Impact of Diabetes Mellitus on 5-year Outcomes After PCI with a Polymer-Free Drug-Coated Stent or a Biodegradable Polymer Ultra-Thin Strut Stent.

Diabetes mellitus (DM) is a known risk factor for cardiac events in patients undergoing percutaneous coronary intervention (PCI). It remains unclear whether specific stent types improve long-term outcomes in this population. This substudy of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial compared long-term outcomes in patients with DM with either the polymer-free biolimus A9-coated BioFreedom stent (BF-BES) or the ultra-thin strut, biodegradable polymer sirolimus-eluting Orsiro stent (O-SES). SORTOUT IX was a randomized, noninferiority trial allocating patients to BF-BES or O-SES. The primary endpoints was target lesion failure (TLF), consisting of cardiac death, target lesion-related myocardial infarction (MI), and target lesion revascularization (TLR), and stent thrombosis within 5 years in patients with DM. Among 3,151 patients enrolled, 607 (19.3%) had DM (BF-BES: 304; O-SES: 303). At 5 year, TLF was higher for patients with DM than those without DM (19.9% vs 11.4%, rate ratio (RR) 1.48; 95% confidence interval (CI) 1.15 to 1.91). In patients with DM, TLF was similar between BF-BES and O-SES (21.7% vs 18.2%; RR 1.11; 95% CI; 0.76 to 1.62). Rates of cardiac death, TLR and stent thrombosis did not differ significantly. In-stent restenosis was higher for BF-BES within 1 year (4.6% vs 1.0%; RR 4.20; 95% CI 1.20 to 14.7), but not after 5 years (5.9% vs 10.2%; RR 1.56; 95% CI 0.85 to 2.85). In patient with DM undergoing PCI, rates of TLF, cardiac death, target MI, TLR and stent thrombosis did not differ between BF-BES and O-SES after 5 years.