Two-Year Results of an Open-Label Randomized Comparison of Everolimus-Eluting Stents and Sirolimus-Eluting Stents

<div><p>Background</p><p>Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES) with first generation sirolimus-eluting stents (SES).</p><p>Methods</p><p>A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis.</p><p>Results</p><p>In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2±11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES). In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68–1.48). Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types.</p><p>Conclusion</p><p>In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice.</p><p>Trial registration</p><p>TrialRegister.nl <a href="http://trialregister.nl/ct2/show/NTR3170" target="_blank">NTR3170</a></p></div