Three-year safety and efficacy of treating all-comers with newer-generation Resolute Integrity or PROMUS Element stents in the randomised DUTCH PEERS (TWENTE II) trial.

Abstract

The aim of this report was to assess the three-year safety and efficacy of implanting newer-generation Resolute Integrity zotarolimus-eluting stents (ZES) versus PROMUS Element everolimus-eluting stents (EES) in all-comers. In the randomised, multicentre, investigator-initiated DUTCH PEERS trial, a total of 1,811 all-comers were 1:1 randomly assigned to treatment with ZES versus EES. A total of 1,293 patients (72%) were treated for complex lesions and 455 patients (25%) were treated for multiple lesions. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction or target vessel revascularisation. Adverse clinical events were independently adjudicated. Three-year follow-up data were obtained in 1,807 patients (99.8%, four withdrawals). Both the ZES and EES groups showed favourable outcomes with a similar incidence of TVF (10.7% vs. 10.3%; pLog-rank=0.77) and the individual components thereof: cardiac death (3.2% vs. 3.1%; pLog-rank=0.87), target vessel-related myocardial infarction (2.8% vs. 2.2%; pLog-rank=0.44) and target vessel revascularisation (6.0% vs. 6.2%; pLog-rank=0.87). In addition, the incidence of definite or probable stent thrombosis was similar for patients treated with ZES versus EES (1.4% vs. 1.1%; pLog-rank=0.66). The safety and efficacy of treating all-comers with newer-generation Resolute Integrity and PROMUS Element stents was found to be extended up to three years.