The study will be a prospective, multicenter, randomized controlled trial in patients with diabetes mellitus undergoing PCI with the novo coronary disease.~A total of 96 diabetic patients with de novo coronary artery stenosis will be included.~After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:~A) Study group: Pre-dilation with cutting balloon followed by ASES implantation.~B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.~Stent optimisation will be performed based on intracoronary imaging findings.
Diabetes mellitus is one of the most important diseases worldwide. Patients with diabetes mellitus, as compared to those without, present a more diffuse, progressive coronary artery disease with smaller lumen dimensions leading to suboptimal outcomes after PCI and increased risk of restenosis and adverse cardiac events.~Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions in patients at high risk of restenosis.