The new-generation Resolute zotarolimus-eluting stent is at least as good as the Xience V everolimus-eluting stent and could be a safe and effective alternative for patients in everyday clinical practice, according to the long-term results (2 year) of the RESOLUTE All Comers trial, to be presented at the American Society of Cardiology meeting in New Orleans and published simultaneously Online First in The Lancet.
Drug-releasing (eluting) stents are used to reduce rates of restenosis (re-narrowing) of coronary arteries in patients with coronary artery disease. However, most trials have been limited to lower risk patients without complex disease or comorbidities. There is a scarcity of long-term safety and efficacy data from randomised studies of new generation drug-eluting stents in a patient population representative of routine clinical practice.
The RESOLUTE All Comers trial was established to compare the safety and effectiveness (as measured by occurrence of target lesion failure—cardiac death, heart attack attributed to the treated vessel, and target lesion revascularisation [repeat procedure to unblock a blood vessel]) of the Resolute zotarolimus-eluting and Xience V everolimus-eluting stents in a trial designed to reflect everyday clinical practice, by including patients with more complex lesions and acute coronary syndromes. Patients from 17 centres in Europe and Israel were randomly assigned to the zotarolimus-eluting stent (1140) or the everolimus-eluting stent (1152).
In 2010, initial results (at 1 year) showed the zotarolimus-eluting stent to be at least as good as the everolimus-eluting with target lesion failure rates of 8.2% vs 8.3%.
In this study, Professor Sigmund Silber from the Heart Centre at the Isar, Munich, Germany and colleagues report the long-term (2 year) outcomes from the RESOLUTE trial with a specific focus on comparing patient related (any death, all heart attacks, all revascularisation) and stent-related outcomes.
At 2 years, the similar safety and efficacy of the two stents was sustained. A patient-related outcome occurred in 231 patients in each group. The number of stent-related outcomes was substantially lower, but did not differ between the groups (126 zotarolimus vs 121 everolimus).
Three patients in each group had a definite or probable stent thrombosis (the formation of a blood clot in a blood vessel) during the second year, but none of them died.
The authors point out that the considerably greater number of patient-related than stent-related events in a diverse patient population with varying disease complexity and comorbidities shows that: "The patients' underlying disease affects the long-term outcomes to a greater extent than does the need for repeat revascularisation or stent thrombosis…[therefore] the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion."
They conclude: "The safety and efficacy of these two [new generation] drug-eluting stents are clinically equivalent, even after 2 years, in a mostly complex population."
In a Comment, Jens Lassen from Aarhus University Hospital, Skejby, Denmark says: "The most important take-home message of the 2-years result of the RESOLUTE All Comers trial is that the overall non-inferiority result was preserved even after cessation of dual antiplatelet therapy, and that the low rate of very late stent thrombosis seems to be achieved without a major increase in late target lesion revascularisations."
Journal
The Lancet