Circulation has featured the results of a trial comparing the sirolimus-eluting stent (n=1,384) with the everolimus-eluting stent in patients with coronary artery disease (1,390). The Scandinavian Organization for Randomised Trials with Clinical Outcome IV trial was a randomised multicentre, single-blind trial comparing the two types of stents in patients with coronary artery disease - the primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) parameters. The trial was powered for assessing non-inferiority of everolimus-eluting stent to sirolimus-eluting stent with respect to the primary endpoint at 9 months. The non-inferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9-month and 18-month follow-up.
The following results were reported:
• The composite primary endpoint occurred in 68 patients [4.9%] in the everolimus-eluting stent group and in 72 patients [5.2%] in the sirolimus-eluting stent group.
• Non-inferiority of the everolimus-eluting stent was established, with a 9-month absolute risk difference of -0.3% and the upper limit of the one-sided 95% confidence interval at 1.1% (p for non-inferiority= 0.02). At 18-month follow-up, this differential remained: 99 [7.2%] patients treated with the everolimus-eluting stent versus 105 [7.6%] (hazard ratio HR=0.94, 95% CI: 0.71-1.23).
• Definite stent thrombosis occurred within 9 months in 2 patients [0.1%] in the everolimus-eluting stent group and in 9 patients [0.7%] in the sirolimus-eluting stent group (p=0.053).
• At 18-month follow-up, definite or probable stent thrombosis did not differ between the two groups as it occurred in 15 patients [1.1%] in the everolimus-eluting stent group and in 16 patients [1.2%] in the sirolimus-eluting stent group (p = 0.85)
The researchers concluded that the everolimus-eluting stent was found to be non-inferior to the sirolimus-eluting stent for patients treated with percutaneous coronary intervention.