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.
- bare metal stent
- duel antiplatelet therapy
- drug eluting stent
- diabetes melatus
- non ST elevation myocardial infarction
- optical coherence tomography
- percutaneous coronary intervention
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Contributors AK, AM and SMG conceived of the study. AK, AM, SMG and CJK initiated the study design and SH and DAJ helped with implementation. DAJ, SH, KSR and JL conducted recruitment and trial management. SH and AB performed imaging analysis. DAJ conducted the primary statistical analysis. All authors contributed to refinement of the study protocol and approved the final manuscript.
Funding This study was funded by an unrestricted grant from Medtronic.
Competing interests None declared.
Ethics approval The trial was approved by an independent ethics committee registered at approved registries (Clinicaltrials.gov: NCT02060357).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No current data are published in journals from this study. No further data are available for publication apart from this paper.
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