A real all-comers randomized trial comparing Xience Prime and Promus Element stents.

Background: The cobalt chromium everolimus-eluting stent (CoCr-EES) has shown the best safety and efficacy profile in the trials conducted so far. Recently, a new EES with a platinum-based platform (PtCr-EES) has been introduced in the market. There is only one study comparing both stents, but with important exclusion criteria.

Objectives: We sought to evaluate clinical outcomes with the PtCr-EES compared with the CoCr-EES in an all-comers population. We have conducted a randomized all-comers study aimed to compare these stents in a real-practice scenario.

Methods: A total of 300 patients undergoing revascularization and suitable for long-term dual-antiplatelet therapy were randomized 1:1 to CoCr-EES or PtCr-EES. No exclusion criteria based on clinical presentation or lesion characteristics were applied.

Results: The clinical and angiographic characteristics were well balanced in both groups without significant differences. At 18 months, the survival free from death and infarction was 93.9% for CoCr-EES and 91.3% for PtCr-EES (P=.3), the survival free from revascularization was 95.2% vs 94.5% (P=.6) and the survival free from death, infarction, and revascularization was 90.6% vs 88%, respectively (P=.4). The incidence of definite or probable thrombosis was 1.3% for CoCr-EES and 0.66% for PtCr-EES (P=.9). No cases of longitudinal stent compression were observed.

Conclusions: The results of this all-comers trial do not show significant differences between CoCr-EES and PtCr-EES. However, the sample size is not powered to exclude potential differences between stents.