Resolute Integrity zotarolimus-eluting stents showed similar 5-year incidence of target vessel failure compared to PROMUS Element everolimus-eluting stents (13.2% vs. 14.2%; p=0.62).
RCT (n=1,811)
Single-blind
1:1
Yes
Does zotarolimus-eluting stents (ZES) reduce target vessel failure compared to everolimus-eluting stents (EES) in an all-comers population?
At 5-year follow-up, Resolute Integrity ZES and PROMUS Element EES showed similar and sustained safety and efficacy in an all-comers population.
Absolute Event Rate: 13.2% vs 14.2%
p-value: p=0.62
The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts). The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices. In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated. Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83). At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.
Zocca et al. (Thu,) conducted a rct in Coronary artery disease requiring stenting (n=1,811). Resolute Integrity zotarolimus-eluting stents (ZES) vs. PROMUS Element everolimus-eluting stents (EES) was evaluated on Target vessel failure (TVF) (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) (p=0.62). Resolute Integrity zotarolimus-eluting stents showed similar 5-year incidence of target vessel failure compared to PROMUS Element everolimus-eluting stents (13.2% vs. 14.2%; p=0.62).