Comparison of long-term clinical outcomes after the second-generation cobalt–chromium sirolimus-eluting stents implantation in diabetic versus non-diabetic patients: a subgroup analysis from the prospective FOCUS registry

Abstract

Background: Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt–chromium sirolimus-eluting stents (CoCr-SES) was less known. Methods: A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching. Results: The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p = 0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p = 0.938) and target lesion revascularization (1.2% versus 1.1%; p = 0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p = 0.012) demonstrated a significant increase in the DM group. Conclusions: This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.Key messagesThe overall rate of adverse clinical events in both diabetic and non-diabetic patients was <10%, indicating a satisfying long-term safety and efficacy performance of CoCr-SES, even in high–risk diabetic patients.DM significantly increased the risk of MACE (HR 1.3; 95% CI: 1.0–1.6) in patients undergoing CoCr-SES implantation.