Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

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. [1]

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. [2]

Title: Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes [3]
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.
Baseline Characteristics
Number of events Paclitaxel-Eluting Stents

(n =914)

Everolimu- Eluting Stents

(n=916)

Age, yrs 58.04 +/-9.21 58.34 +/-9.12
Body mass index, kg/m2 25.77 +/-4.02 25.87 +/- 4.25
Insulin requiring diabetes, no. (%) 365 (39.9) 382 (41.7)
Glycated hemoglobin, % 8.40 +/-1.84 8.18 +/- 1.66
Duration of diabetes, yrs 6.75 +/-7.09 6.14 +/-6.69
Total number of lesions 1,133 1,191
Results
Number of events

(% of patients)

Paclitaxel-Eluting Stents

(n=914)

Everolimu- eluting Stents

(n = 916)

p-value
Target- vessel failure § 51 (5.6) 27 (2.9) 0.005

§; 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.

References

 

  1. Fox CS. Cardiovascular Disease Risk Factors, Type 2 Diabetes Mellitus, and the Framingham Heart Study. Trends in cardiovascular medicine. 2010;20(3):90-95.
  2. 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.
  3. Kaul U, Bangalore S, Seth A, et al. Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes. N Engl J Med. 2015;
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