Drug-coated balloon and diabetes mellitus: a matter of survival

Abstract Background Patients with diabetes mellitus (DM) are at higher risk of restenosis and stent thrombosis after percutaneous coronary intervention and drug eluting stent (DES) positioning. Limited although interesting data are available on prognosis after revascularization with drug–coated balloon (DCB) in this group of patients. The aim of this study is to evaluate the prognostic impact of DCB use in patients affected by DM. Methods Patients with DM enrolled in a retrospective multicenter registry were identified and matched to a control population of diabetic patients treated with DES enrolled in another retrospective registry, according to a propensity score calculated on the independent predictors of main adverse cardiac events (MACE). The primary study endpoint was the occurrence of MACE, a composite of death, myocardial infarction, and target vessel revascularization. Secondary endpoints were the independent components of the primary endpoint, or target lesion failure (TLF). Results 150 patients were identified in the DCB group and matched with 150 DES–treated patients. However, patients treated with DCB displayed more often a previous cardiovascular history and received a more complete pharmacological therapy. Target vessel diameter and the percentage of stenosis were lower in DCB patients, whereas binary in–stent restenosis was more common. At a median follow–up of 545.5 days, MACE occurred in 54 (19.4%) of the patients, with no difference according to the PCI strategy. Although a trend toward higher TLF was found (p=0.06), overall death was significantly reduced in diabetic patients (3.6% vs 10.9%; adjusted HR[95%CI]= 0.27[0.08–0.91], p=0.03). Conclusion Although limited by some differences among the groups, the present propensity–matched study shows that, among patients with DM undergoing PCI for in–stent restenosis or de novo lesions, the use of DCB is associated to a similar rate of MACE and a possible increase in TLF, but a significantly improved survival as compared to use of DES.