was a composite of safety and efficacy (all cause-mortality, myocardial infarction, and target vessel revascularisation) within 12 months.
In the 1797 patients who completed follow-up, the primary endpoint occurred in 56 (6%0 of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 patients in the paclitaxel-eluting stent group (relative risk 0.69, p value for superiority =0.02).  Lower rates of each of the three main components of the primary endpoint was seen in the everolimus group (see figure).  In terms of clinical outcomes, cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 (5%) of patients in the everolimus-eluting stent group versus 74 (8%) patients in the paclitaxel-eluting stent group (p value for superiority = 0.005).  Although the trials showed a particular benefit for using everolimus-eluting stents in non-diabetics (relative risk 0.61, p=0.01), this benefit was not seen in diabetic patients.
Conclusions:
In this real-world analysis, an everolimus-eluting stent proved superior to a second-generation paclitaxel-eluting stent in terms of efficacy and safety.  However, no benefit was seen in the diabetic subgroup, and further trials are needed to clarify which stent is superior in this group of patients.
• Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-Generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): A randomised trial. Lancet 2010, Jan 7.

(Visited 38 times, 1 visits today)