Randomised trial of the comparison of drug-eluting stents in patients with diabetes: OCT DES trial.

Abstract

Background: To date, there have been limited comparisons performed between everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) in patients with diabetes mellitus (DM). The objectives of this study was to assess the use of second-generation drug-eluting stents in patients with DM, using optical coherence tomography (OCT) to compare the level of stent coverage of Boston Scientific Promus Element EES compared with Medtronic Resolute Integrity ZES.(Clinicaltrials.gov number NCT02060357). Methods: This is a single-centre randomised blinded trials assessing two commercially available stents in 60 patients with diabetes (ZES: n=30, EES: n=30). Patients underwent intracoronary assessment at 6 months with OCT assessing stent coverage, malapposition, neointimal thickness and percentage of in-stent restenosis (ISR). Results: Of the 60 patients randomised, 46 patients underwent OCT analysis. There was no difference in baseline characteristics between the two groups. Both Promus Element and Resolute Integrity had low rates of uncovered struts at 6 months with no significant difference between the two groups (2.44% vs 1.24%, respectively; P=0.17). Rates of malapposition struts (3.9% vs 2.5%, P=0.25) and percentage of luminal loss did not differ between stent types. In addition, there was no significant difference in major adverse cardiovascular events (P=0.24) between the stent types. Conclusions: This study is the first randomised trial to evaluate OCT at 6 months for ZES and EES in patients with diabetes. Both stents showed comparable strut coverage at 6 months, with no difference in ISR rates at 6 months.