Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial

AIMS: The 12-month results of RESOLUTE were favourable for the new Resolute stent. Two-year safety and efficacy results from RESOLUTE have been evaluated and are now reported. METHODS AND RESULTS: RESOLUTE was a prospective, multicentre, non-randomised, single-arm, controlled trial of the Resolute stent in 139 participants with symptomatic ischaemic heart disease due to single de novo lesions in a native coronary artery. The 2-year rates of MACE (all-cause death, myocardial infarction, emergent cardiac bypass surgery, and target lesion revascularisation [TLR]), death, late stent thrombosis, target vessel revascularisation (TVR), and target vessel failure (TVF) were assessed. Clinical events included two MACE (one TLR; one non-cardiac death) occurring between year one and two resulting in cumulative 2-year TLR, TVR, and TVF rates of 1.4 , 1.4 , and 7.9 , respectively. One possible stent thrombosis event occurred in the first year after stent implantation however no late or very late ARC-defined definite and probable stent thromboses occurred through two years.