Background: Patients with diabetes mellitus (DM) undergoing coronary revascularization are at increased risk for adverse outcomes. Without sufficiently powered data from diabetic subgroup analyses and in absence of randomized controlled trials in diabetic patients with primary clinical outcomes controversy is ongoing over safety and efficacy of drug-eluting stents (DES) in diabetic patients.
Methods and results: Between October 2005 and October 2006, 1,659 diabetic and 3,559 non-diabetic patients treated with DES (Paclitaxel or Sirolimus-eluting stents) were enrolled at 98 Drug-Eluting-Stent.DEutschland (DES.DE) sites. Major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction, and stroke, as well as target vessel revascularization (TVR) were defined as primary endpoints. The baseline clinical and descriptive morphology of coronary artery disease revealed more severe findings in diabetic patients. At 1-year follow-up, diabetic patients treated with DES had significantly higher rates for overall death (5.6 vs. 3.4%; p < 0.01), myocardial infarction (4.8 vs. 3.4%; p = 0.05), stroke (1.7 vs. 0.9%; p < 0.05), MACCE (10.9 vs. 7.1%; p < 0.001), and overall stent thrombosis (4.9 vs. 3.3%; p < 0.01) with slightly elevated rates for TVR (12.0 vs. 10.4%; p = 0.17); data which remained after risk-adjustment.
Conclusion: Data collected in DES.DE revealed that despite the use of DES the risk of myocardial infarction, death, and thrombotic events remains higher in diabetic patients.