German DES.DE Study Compares SES and PES in Diabetic Patients

July 1, 2010—One-year results from the DES.DE (Drug-Eluting Stent.Deutschland) registry were published by Ibrahim Akin, MD, et al in Catheterization and Cardiovascular Interventions (2010;76:50–57). DES.DE studied outcomes after differential DES use in diabetic patients.

According to the investigators, the prospective multicenter German DES.DE registry provides real-world data to evaluate the therapeutic principle of two different DES (sirolimus- [SES] and paclitaxel-eluting stents [PES]) in the context of the German Health System. The background of the study is that differential DES have been effective in randomized trials, but the difference in safety and efficacy in diabetic patients has not been well studied.

In the study, investigators recorded baseline, predefined procedural, clinical in-hospital, and follow-up events for 1,526 diabetic patients. The primary endpoint was the composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events and target vessel revascularization.

The investigators reported that between October 2005 and October 2006, 1,526 diabetic patients (34.2% insulin-dependent) were enrolled (SES, n = 612; PES, n = 914) at 98 DES.DE sites. Overall, one-third of patients were admitted with acute coronary syndrome, and 70% had multivessel disease, reflecting a real-world scenario. With similar baseline, clinical, and descriptive morphology of coronary artery disease in both DES groups, there were no statistical differences in 1-year follow-up with respect to overall mortality (5.8% vs 5.4%), target vessel revascularization (12% vs 11.3%), overall stent thrombosis (5.6% vs. 4.6%), and major adverse cardiac and cerebrovascular event (11.4% vs 10.3%) rates between both DES. The data collected in DES.DE revealed no differences in clinical outcomes within 1 year between SES and PES in diabetic patients in a real-world setting, the investigators concluded.