Janet Kairu, Mercer University College of Pharmacy
According to the American Heart Association, patients with diabetes have a two to four fold increased risk of coronary artery disease because accelerated and more diffuse coronary artery disease with increased need for revascularization therapy. 
A review of two studies comparing paclitaxel eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However according to the authors, these trials were not powered for superiority in clinical end points. 
|Title: Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes |
|Design||Multicenter, randomized clinical trial, N = 1,830|
|Objective||To compare paclitaxel-eluting stents with everolimus-eluting stents in patients with diabetes|
|Study Groups||Patients were randomly assigned in a 1:1 ratio to receive either a paclitaxel-eluting stent (n = 914) or an everolimus-eluting stent (n = 916)|
|Methods||Patients with diabetes mellitus and coronary artery disease who were undergoing PCI were randomly assigned to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. A noninferiority margin of four percentage points for the upper boundary of the 95% confidence interval of the risk difference was set.|
|Duration||June 2011 and March 2014|
|Primary Outcome Measure||The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.|
§; All events are ischemia-driven events
|Adverse Events||Common Adverse Events: None reported|
|Serious Adverse Events: None reported|
|Percentage that Discontinued due to Adverse Events: None reported|
|Study Author Conclusions||In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be non-inferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year.|
Although paclitaxel-eluting stents are still available worldwide, they have largely been replaced in clinical practice by newer-generation drug-eluting stents.
The results of this trial provide insight into the debate about the efficacy of limus-eluting stents in patients with diabetes. In addition, the question about the efficacy and safety of everolimus-eluting stents relative to those of paclitaxel-eluting stents in patients with diabetes has important implications for the translatability of the results from previous randomized trials involving patients with diabetes that were conducted with first-generation stents into the modern-day practice of PCI with newer-generation drug-eluting stents.
- Fox CS. Cardiovascular Disease Risk Factors, Type 2 Diabetes Mellitus, and the Framingham Heart Study. Trends in cardiovascular medicine. 2010;20(3):90-95.
- Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362(18):1663-74.
- Kaul U, Bangalore S, Seth A, et al. Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes. N Engl J Med. 2015;